Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits

Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits; Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile
Stryker's Craniomaxillofacial (CMF) business unit announced today that the U.S. Food and Drug Administration (FDA) concluded on Dec. 18, 2008 that its recall of the following Stryker CMF's Custom Cranial Implant Kits is a Class I recall, which means the product could pose an imminent hazard to health: Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile.

The notification relates to a nationwide voluntary recall initiated by Stryker CMF on Oct. 24, 2008 of 322 Custom Cranial Implant Kits after determining that the sterilization validation of the product was not performed according to appropriate standards. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.

Physicians and hospitals who have product that corresponds to the catalogue numbers listed above should stop implanting the product immediately and return it to Stryker CMF. Stryker recommends that patients who have received these implants be monitored by their physicians for signs of infection for at least six months post-implantation.

Stryker CMF previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits and requested that they return any remaining products to Stryker CMF. Stryker CMF will again notify implanting surgeons, risk managers and its sales representatives of this recall and its potential health risk and request that physicians or hospitals return to Stryker CMF any of this product that has not been implanted.

Physicians and patients with questions related to this issue should contact Stryker CMF at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET. Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. For more information about Stryker, please visit www.stryker.com.

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Massive Cuts to Medicare Home Oxygen Therapy Benefit Taking Effect January 1 Creating Acute Anxiety Among Beneficiary and Provider Communities

/PRNewswire-USNewswire/ -- As Americans nationwide prepare to celebrate the New Year, the home oxygen community is looking to 2009 with great unease due to significant Medicare policy changes that will present many challenges to beneficiaries and providers alike. On January 1, two new policies in the form of a 36-month cap on payments for home oxygen therapy and a 9.5 percent across-the-board payment cut will take effect, deeply impacting a community that cares for more than 1.5 million elderly and chronically ill patients.

Under the new 36-month cap, Medicare will stop payment for stationary home oxygen therapy equipment and related services after the beneficiary reaches the three year mark. Despite the discontinuation of payments after 36 months, providers will still be required to continue all servicing of patient needs and equipment including patient-generated, non-routine emergency home visits and routine replacement of disposable oxygen supplies, such as tubing and masks. Providers will also be responsible for ensuring that patients are appropriately serviced even if the patient moves out of the provider's service area within or following the first 36 months of service.

"The provider community is extremely committed to making every effort to meet patient needs and provide uninterrupted services," said Peter Kelly, Chairman of the Council for Quality Respiratory Care (CQRC). "However, it is difficult to comprehend how providers can maintain patient service levels on an uncompensated basis. Based on the magnitude of these cuts, the provider community cautions that service reductions may be unavoidable as a result of business failures or financial hardship and cause potential access problems for the vulnerable patient population we care for."

Historically, the home oxygen benefit has been subject to repeated cuts. The implementation of the 36-month cap, enacted by Congress in the Deficit Reduction Act of 2005 (DRA), and the 9.5 percent cut, part of the Medicare Improvements for Patients and Provider Act of 2008 (MIPPA), translate to a 27 percent, or $845 million, cut in 2009 alone. A recent analysis from Avalere Health "indicates that the average Medicare home oxygen payment by 2009 will be less than half of what it was in 1997."

The CQRC urges Centers for Medicare and Medicaid Services (CMS) officials to exercise the Secretary's authority to create reasonable post-cap policies, including payments for emergency and non-routine services and reimbursement for disposable supplies after 36 months. CMS should also reset the cap when a beneficiary moves out of his or her service area and requires a new provider. The CQRC asks policymakers to closely monitor the effects of these deep cuts on both beneficiaries and providers to ensure that patient access to essential home oxygen care is not compromised. Ultimately, the home oxygen community hopes to work with policymakers to develop thoughtful, comprehensive reforms of Medicare policies that protect patient access to quality oxygen care.

"We want all patients to have complete access to all services related to their home oxygen care, throughout their entire period of medical need," added Kelly. "With more than one quarter of home oxygen beneficiaries requiring oxygen for more than 36-months, the impact of the cap, coupled with the dramatic 9.5 percent cut, is going to resonate throughout the oxygen community. Although providers are working hard to prepare for the approaching payment changes, these cuts are simply unsustainable and may negatively impact beneficiary care."

The Council for Quality Respiratory Care is an alliance of the nation's leading home oxygen therapy providers and manufacturers, representing nearly one half of the 1.5 million Medicare beneficiaries who depend on the home oxygen benefit for independence and quality of life.

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FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue

The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue.

“With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research.

Nucleic acid is the common name for the large chemical compounds that make up the genetic material in living cells. The new FDA-approved test detects nucleic acid from HIV-2 and from HIV-1 Group O. HIV-2 infections and HIV-1 Group O infections are predominantly found on the African continent. Some cases of infection with these two types of viruses have also been detected in the United States.

In addition to HIV-2 and HIV-1 Group O, the MPX test simultaneously detects nucleic acid from the most common form of HIV, HIV-1 Group M, as well as the Hepatitis C Virus and the Hepatitis B Virus.

The MPX test is designed for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma. Donated source plasma is considered plasma intended for further manufacturing.

The test is also intended for screening tissue specimens obtained while the donor’s heart is still beating; it is not intended for use on specimens from donors whose heart no longer functions.

The cobas TaqScreen MPX Test runs on the fully-automated cobas s 201 System. It is manufactured by Roche Molecular Systems Inc., Pleasanton, Calif.

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Changing The Way Scoliosis is Treated

24-7 -- The study found that "positive outcomes are maintained after 2 years because 45 (95.7%) of 47 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing."

In a second study comparing the effectiveness of the SpineCor soft brace with several traditional hard braces, the outcome showed that 96 percent of the patients wearing the SpineCor soft brace experienced a curvature progression of 5 degrees or less after 2 years of follow-up care. Whereas, only 15 percent of study patients wearing the traditional TLSO brace and 31 percent of study patients wearing the Providence brace experienced a 5 degree or less progression after two years of follow-up care. This clearly shows that the SpineCor soft brace successfully halts progression of the child's curvature when treated properly.

Scoliosis Specialists, a group of Chiropractors with offices in New York, Atlanta, Chicago and Los Angeles, have been trained and using the soft brace for several years now and patients are experiencing very positive results.

"The SpineCor soft brace is a very exciting advancement in the treatment of pediatric idiopathic scoliosis and will undoubtedly have a significant impact on the way doctors treat the disease," explained co-founder of Scoliosis Specialists, Brian Ouellette, DC.

"The SpineCor brace gives the patient a level of comfort and flexibility which is nearly impossible in the traditional hard brace. Ultimately, it allows kids to be kids and to participate in physical activities such as gym class, soccer and dance class."

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Asthma Sufferers Breathe Easier as Walmart Announces $9 Environmentally Sustainable Inhaler

/PRNewswire-FirstCall/ -- As part of its continued commitment to provide accessible, affordable medications to those who need it most, Walmart today announced it will carry an environmentally friendly albuterol rescue inhaler starting at $9, the lowest-priced inhaler on the market. The ReliOn(R) Ventolin HFA inhalers, sold exclusively at Walmart*, will ease the transition as asthma sufferers are forced to replace their CFC-powered inhalers with new HFA inhalers in the new year to comply with an FDA mandate.

"While some HFA inhalers may sell for as much as $60 for certain brands, our $9 ReliOn Ventolin HFA inhaler will ease the financial burden for sufferers of asthma who should not go without these life-saving medications," said Sandy Kinsey, Walmart's divisional merchandise manager for pharmacy. "As an advocate for our customers, we're committed to ensuring they have access to affordable medicine they cannot live without."

According to the 2007 National Institutes of Health (NIH) asthma treatment guidelines, overuse of albuterol is a sign of uncontrolled asthma. With 60 metered inhalations, the ReliOn Ventolin HFA inhaler helps both patients and health care professionals monitor and track usage via the dose counter to identify overuse of albuterol. Additionally, it helps patients track how many puffs remain in their inhaler so they do not run out of their rescue medication when they need it most.

Walmart offers other affordable medications* for those suffering from the disease, including:

Albuterol 2mg tab $4 for 90 tablets $10 for 270 tablets
Albuterol 4mg tab $4 for 60 tablets $10 for 180 tablets
Albuterol 2mg/5ml syrup $4 for 120ml $10 for 360ml


For further information about Walmart's affordable prescription program, customers can visit http://www.walmart.com/pharmacy or discuss the program with their local Walmart, Neighborhood Market or Sam's Club pharmacist.

* Products and pharmacies are not available in North Dakota

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Maternity Center at Piedmont Fayette Hospital Offers Classes for Expecting Parents

Parents and expectant parents are invited to attend several informative classes offered by the Maternity Center at Piedmont Fayette Hospital (PFH). For more information on the Maternity Center at PFH, visit www.fayettehospital.org. Community members are invited to take part in the following classes:

Prepared Childbirth Class - This course, recommended for women 20 to 28 weeks into pregnancy, provides an eight hour childbirth education class that teaches mom and her partner about what to expect during labor and delivery. The instructor will discuss the stages of labor, relaxation, breathing techniques, common concerns, comfort measures and much more. Participants will need to bring two pillows and a blanket or towel. The fee for the course is $85 and includes light refreshments. The class will be held Saturday, Jan. 17 from 9 a.m. to 5 p.m. in the Dietary Conference Room on the ground floor of the hospital. To register, call Link2Health toll-free at 1-866-900-4321. For more information call 770-719-6305.

Breastfeeding Basics - The Maternity Center at Piedmont Fayette Hospital offers a three hour group participation discussion on the benefits and how-to's of breastfeeding. This class includes preparing for breastfeeding and getting started in the hospital and at home, special situations and growing a breastfeeding family. The class is best if done prior to delivery, but participants are welcome at any time. Fathers and grandparents are welcomed and encouraged to attend also. This class is now offered every month, and the next class is Saturday, Jan. 10 from 9 a.m. to Noon in the Dietary Conference Room on the ground floor of the hospital. To register, call Link2Health toll-free at 1-866-900-4321. For more information call 770-719-6305.

Moms in Motion - “Moms in Motion” is a fitness program designed to prepare women for the physiological changes that occur during pregnancy and postpartum. The class combines low impact aerobics, toning exercises, relaxation and breathing techniques and appropriate warm-ups/cool-downs perfect for both pregnant and postpartum women. The program provides not only a safe and effective exercise regime, but also provides valuable information on pregnancy, postpartum and child safety. Participants may register for this ongoing program at any time during or after pregnancy. Classes are held every Tuesday and Thursday from 5:15 to 6:15 p.m. in Suite 200 of the Piedmont Fayette Hospital Fitness Center at 1250 Hwy 54 West. Space is limited. The classes are FREE to fitness center members, and $25 per month for non-members. Written approval from a physician is required. For more information or to register, call 770-719-7290.

Maternity Center Tours - The Maternity Center at Piedmont Fayette Hospital welcomes expectant mothers and their families to take a tour of the facility. The tour will be offered on Monday, Jan. 5 from 6 to 7 p.m., Saturday Jan. 10 from 12:30 to 1:30 p.m. and Saturday, Jan. 17 from 6 to 7 p.m. The tour will provide information on the hospital's approach to maternity care and how physicians and staff help new mothers and their babies before and after delivery. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance) and sign in. For more information call 770-719-6305.

Sibling Class - Siblings ages three to ten, accompanied by a parent, are welcome to attend. The class includes a brief tour of the hospital, and will cover the adjustments of becoming a big brother or big sister, as well as what happens to the mother while she is in the hospital. The course will be offered Saturday, January 10th from 2 to 3 p.m. This class is offered the second Saturday of each month. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance) and sign in. For more information or to register, call 770-719-6305.

Fayette County Safe Kids Child Passenger Safety Training Class - Fayette County Safe Kids will offer a car seat safety class to teach parents how to keep children safe, especially while traveling by car. The course will be offered Monday, Jan. 12 from 2 to 3:40 p.m. in Conference Room A on the third floor of the hospital's 1279 Building. This class is offered the second Monday of each month. For additional information contact Debbie Straight, 770-305-5148.
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FDA Approves Drug for Patients with Advanced Prostate Cancer

The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.

Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn't do this.

“Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA.

Prostate cancer is one of the most commonly diagnosed cancers in the United States. In 2004, the most recent year for which statistics are currently available, nearly 190,000 men were diagnosed with prostate cancer and 29,000 men died from the cancer.

Several treatment options exist for different stages of prostate cancer including observation, prostatectomy (surgical removal of the prostate gland), radiation therapy, chemotherapy, and hormone therapy with agents that affect GnRH receptors.

The efficacy of degarelix was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, a drug currently used for hormone therapy in treating advanced prostate cancer. Degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors.

In fact, nearly all of the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.

The most frequently reported adverse reactions in the clinical study included injection site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.

Degarelix is manufactured for Ferring Pharmaceuticals Inc., Parsippany, N.J., by Rentschler Biotechnologie Gmbh, Laupheim, Germany.

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Atlanta Hospital Hospitality House Breaks Ground

The Atlanta Hospital Hospitality House broke ground on the Home Depot Marcus Hospitality Cottage, a handicapped accessible overnight housing facility for patients and families traveling to Atlanta for medical care.

Funded by a grant from the Home Depot Foundation, the new cottage is a 1,400-square-foot facility which will have the capacity to provide lodging, meals and a supportive environment for patients and families receiving treatment in any of the 17 Atlanta area hospitals. The cottage will also serve families from the Marcus Autism Center, which works with children who have developmental disabilities.

“We are excited to have the support from The Home Depot Foundation, and an opportunity to work with the Marcus Foundation,” said CJ Bolster, Chair of the Atlanta Hospital Hospitality House. “The cottage will have an additional four bedrooms that will house up to eight additional guests.”

“Thanks to The Home Depot’s commitment, we will have an open, welcoming and affordable overnight alternative for our families who commute for treatment,” said John Floyd, chief development officer of the Marcus Autism Center. “Because we treat the entire family, this facility will enhance the patient experience and provide a better basis for progress in the future.”

Since its inception in 1981, The Hospitality House has served more than 100,000 guests from all 50 states and 39 different countries. It is the only hospitality house of its kind, serving outpatients and families of inpatients from any Atlanta area hospital regardless of medical condition. The handicap accessible cottage presents a unique partnership between three non-profit organizations to offer a caring environment for patients outside the walls of the medical facility.

“The Home Depot Foundation is dedicated to building homes for families that are healthy and affordable to live in; and this commitment extends to the ‘home away from home’ that the Hospitality House will provide for patients and their families,” said Kelly Caffarelli, president of The Home Depot Foundation. “Built according to EarthCraft House specifications, the cottage will consume less energy and natural resources providing both an environmentally friendly and comfortable home.”

The cottage will be located on the campus of the Atlanta Hospital Hospitality House at 1815 Ponce de Leon Avenue in Atlanta, Ga. For more information about the Hospitality House or the Home Depot Marcus Hospitality Cottage, please call 404-377-6333 or visit www.atlhhh.org.
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FDA Approves First Imaging Agent to Enhance Scans of Blood Flow

The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.

Although MRA can be performed without the use of a contrast imaging agent, Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body.

"This MRA contrast imaging agent provides clinicians with a much clearer scan of blood vessels, compared to MRA without contrast, even in vessels that are difficult to scan because they twist and turn in the body," said John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.

When blood vessels are scanned using MRA without any contrast, radiologists are unable to interpret the images about 10 percent to 30 percent of the time. As a result, radiologists have typically used X-rays to detect blood vessel abnormalities. But this is a lengthy procedure and requires sticking a needle into an artery to inject the X-ray dye, a procedure that may result in injury to vessel walls, blood clots, allergic reactions and potential kidney damage. Vasovist is injected into a peripheral vein and no artery is punctured, thus the potential risks are fewer.

The active substance in Vasovist is gadolinium, a rare earth metal element that is detected by MRI scanners. When injected, gadoliunium interacts with water molecules in the body, giving a stronger signal and, in turn, a better picture.

The safety and efficacy of Vasovist was established in two clinical studies of patients with known or suspected aortoiliac disease --- plaque buildup in the arteries going to the legs. In the studies, patients underwent MRA with and without Vasovist and their scans were compared to standard X-ray pictures using contrast. MRA with Vasovist detected more arterial disease than MRA performed without Vasovist and the pictures were of improved technical quality.

The primary safety risks for Vasovist are allergic reactions and n ephrogenic systemic fibrosis, a rare syndrome that involves the thickening of the skin, joints, eyes and internal organs. The FDA issued a warning about this syndrome in May 2007 and information about it is included in a boxed warning for all drugs containing gadolinium, including Vasovist. The warning can be found here:
http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200705.htm

Vasovist Injection is manufactured by EPIX Pharmaceuticals Inc., Lexington , Mass.

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ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.

If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.

There are other companies in the United States producing and marketing versions of Hydromorphone HCl tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round tablet with a script "E" on one side and a "2" on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact ETHEX as provided below regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the telephone number below or their physician, pharmacist, or other health care provider.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472 or fax to ETHEX Customer Service at 314-646-3751, or e-mail to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST. Consumers who experience any adverse reactions to this drug should contact their physician and/or healthcare provider immediately. Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The Hydromorphone HCl recall announcement is posted on www.kvpharmaceutical.com and www.fda.gov/opacom/7alerts.html. It includes step-by-step details on how to return affected product to KV Pharmaceutical. The Company web site also includes a list of the drugs affected by the suspension.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised the U.S. Food and Drug Administration that, effective midnight Dec. 19, 2008, the company voluntarily suspended shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to expeditiously address manufacturing issues that have come to management’s attention, to review and enhance comprehensively the company’s quality systems, and to implement efficiency improvements in its production facilities. KV is keeping the FDA informed about the Company’s plans.

This recall and suspension are being conducted with the knowledge of the FDA. At this time, the company is unable to determine when distribution of tablet form products will resume, or estimate what the financial impact of the recall and suspension will be.

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KV Pharmaceutical Voluntarily Suspends All Shipments of its Approved Tablet-form Drugs

KV Pharmaceutical has advised the U.S. Food and Drug Administration (FDA) that, effective midnight Dec. 19, 2008, the company voluntarily suspended all shipments of all FDA approved drug products in tablet form. KV Pharmaceutical is also recalling a single production lot of Hydromorphone HCl 2 mg tablets (Lot 90219, Exp: 3/2010; NDC 58177-0620-04), a pain management drug, following the report of an oversized tablet. Additional details on this recall were provided in an ETHEX Corporation press release also issued today and will be posted on www.kvpharmaceutical.com.

At this time, the company is unable to determine when distribution of tablet-form products will resume.

A full list of products included in the suspension of shipments can be viewed on the Company’s website at www.kvpharmaceutical.com, where a link can be found on the home page to “Products Effected by Shipment Suspension”.

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FDA Warns Consumers About Tainted Weight Loss Pills

The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

The tainted weight loss products are:

Fatloss Slimming
2 Day Diet
3x Slimming Power
Japan Lingzhi 24 Hours Diet
5x Imelda Perfect Slimming
3 Day Diet
7 Day Herbal Slim
8 Factor Diet
7 Diet Day/Night Formula
999 Fitness Essence
Extrim Plus
GMP
Imelda Perfect Slim
Lida DaiDaihua
Miaozi Slim Capsules
Perfect Slim
Perfect Slim 5x
Phyto Shape
ProSlim Plus
Royal Slimming Formula
Slim 3 in 1
Slim Express 360
Slimtech
Somotrim
Superslim
TripleSlim
Zhen de Shou
Venom Hyperdrive 3.0

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

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FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST.

GIST is a fairly rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which helps to control the movement of food and liquid through the stomach and intestines.

Gleevec, first approved by the FDA in 2001, is one of the first drugs in a class of agents that block cellular communications that result in tumor growth

"Approval of Gleevec offers health care professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses."

About 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States. Because symptoms of GIST are no different than other GI complaints such as nausea and vomiting, the cancer is difficult to detect early. Patients initially undergo surgery to remove the tumor but GIST commonly recurs. Gleevec is intended to be given to patients following surgery to help prevent tumor recurrence.

The efficacy of Gleevec was established in a clinical trial in which patients received either Gleevec or a placebo for one year after surgical removal of the tumor. The optimal treatment duration is not known.

There were significantly fewer recurrences of GIST in patients receiving Gleevec than in patients who did not. The most frequently reported adverse reactions were diarrhea, fatigue, nausea, swelling of the feet, decreased red blood cell counts, rash, vomiting and abdominal pain.

Gleevec is manufactured by Novartis AG, Basel, Switzerland.

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Mayo Clinic Study Finds Increased Risk of Pneumococcal Disease in Asthma Patients

/PRNewswire-USNewswire/ -- Mayo Clinic research shows adults with asthma are at increased risk of serious pneumococcal disease caused by Streptococcus pneumoniae, the most common bacteria causing middle ear infections and community acquired pneumonia. It also causes blood stream infections and brain infections. According to the Centers for Disease Control, pneumococcal infection is one of the leading causes of death from a vaccine-preventable disease. The researchers recommend including asthma as an indication for pneumococcal vaccination in adults. The results of the study were recently published in the October edition of the Journal of Allergy and Clinical Immunology.

"We found that adults with invasive pneumococcal disease, a serious, potentially fatal disease, are seven times more likely to be asthmatics. Our study also showed that 17 percent of the burden of invasive pneumococcal disease can be attributable to asthma at a population level. This is quite a significant impact on the burden of invasive pneumococcal disease," says Young Juhn, M.D., a pediatric and adolescent medicine physician-scientist at Mayo Clinic and lead author of the study. "Invasive pneumococcal disease is a vaccine-preventable disease. The implication is that we have the ability to significantly reduce instances of this potentially fatal disease by expanding the indication for the pneumococcal vaccine to include adults with asthma."

Researchers used a population-based, retrospective case-control study of 3,941 records from the Rochester, Minn. population to see if there was a higher incidence of pneumococcal disease among people with asthma. Adults diagnosed with asthma were almost seven times more likely to develop invasive pneumococcal diseases than adults who were not diagnosed with asthma. In children the sample size for was not large enough to draw a definitive conclusion.

"The Advisory Committee on Immunization Practices (ACIP), which is the governing body for immunization practices in the United States, voted unanimously to include asthma as a pneumococcal vaccine condition at the recent ACIP meeting in October, 2008. Adults with asthma should receive the pneumococcal vaccine," says Dr. Juhn.

Further research implications include finding out why a connection exists between instances of pneumococcal disease and asthma, determining whether the connection between asthma and this particular bacterial infection also exists with other bacterial infections, such as pertussis (whooping cough), and the connection between asthma and other non-infectious diseases, such as inflammatory bowel disease, juvenile diabetes, and rheumatoid arthritis. Dr. Juhn does not believe all asthmatic patients react the same way. He is looking for a subset of asthmatic patients who have an increased susceptibility to microbial infection.

Study authors, in addition to Dr. Juhn, include Hirohito Kita, M.D., Department of Allergic Diseases Research, Mayo Clinic; Barbara Yawn, M.D., Department of Epidemiology, Mayo Clinic; Thomas Boyce, M.D., Department of Pediatric Infectious Diseases, Mayo Clinic; Kwang Yoo, M.D., Ph.D., Department of Internal Medicine, Kunkook University, Republic of Korea; Michaela McGree, Department of Biostatistics, Mayo Clinic; Amy Weaver, Department of Biostatistics, Mayo Clinic; Peter Wollan, Ph.D., Department of Epidemiology, Mayo Clinic; and Robert Jacobson, M.D., Department of Pediatric and Adolescent Medicine, Mayo Clinic.

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Emory Makes $20 Million Contribution to Grady

Emory University has agreed to credit Grady Health System with $20 million of the $62 million debt that Grady owed the University as of January 1, 2008.

The voluntary contribution is Emory’s commitment to the business community’s current philanthropic campaign for Grady, which plays a vital role for all of Georgia as the Atlanta metro region’s only Trauma I center and the state’s largest indigent care hospital.

“This is real money, earned by real faculty physicians working under the terms of a mutually agreed upon contract with the Fulton-DeKalb Hospital Authority,” says Thomas J. Lawley, MD, dean of the School of Medicine.

“Although it comes at a time of significant budgetary constraint for the School of Medicine, we also know that shared sacrifice from all of the Atlanta health care community will be required if Grady is to achieve our common goal of not only surviving, but thriving,” says Lawley.

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The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research and health care. Its components include schools of medicine, nursing, and public health; Yerkes National Primate Research Center; the Emory Winship Cancer Institute; and Emory Healthcare, the largest, most comprehensive health system in Georgia. The Health Sciences Center has a $2.3 billion budget, 17,000 employees, 2,300 full-time and 1,900 affiliated faculty, 4,300 students and trainees, and a $4.9 billion economic impact on metro Atlanta.
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FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants

The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.

Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas. Multiple myeloma is cancer of the plasma cell, a cell in the bone marrow that produces antibodies to help fight infection and disease. Non-Hodgkin lymphomas are a diverse group of blood cell cancers derived from lymphocytes, a type of white blood cell.

Prior to receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis in which blood stem cells are collected and stored for reinfusion after therapy. G-CSF is commonly administered to help release and collect stem cells from the bone marrow. Mozobil is an injectable drug that, when used in combination with G-CSF, boosts the number of stem cells released from the bone marrow into the blood stream.

"Collecting the millions of cells needed for a bone marrow transplant can take hours or days," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy."

In two randomized clinical trials – one in patients with non-Hodgkin’s lymphoma, the other with multiple myeloma – Mozobil combined with G-CSF increased the number of stem cells available for collection and transplantation compared with patients receiving G-CSF alone.

The most commonly reported adverse reactions in these trials and other smaller studies were diarrhea, nausea, fatigue, injection site reactions, headaches, joint pain, dizziness and vomiting.

Mozobil is manufactured by Genzyme Corp., Cambridge, Mass.

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FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes

The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.

"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment."

More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.

Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack. This is the purpose of today's guidance, which has benefited from the July 2008 recommendation from FDA's Endocrinologic and Metabolic Drugs Advisory Committee.

The guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required. Specifically, the guidance recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies -- especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.

The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.

The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control. The FDA is continuing to evaluate how today's recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.

The FDA's guidance and its ongoing evaluation of this issue supports our approach to drug regulation throughout the product life-cycle, by evaluating a drug's safety before and after its approval," said Janet Woodcock, M.D., director, CDER, FDA.

"Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted on FDA's website at http://www.fda.gov/cder/guidance/8576fnl.pdf. It will be published in the Federal Register on December 19, 2008. In addition, the FDA has provided written notice of the recommendations from this guidance to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment.

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Piedmont Hospital Honored for Next-Generation Clinical Care

Piedmont Hospital has been named as the healthcare provider in the nation making the best use of clinical data tools “to provide life-saving intelligence at the point of care” by Health Data Management, the premier media company in healthcare IT, as part of the company’s 2nd Annual Editors’ Choice Awards.

The Next-Generation Clinical Care Award given to Piedmont Hospital is part of the prestigious Annual Editors’ Choice Awards that recognize the most innovative health care IT leaders and facilities for their pioneering efforts in using information technology to improve the quality of life of their patients and the financial viability of their organizations.

Award winners are selected by the editorial staff of Health Data Management based on published articles that highlighted individuals and organizations setting new standards of innovation.

According to Health Data Management, while next-generation systems expand the capabilities of hospitals and group practices to support clinicians and improve patient safety by capturing and analyzing clinical data, this award pays tribute to the provider organization making the best use of these new tools to provide life-saving intelligence at the point of care.

“We are pleased Piedmont Hospital was recognized by Health Data Management for our continued commitment to quality initiatives that employ our IT resources to the advantage of those in our care,” said Robert Maynard, president and CEO of Piedmont Hospital. “This national recognition honors our efforts to provide the best quality patient care.”
For more information about Piedmont Hospital visit piedmonthospital.org.
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Cleveland Clinic Surgeons Perform Nation's First Near-Total Face Transplant

/PRNewswire/ -- A multi-disciplinary team of doctors and surgeons at Cleveland Clinic recently performed the first near-total face transplant in the United States.

In a 22-hour procedure performed within the past two weeks, surgeons transplanted 80 percent of a woman's face who suffered severe facial trauma -- essentially replacing her entire face, except for her upper eyelids, forehead, lower lip and chin. For the privacy and protection of those involved, no information will be released on the patient, the donor or their families. (A written statement from the patient's sibling is available at http://www.clevelandclinic.org/face.)

This is the largest and most complex face transplant in the world, integrating different functional components such as nose and lower eyelids, as well as different tissue types including, skin, muscles, bony structures, arteries, veins and nerves.

"This work demonstrates the Cleveland Clinic's commitment to improving the lives of patients through innovation," said Delos M. "Toby" Cosgrove, M.D., President and CEO, Cleveland Clinic. "By advancing scientific research in microsurgery and transplantation, Cleveland Clinic is setting new standards of care. I'm extremely proud of the team who worked tirelessly to make a difference in this patient's life."

The transplant team was led by Maria Siemionow, M.D., Ph.D., Director of Plastic Surgery Research and Head of Microsurgery Training, who received worldwide attention in November 2004 when the Clinic's Institutional Review Board (IRB) announced that face transplantation is both ethical and possible by approving the first protocol for the surgery. Siemionow, a highly regarded scientist, has dedicated her professional life to researching and developing the methods doctors could use to substantially help patients with severe facial disfiguration.

"As a physician, one of the most rewarding things we can do is to restore the quality of life to a patient," said Siemionow (pronounced "SEMM-ih-nof"). "Patients with facial disfigurement have very difficult challenges in society. We hope that one day we may be able to help the tens of thousands of patients who are quietly suffering."

Frank A. Papay, M.D., Chairman of the Dermatology and Plastic Surgery Institute, said the surgery was made possible because of the multi-disciplinary team involved. "This work started with a medical team that had an extraordinary vision for what could be possible for patients who have suffered severe trauma to their faces. Cleveland Clinic's team has worked together to take that vision and make it a reality," Papay said. "In the end, we're all here for our patients to make their lives better."

Cleveland Clinic Dermatology and Plastic Surgery Institute led the face transplant surgery, partnering with the Cleveland Clinic Head & Neck Institute. Staff members from psychology/psychiatry, bioethics, social work, anesthesia, transplant, nursing, infectious disease, dentistry, ophthalmology, pharmacy, environmental services and security were also significantly involved.

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Opinion: The Quest for Youth, Beauty and... Cancer?

As I was walking on the treadmill this morning I listened to a health segment showing on Fox News. It was not good news gals! There's a new study out that shows a strong link between occurrences of breast cancer and those lotions we use to keep ourselves looking younger... Click to read: Opinion: The Quest for Youth, Beauty and... Cancer?

CeloNova BioSciences Receives FDA Market Approval for Embozene(TM) Color-Advanced Microspheres Embolization Platform

/PRNewswire/ -- CeloNova BioSciences, Inc., announced December 16 that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for Embozene(TM) Color-Advanced Microspheres which are indicated for the treatment of hypervascularized tumors (tumors with a large number of blood vessels in many locations) and arteriovenous malformations (defects in the circulatory system). U.S. commercial sales of Embozene(TM) Microspheres will begin immediately.

Embozene(TM) Microspheres are the first and only microspheres to be color- enhanced with a different color for each size for increased procedural safety, efficiency and visibility. They are also available in a wider range of sizes than any other spherical embolic on the market. They are available in 40 micrometers, 100 micrometers, 250 micrometers, 400 micrometers, 500 micrometers, 700 micrometers, and 900 micrometers sizes in 1 ml and 2 ml pre-filled syringes and vials. CeloNova plans to submit a supplemental 510(k) to the FDA to add three additional sizes, 75 micrometers, 1100 micrometers and 1300 micrometers, for a total of ten sizes including the smallest and the largest microspheres available for endovascular therapy. CeloNova is the only Company that provides this complete range of products.

CeloNova's Embozene(TM) Microspheres consist of a hydrogel core and an exterior shell made from Polyzene(R)-F, CeloNova's proprietary polymer which is known to be anti-inflammatory and bacterial-resistant. Four design features distinguish Embozene(TM) Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability. Embozene(TM) Microspheres are precisely calibrated, they retain their shape after passing through a catheter, and they can stay in suspension for an extended time. The unique color enhancement of the microspheres and finely calibrated sizes make selection easy, efficient, and precise for the operator. The result is an embolic microsphere that provides accurate and complete vessel occlusion.

Embolization is a minimally invasive procedure used to control or prevent abnormal bleeding, to shrink tumors by blocking the blood vessels that supply them, and to block off blood vessel malformations. Physicians use enhanced imaging techniques to visualize the blood vessel, then insert and advance a catheter to the treatment site. The embolic agent is then released into the catheter and positioned within the blood vessel or malformation to block the target vessel permanently.

"Embozene Microspheres are an innovative advance in embolic technology that has been well received outside the U.S.," said John C. Lipman, MD, FSIR, Founder and CEO of the Atlanta Interventional Institute and Director of the Center for Image-Guided Medicine at Emory-Adventist Hospital Atlanta. "Intuitively, a polymer that is anti-inflammatory and that provides more finely calibrated bead sizes, shape integrity, prolonged suspension, and has a unique color-coded selection system that makes for more efficient procedures, will appeal to physicians as well as patients. Embozene(TM) Microspheres maintain suspension better than any other embolic I've seen," said Dr. Lipman. "I'm looking forward to using this therapy in my practice."

"From the outset, we took a different approach to developing our Embozene(TM) Microspheres by asking physicians and medical scientists for the qualities and characteristics that the ideal embolic device should have," said Thomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences, Inc. "Then, we engineered Embozene(TM) Microspheres to have those properties, which are made even better with Polyzene(R)-F, our proprietary polymer. Polyzene(R)-F helps make our leading-edge technology better."

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Piedmont Physicians at Jasper Welcomes Dr. Jayasri Mallavarapu

Piedmont Physicians at Jasper welcomed Jayasri Mallavarapu, M.D., to its healthcare team on Dec. 15. She joins John Aicher, M.D., Nance Karr, F.N.P., and Kathryn Brady, P.A.

Dr. Mallavarapu obtained her medical degree from Osmania University in India, followed by a Masters of Public Health from Emory University in Atlanta. She then completed her medical residency at Floyd Medical Center in Rome, Ga.

Dr. Mallavarapu is a member of the American Medical Association, the American Academy of Family Physicians and the American College of Healthcare Executives.

“Dr. Mallavarapu has years of experience in the medical field, and will provide outstanding services and care for our patients,” said Berney Crane, CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group.

Dr. Mallavarapu accepts most major insurance plans and offers same day appointments. The office is located at 14 Sammy McGhee Boulevard, Suite 204, in Jasper, Ga. Office hours are Monday through Friday, 8 a.m. to 5 p.m. for appointments and walk-in clinic hours are Monday through Thursday 5:30 p.m. to 9 p.m. To schedule an appointment please call 706-253-3141 or for more information visit www.piedmontphysicians.org.
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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.



-- Online : www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

-- Fax: (800) FDA-0178

-- Phone: (800) FDA-1088

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Santa Hosts Piedmont Mountainside Hospital's Love Light Ceremony

More than 75 area residents welcomed Santa to Piedmont Mountainside Hospital's (PMH) annual Love Light Tree Ceremony. PMH Interim CEO Mike Robertson and Auxiliary President Margo Coleman, gave a warm welcome to the guests, who were enjoying the spirit of the season with hot chocolate and cookies.

Santa Claus had the honor of lighting the Christmas tree while the Piedmont Mountainside Employee Ensemble and the First Baptist Church of Jasper Preschool Choir sang delightful carols. Children were able to have their picture taken with Santa, courtesy of Jasper Drugs.

The Love Light Tree, an annual fundraiser sponsored by the PMH Auxiliary, displays Love Lights and Star Lights purchased in honor or memory of family members, friends, or loved ones. The monies raised will go to the new cardiac rehab center. Jasper area residents and the surrounding communities can purchase Love Lights and Star Lights through December 31 at the Hospital gift shop and Moore Furniture on North Main Street.

The Love Light is available for purchase in the amount of $7.00, while the Star Light is on sale for $25.00. For more information, please call 706-692-2441.
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Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful

A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.

The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.

"The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals."

CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.

"We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution," said Woodcock.

In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study's findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.

The FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, but the agency does not review or approve CMI leaflets. The agency's role, as set forth by Congress, has been to encourage the private sector to provide this information, supply the companies with the necessary guidance and evaluate the private sector's progress.

The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy. Shoppers trained to simulate patients visited pharmacies randomly selected throughout the United States. The shoppers gave the pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. Expert and consumer panels evaluated the quantity and quality of this information.

There were some improvements shown by the new study when compared to a similar evaluation of CMI in 2001, Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001. That study revealed that 89 percent of patients received written information when their new prescriptions were filled, but only about 50 percent of the CMI met minimal criteria for usefulness.

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FDA Announces Class I Recalls of Two Unapproved Devices

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
Vibrational Integrated Bio-photonic Energizer device

On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency's November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.

VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.

The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.
HLX8 device

In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.

Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.

Nebion's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.

Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.

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Atlanta Hospitality House Invites All to Join its Annual Angel Network

Who: The Atlanta Hospitality House which provides food, lodging and “a home away from home” for the families of many individuals hospitalized in the Atlanta area.

What: Requesting donations of $25 or more for their annual Angel Tree to be hung at the Atlanta Hospitality House and Emory University Hospital.

When: Throughout the month of December.

Where to Donate: Online at www.atlhhh.org or call 404-377-6333 for more information.

Why: This small donation helps support thousands of guests who care for family members being treated in one of 17 Atlanta area hospitals.

The Atlanta Hospital Hospitality House, a 501(c)3, non-profit organization, believes in the improvement of health and welfare by providing lodging, meals and a “home away from home” for traveling families of inpatients receiving medical treatment at any of the 17 Atlanta regional medical facilities. As the only hospitality house in the Atlanta area, which serves anyone with a need regardless of medical facility or medical issue, the AHHH has catered to over 100,000 guests from all 50 states and 39 foreign countries since 1981. At the AHHH, families can enjoy a safe, quiet and caring environment that focuses on the individual needs of each guest while bringing together families experiencing similar situations. Beginning spring 2009 the newly renovated Home Depot Marcus Hospitality Cottage will house an additional 4 bedrooms for patients of the Marcus Autism Center. For more information, visit www.atlhhh.org.
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Mayo Researchers Find Potential Links Between Breast Density and Breast Cancer Risk

Having dense breasts - areas that show up light on a mammogram - is strongly associated with increased breast cancer risk, but "why" remains to be answered. Now, by examining dense and non-dense tissue taken from the breasts of healthy volunteers, researchers from Mayo Clinic have found several potential links.

In two studies being presented simultaneously in poster form at the Cancer Therapy & Research Center-American Association for Cancer Research (CTRC-AACR) San Antonio Breast Cancer Symposium, the researchers report that dense breast tissue contains more cells believed to give rise to breast cancer, compared to non-dense tissue. "We found a dramatic difference in tissue composition between dense and non-dense tissue in the breast," says Karthik Ghosh, M.D., a Mayo Clinic breast cancer researcher and physician who led one study.

In a second study, researchers also found that dense breast tissue has more aromatase enzyme than non-dense tissue. This is significant because aromatase helps convert androgen hormones into estrogen, and estrogen is important in breast cancer development, says that study's lead investigator, Celine Vachon, Ph.D.

"If aromatase is differentially expressed in dense and non-dense breast tissue, this could provide one mechanism by which density may increase breast cancer risk," Dr. Vachon says.

The researchers say these findings are unique because these studies are the first to examine areas of both dense and non-dense tissue taken from the same breast in healthy volunteers. Examination of healthy women is important, Dr. Ghosh says, because most prior studies of breast density have looked at tissue taken from women with known breast disease.

Sixty women, age 40 to 85, allowed Mayo Clinic researchers to take eight core-needle biopsies from their breasts; none had a history of breast cancer.

Dr. Ghosh and her team examined the biopsies to determine the percentage of epithelium tissue, stroma, and fat content in each. The epithelium is primarily composed of milk glands and ductal cells, and stroma is the connective tissue that supports epithelial cells. Dr. Vachon and her colleagues looked at aromatase expression within cells in both dense and non-dense tissue.

Results are now available from more than half of the participants who donated biopsy tissue. Dr. Ghosh found that areas of density contained much more epithelium (6 percent) and stroma (64 percent) and much less fat (30 percent), compared to non-dense tissue that contained less than 1 percent epithelium, about 20 percent stroma, and almost 80 percent fat. "This shows us that both the epithelium and stroma contribute to density, and suggests that the large difference in stroma content in dense breast tissue may play a significant role in breast cancer risk," Dr. Ghosh says.

She also looked at lobular involution, a decrease in the size and number of milk ducts that has been associated with decreased breast cancer risk, and found that 85 percent of non-dense tissue had complete involution compared to 35 percent of dense tissue.

Dr. Vachon and her team examined expression of aromatase in the biopsy samples and found that the stromal cells in dense breast tissue had more aromatase and intensity of expression in dense tissue, compared to non-dense. They say these findings may help explain why women with greater proportion of dense breast tissue are at greater risk for breast cancer than women with little or no density.

"These are initial findings from one of the first attempts to study breast density at the level of healthy tissue. It doesn't explain everything yet, but is providing really valuable insights," says Dr. Ghosh, who established the patient resource for both studies.

Drs. Ghosh and Vachon are finishing their analysis of the initial 60 volunteers, and they are also enrolling more participants in order to validate and expand their findings. "No one knows why density increases breast cancer risk, but we are attempting to connect the dots," Dr. Vachon says.

These studies were funded by the Mayo Clinic Breast Cancer Specialized Programs of Research Excellence (SPORE) grant, and a National Institutes of Health (NIH) career development award.
The 2008 San Antonio Breast Cancer Symposium (SABCS) is the first Symposium presented by the CTRC, AACR, and the Baylor College of Medicine. The driving force behind the new collaboration is the shared mission of the organizations to advance progress against breast cancer. By combining their respective strengths, the 2008 San Antonio Breast Cancer Symposium will encompass the full spectrum of breast cancer research and facilitate the rapid transition of new knowledge into improved care for breast cancer patients.
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Prescription Drug Benefits for Medicare Patients with Cancer to Cost More in 2009

/PRNewswire-USNewswire/ -- People with cancer enrolled in Medicare Part D plans will spend more out-of-pocket for their Part D drugs and face increased restrictions on access to them in 2009, according to new research released today by Avalere Health and the American Cancer Society Cancer Action Network (ACS CAN).

The Avalere-ACS CAN research found that Medicare stand-alone prescription drug plans (PDPs) have been increasingly shifting name-brand oral cancer drugs to higher formulary tiers over the last four years, meaning that with each year, the products have cost more for consumers.

In 2009, the large majority of PDPs placed name-brand oral oncology products -- including Gleevec, Sutent, Tarceva, Thalomid, and Tykerb -- on specialty tiers that require cost sharing of 26 percent to 35 percent for each prescription. For example, 84 percent of PDP enrollees are in plans that put Gleevec -- a name-brand drug used to treat leukemia and other forms of cancer -- on their most expensive tiers (fourth or higher) in 2009, up from 39 percent in 2006.

"This pattern of shifting the costs of branded medications to patients needs to be scrutinized, especially in light of the economic difficulty being experienced by so many seniors," said Valerie Barton, a vice president at Avalere Health.

"Shifts in drug coverage can limit access to treatment for people with cancer, significantly reducing their treatment options or even requiring a stoppage of treatment," said Daniel E. Smith, president of ACS CAN. "We urge policymakers to pay close attention to how these changes impact people with cancer. At the same time, it is critical that people with cancer understand their health coverage and the potential hurdles that may impact their treatment."

In addition to changing tier placement, PDPs in 2009 are increasing their use of prior authorization to control access to branded cancer drugs. The Avalere-ACS CAN research found that Gleevec had the largest increase in the number of PDPs requiring prior authorization, with 70 percent of plans requiring it, up from 35 percent in 2006. Tarceva had the next highest increase, with 62 percent of plans requiring prior authorization in 2009, up from 35 percent in 2006. Thalomid was next, with 68 percent of plans requiring prior authorization in 2009, up from 43 percent in 2006.

Geography and plan choice influence how much a person with cancer will spend out-of-pocket in Medicare Part D. Avalere and ACS CAN modeled hypothetical drug regimens for women with breast cancer and found that total out-of-pocket costs for a woman enrolled in AARP MedicareRx Saver in Florida will be about $1,985, while total out-of-pocket costs for beneficiaries enrolled in Humana PDP Standard in California will average about $2,551.

ACS CAN and the American Cancer Society are closely monitoring these issues as part of their nationwide efforts to ensure access to quality, affordable health care for all Americans. The organizations believe that the health care system needs to be retooled with an emphasis on prevention and early detection; meaningful health insurance that is adequate, affordable, available and administratively simple; and reducing pain and suffering with an emphasis on quality of life.

Avalere continues to analyze Medicare drug benefit data. Since the inception of the Medicare drug program, Avalere has used its proprietary DataFrame(R) database to track trends in drug pricing, plan strategy and structure, and the beneficiary experience.

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FDA Advisory Committee Votes Unanimously that FC2 Female Condom(R) is Approvable

/PRNewswire-FirstCall/ -- The Female Health Company (NYSE Alternext: FHC) has announced that the U.S. Food and Drug Administration's (FDA) Obstetrics and Gynecology Devices Advisory Committee has unanimously voted that the company's second-generation female condom, the FC2 Female Condom(R), is approvable with a single condition.

The Advisory Committee voted 15-0 that the product is approvable with the condition that the FC2 Female Condom's instructions for use continue to follow use instructions for the FC Female Condom(R) (FC1 Female Condom) and appropriately identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.

The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.

"We are very pleased with today's outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom," said Dr. Mary Ann Leeper, FHC's Senior Strategic Advisor. "We believe that FHC's second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method."

The company filed the FC2 Female Condom Pre-market Approval Application (PMA) with the FDA on January 7, 2008 and has been working with FDA as it reviewed the application.

The company's first-generation FC1 Female Condom received FDA approval for distribution in the United States in 1993. The FC1 Female Condom is also included in the World Health Organization's (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 Female Condoms have been distributed in 142 countries.

The FC2 Female Condom data has been reviewed by other public agencies, including the European Union, India, Brazil and the World Health Organization (WHO). In 2006, the WHO agreed that the FC2 Female Condom does perform in the same manner as the FC1 Female Condom and recommended that the FC2 Female Condom can be purchased by UN agencies. Since then, over 22 million FC2 female condoms have been distributed in 77 countries.

Performance of FC2 Female Condom in Clinical Trial

FHC presented data from a randomized, double-blind, crossover, comparative trial with the FC1 Female Condom. The FC1 Female Condom is currently distributed in over 100 countries, including the U.S. The FC2 Female Condom, which looks very similar to the FC1 Female Condom, was developed to expand access to women at risk of HIV and STIs by lowering the cost of the product through the introduction of a more efficient manufacturing process. The clinical trial was conducted in 2004 by the Reproductive Health and HIV Research Unit of the University of Witwatersrand in South Africa. Over 200 women participated in the study. The results of the study showed that the FC2 Female Condom is safe and that the risk of failure during use was equivalent to FC1. Results from the study were originally published in the journal Contraception. (See Contraception 73 (2006) 386- 393.)

Unintended Pregnancy and HIV/STI Transmission in the U.S.

Unintended pregnancy and the transmission of HIV and other STIs remain significant public health challenges in the U.S. According to the Centers for Disease Control and Prevention (CDC), approximately one-half of pregnancies in the U.S. were unintended in 2001, and contraception methods provided by federally funded family planning programs (male condoms, female condoms, the Pill, and IUDs) prevent an estimated 1.3 million unintended pregnancies each year.

Over the past two decades, the proportion of women among all people living with HIV/AIDS (PLHIV) in the U.S. has more than tripled -- from 8 percent of PLHIV in 1985 to 26 percent in 2007. HIV infection has emerged as the leading cause of death for African American women aged 25-34, high-risk heterosexual contact is responsible for 80 percent of new HIV infections among American women, and one in four young adults aged 15-20 years contracts a sexually transmitted infection each year.

In this context, expanded access to the female condom -- the only safe, effective, and available woman-initiated prevention method currently available -- can provide women and men with more options to practice safer sex and prevent unintended pregnancy.


"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

The statements in this release which are not historical fact are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release may be identified by the use of forward-looking words or phrases such as "anticipate," "believe," "could," "expect," "intend," "may," "planned," "potential," "should," "will," "would" or the negative of those terms or other words of similar meaning. These statements are based upon the Company's current plans and strategies, and reflect the Company's current assessment of the risks and uncertainties related to its business, and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company's actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; the Company's reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity; efficiency and supply constraints; and other risks detailed in the Company's press releases, shareholder communication and Securities and Exchange Commission filings, including the Company's Form 10-KSB for the fiscal year ended September 30, 2007. Actual events affecting the Company and the impact of such events on the Company's operations may vary from those currently anticipated.

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FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury

Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures.

The FDA has also directed the manufacturer of these products to develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with the use of these products.

The agency is equally concerned about the risks associated with the use of OSP products that are available over-the-counter (OTC), for example, Fleet Phospho-soda, when used at higher doses for bowel cleansing. The available data do not show a risk of acute kidney injury when these OTC products are used at the lower doses for laxative use. However, when used for bowel cleansing, these products have the same risks as prescription OSP products. FDA plans to amend the labeling conditions for OTC OSP products to address this concern with bowel cleansing use. In light of the continued receipt of reports of acute phosphate nephropathy, FDA is recommending that consumers not use over-the-counter OSPs for bowel cleansing.

“Though rare, these are serious adverse events associated with the use of oral sodium phosphates -- both prescription and over-the-counter products,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.”

In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of OSP products for bowel cleansing. Since then, as part of the Agency’s postmarketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep. Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use.

OSP products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate. FDA is recommending that OSP prescription products be used with caution for bowel cleansing by the following at risk groups:

* people over 55 years of age,
* people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
*
people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
and mail to:
MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

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