FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
--Online
--Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

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Process Begins to Define "Meaningful Use" of Electronic Health Records

Building on the historic $19 billion investment provided through the
American Recovery and Reinvestment Act of 2009 (Recovery Act), efforts
continued today to further the national adoption and implementation of
health information technology (HIT) -- an essential tool to modernize
the health care system and bring about improved health for all
Americans. The Health Information Technology (HIT) Policy Committee, a
Federal Advisory Committee (FACA) to the U.S. Department of Health and
Human Services (HHS), met today to begin the process of defining
"meaningful use" of electronic health records (EHRs). This meeting is a
first step for the department, as it investigates possible definitions
for meaningful use.

"We are moving fast to achieve the President's goal to improve the
health and well-being of every American through the on-going use of
health information technology," stated HHS' National Coordinator for
Health Information Technology David Blumenthal, M.D., M.P.P. "The work
of the policy committee is a first step toward assuring that technology
-- the electronic health record -- is used in a meaningful way to
provide better patient care."

The Recovery Act provides Medicare and Medicaid incentive payments to
eligible providers, such as physicians and hospitals, in order to
increase the adoption of EHRs. To receive the incentive payments,
providers must demonstrate "meaningful use" of a certified EHR.
Building upon the work done by the HIT Policy Committee, the Centers for
Medicare & Medicaid Services (CMS), along with the Office of the
National Coordinator for Health Information Technology (ONC), will be
developing a proposed rule that provides greater detail on the incentive
program and proposes a definition of meaningful use. CMS expects to
issue the proposed rule in late 2009, which will be followed by a
comment period.

The recommendations discussed today represent extensive work by the
Committee's Meaningful Use Workgroup to review and evaluate diverse
ideas and contributions from Workgroup members along with information
from a public hearing on meaningful use convened in April by the
National Committee on Vital and Health Statistics (NCVHS). The NCVHS
hearing brought together key healthcare and information technology
stakeholder groups. The workgroup also reviewed written comments from
additional diverse stakeholders.

A public comment period on today's recommendations will be open through
the close of business on Friday, June 26, 2009. Instructions on how to
submit public comment can be found at http://healthit.hhs.gov.

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CSTE Leads Effort to Improve Blood Lead Reporting

/PRNewswire / -- Citing evidence that even a very low level of blood lead is a significant health risk at any age, the Council of State and Territorial Epidemiologists (CSTE) is recommending a change in the case definition of elevated blood lead levels in adults. In a vote at the CSTE annual conference in Buffalo, NY, State Epidemiologists approved a proposal to consider blood levels of 10 ug/dl or more in adults as "elevated" -- the same standard as currently exists for children.

Studies show that blood lead levels as low as 10 ug/dl contribute to an elevation in blood pressure and attendant health risks, including stroke. Low blood levels also are associated with an increase in mortality from heart disease, decreased kidney function and changes in cognition.

"Having this additional data will allow researchers, epidemiologists and the public to know more about the burden of lead poisoning across the age spectrum," CSTE President Mel Kohn, M.D., M.D.H. said. "While we often think of lead poisoning as a health concern in children and pregnant women, we need to address how lead poisoning is affecting adults, from exposure in the workplace and from hobbies such as target shooting."

The risk of lead poisoning is especially pronounced among workers in certain industries, including lead refining and smelting; construction work involving paint removal; manufacture of bronze and brass products such as plumbing fixtures; demolition and maintenance of outdoor metal structures such as bridges and water towers; and battery manufacturing and recycling.

Many occupational exposures are not identified because not all employers do the required occupational testing. Compounding the problem is the fact that only a fraction of known occupational cases are included in national health statistics, which currently only include counts of individuals with blood lead levels 25 ug/dl and greater.

Some states are already obtaining reports from laboratories of individuals with blood lead levels lower than 25 ug/dl and share this information with the Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health Adult Blood Lead and Epidemiology (ABLES) Program. ABLES received reports of 12,935 adults with blood lead levels from 10-24 ug/dl who were tested in 2007 in 21 states, compared to reports of 5,419 adults with blood lead levels of 25 ug/dl and above in these same states. These reports are likely minimum estimates of the true magnitude of the problem.

"The current ABLES data for adults with blood lead levels of less than 25 ug/dl reflects only sporadic reporting," Dr. Kohn said. "The result is a significant underestimation of the health impact of elevated blood lead levels in the population of the United States that will be greatly alleviated by the new recommended reporting practices. With more complete reporting, we will have a clearer picture of the true scope of the problem to guide our efforts to prevent lead poisoning. This will reduce the toll of lead exposure on the health of Americans of all ages."

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FDA Requests Labeling Change for Leukotriene Modifiers

The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen. Montelukast and zafirlukast are leukotriene receptor antagonists that work by blocking leukotrienes. Zileuton is a leukotriene synthesis inhibitor which works by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

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The Secret Lives of Sneezes and Coughs

Like people, coughs come in all shapes and sizes. They can be deep or shallow, long or short, or forced or stifled. Scientists who study the ways we cough and sneeze are shedding light on how viruses like influenza spread.

To follow the evolution of cough, scientists use elaborate setups that reveal how much saliva is expelled and where it goes. They ask people to cough into masks that are carefully weighed before and after the coughs. They illuminate the flows of coughs with powerful lasers and fancy photo techniques and use powerful computers to model this flow of thousands of tiny particles. They use heated manikins and cough machines in rooms filled with tiny droplets of olive oil or theatrical smoke to track how air moves, where breath goes, and how exposed we are to someone else's cough.

A typical cough starts with a deep breath, followed by a compression of air in the lungs and then a crackling burst as that air is forced out in a fraction of a second. The average human cough would fill about three-quarters of a two-liter soda bottle with air -- air that shoots out of the lungs in a jet several feet long. Coughs also force out thousands of tiny droplets of saliva. About 3,000 droplets are expelled in a single cough, and some of them fly out of the mouth at speeds of up to 50 miles per hour.

Sneezing is even worse. It starts at the back of the throat and produces even more droplets -- as many as 40,000 -- some of which rocket out at speeds greater than 200 miles per hour. The vast majority of the droplets are less than 100 microns across -- the width of a human hair. Many of them are so tiny that they cannot be seen with the naked eye.

"What happens to these droplets depends on their size," said fluid dynamicist Bakhtier Farouk of Drexel University in Philadelphia. He is working on software that models how microscopic droplets move around a room.

Most of the larger, heavier drops fall quickly to the floor under the influence of gravity. The smaller and lighter particles (those that are five microns or less across) are less affected by gravity and can stay airborne almost indefinitely as they are caught up in and dispersed by the room's airflow.

Movements in a room can cause the heavier droplets to become airborne again after they have fallen to the ground or another surface. Making a hospital bed can kick up viruses on the covers. Opening a door can dramatically alter the airflow in the room and pull up viruses on the floor. Even walking through a room can spread droplets in a person's wake.

If a person is sick, the droplets in a single cough may contain as many as two hundred million individual virus particles. The number varies dramatically and changes over the course of an infection as the immune system clears out the virus. Generally, a sick person is most infectious as soon as the first symptoms appear and less infectious as his or her immune system clears the virus.

Once airborne, viruses in these tiny droplets can survive for hours. Even if the droplets hit a surface, the viruses can survive and still spread disease if the droplets become airborne later. When a droplet lands on paper, its virus particles can survive for hours. On steel or plastic they can survive for days.

Once they are breathed in, the droplets settle onto cells at the back of the throat, where the virus attempts to enter these cells and begin replicating. This may or may not cause an infection. The body's natural defenses are designed to eliminate infections, and whether someone will fall ill depends on how much virus is breathed in and whether the person's immune system has encountered that virus previously, said Julian Tang, a clinical virologist in Singapore.

When people do get sick, the body tries to deal with the infection by bringing up mucus to help clear it. Some of this mucus is swallowed, carrying the virus down to be destroyed by stomach acid. Some viruses in the throat, though, will be expelled when we cough, and this coughing expels the mucus (and new virus) out of the body, thus beginning the whole process anew.

By Jason Socrates Bardi
Inside Science News Service

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FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.
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FDA Alerts Patients to Medtronic Pacemaker Recall

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

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FDA Approves Injectable Form of Ibuprofen

The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn.

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Minorities, Low Income Americans More Likely to Be Sick, Less Likely to Get Care

U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius yesterday released a new report on health disparities in America and participated in a White House Health Care Stakeholder Discussion on the importance of reform that reduces disparities that exist in our current health care system. The new report Health Disparities: A Case for Closing the Gap is
available at www.HealthReform.gov.

"Minorities and low income Americans are more likely to be sick and less likely to get the care they need," Secretary Sebelius said. "These disparities have plagued our health system and our country for too long. Now, it's time for Democrats and Republicans to come together to pass
reforms this year that help reduce disparities and give all Americans the care they need and deserve."

A Case for Closing the Gap highlights some of the glaring disparities that exist in the current health system. Under the status quo:

- Forty-eight percent of all African Americans adults suffer from
a chronic disease compared to 39 percent of the general population.
- Eight percent of white Americans develop diabetes while 15
percent of African Americans, 14 percent of Hispanics, and 18 percent of
American Indians develop diabetes.
-Hispanics were one-third less likely to be counseled on obesity
than were whites -- only 44 percent of Hispanics received counseling.
- African Americans are 15 percent more likely to be obese than
whites.

The report also notes that 40 percent of low-income Americans do not have health insurance. About one-third of the uninsured have a chronic disease, and they are six times less likely to receive care for a health problem than the insured. In contrast, only 6 percent of high-income
Americans lack insurance.

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FDA Requires Boxed Warning for All Botulinum Toxin Products

Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.

The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.

“Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks.”

Product Names

The products required to add the new label and a REMS are Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.

Botox, Myobloc, and Dysport are approved by the FDA for the treatment of a condition marked by repetitive contraction of the neck muscles (cervical dystonia). Botox Cosmetic and Dysport are approved by the FDA for dermatologic use in the temporary improvement in the appearance of frown lines between the eyebrows called glabellar lines. In addition, Botox is approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).

Recommendations for Health Care Professionals

The FDA has notified the manufacturers of Botox and Myobloc that label changes and a REMS are necessary to ensure that the benefits of the product outweigh the risks. The FDA approved a REMS for Dysport as part of the product approval. The REMS for each of these products will include a Medication Guide and a Communication Plan. Medication Guides are FDA-approved handouts given to patients, or their families and caregivers, when a medicine is dispensed. The Medication Guides will contain information about the risks associated with botulinum toxin products. The FDA is also requiring the manufacturers to collect safety data in children and adults with muscle spasticity to assess the signal of risk regarding distant spread of toxin effects.

Treatment of muscle spasticity is not an FDA-approved use of botulism toxin products. The doses used in treatment of muscle spasticity are often much higher than the doses for uses described in FDA-approved product label. Symptoms consistent with spread of toxin effects have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label.

The companies that make Botox and Myobloc are required to submit the requested safety label changes, including the boxed warning and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions the agency is allowed to issue an order directing the label change as deemed appropriate to address the new safety information.

Health care professionals who use botulinum toxins should do the following:

Understand that dosage strength (potency) expressed in “Units” is different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one product to another.

Be alert to and educate patients and caregivers about the potential for effects following administration of botulinum toxins such as: unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
Understand that these effects have been reported as early as several hours and as late as several weeks after treatment.

Advise patients to seek immediate medical attention if they develop any of these symptoms.
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 --Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787--Fax: 800-FDA-0178--Phone: 800-FDA-1088

Today’s action updates a February 2008 announcement that the FDA was conducting an ongoing safety review of botulinum toxin products.The FDA also issued a response to a citizen petition related to the risk of spread of botulinum toxin effects from the site of injection. This response provides additional detail regarding the FDA’s analysis of this safety issue. The FDA’s response to the Citizen Petition can be found at http://www.fda.gov/cder/drug/early_comm/botulinum_CP_response.pdf
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Rep. Lewis Commends Kidney Care Partners' Health Care Campaign to Improve Survival Rates of First-Year Dialysis Patients in Georgia

/PRNewswire / -- Kidney Care Partners announced the launch of a voluntary quality improvement campaign pledging to reduce mortality among first-year dialysis patients - those at the greatest risk - in Georgia and across the country by 20 percent by the end of 2012.

The "Performance Excellence and Accountability in Kidney Care" or PEAK Campaign (www.kidneycarequality.org) to reduce mortality in the first year will focus on patient education and key clinical care activities to achieve its goal.

Led by Kidney Care Partners, with support from research partners at Brown University and Quality Partners of Rhode Island as well as experts in the kidney community, the PEAK Campaign will:

-- Equip health care providers with tools to help first-year dialysis
patients better transition;
-- Improve the health and survival of first-year dialysis patients;
-- Result in reduced hospitalizations, thus resulting in Medicare
savings.


The PEAK campaign has garnered support not only from a broad cross-section of the kidney community but also from policymakers. "This Congress is deeply committed to resolving the fundamental challenges of health care delivery in this country, but we cannot do it alone," said Rep. John Lewis (D-GA), sponsor of the Kidney Care Quality and Education Act of 2007, which included patient-centered education programs and linked reimbursement with quality care - provisions which were ultimately passed as part of the Medicare legislation of 2008. "We need organizations like KCP to target specific problem areas in the community and find ways to respond. Saving lives is the goal that motivates us all."

Kidney disease affects more than 26 million people nationwide. Approximately 400,000 Americans suffer from kidney failure and require dialysis or kidney transplantation to survive. Transplants are limited due to the shortage of donor organs, so most patients undergo dialysis for three to four hours, three times a week. The number of Americans with kidney disease is rising steadily due to risk factors including diabetes, hypertension, obesity and high blood pressure.

African Americans, Hispanics and other minority groups are most at-risk for developing kidney failure. And while African Americans make up just 12 percent of the general population, they account for 30 percent of people with kidney failure.

There were 3,790 new dialysis patients in 2007 in Georgia alone, a 15 percent increase since 2003, and a total of 14,086 patients on dialysis in 2007 in Georgia, a more than 20 percent increase since 2003, according to the Southeastern Kidney Council.

All too often, the onset of chronic kidney disease (CKD) is gradual and undetected, leaving patients especially vulnerable when the disease is recognized. Helping patients to understand their disease and to manage it appropriately is an essential ingredient to high quality care for newly diagnosed patients and a central component of the PEAK Campaign.

"The kidney care community has achieved considerable and measurable quality improvements in the last decade. The goal of the PEAK Campaign is to help us achieve comparable results in the next decade," said Kent Thiry, KCP Chair. "Our Campaign focuses on patients who are new to dialysis, because these patients are particularly vulnerable. One challenge is to help these patients understand and effectively manage their disease. We also will start a systematic community-wide process of identifying and sharing 'breakthrough' practices that will improve survival rates."

While the survival rate of end-stage renal disease (ESRD) patients has improved, mortality in the first year of dialysis has remained stable during the last decade. The kidney care community has recognized the need to improve the first-year mortality rate as compared to other industrialized nations.

With recommendations from our research partners, KCP will encourage providers to further improve outcomes for first-year dialysis patients in an effort to extend, even save, 10,000 lives.

"Dialysis providers already have robust quality improvement programs in place to ensure consistent delivery of high quality care. The kidney care community looks forward to undertaking this voluntary effort to take quality improvement to the next level," KCP's Thiry added.

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Three in Every One Thousand U.S. Children Diagnosed with Tourette Syndrome

The first-ever national estimate among a nationally representative sample of U.S. children revealed that 3 out of every 1000 children between the age of 6 and 17 in the United States have been diagnosed with Tourette Syndrome (TS), according to a study by the Centers for Disease Control and Prevention (CDC) released in the Morbidity and Mortality Weekly Report.

The study, “Prevalence of Diagnosed Tourette Syndrome in Children in the United States, 2007,” found that a TS diagnosis is three times more common in boys than in girls, and approximately twice as common in children between 12-17 years as those aged 6-12 years. Among children with TS, 27% were reported as having moderate or severe TS and 79% of children had also been diagnosed with at least one additional mental health or neurodevelopmental condition.

Tourette Syndrome is a neurological disorder that typically begins during early childhood, with symptoms being most severe between the ages of 10 and 12 years. TS is characterized by recurring multiple motor tics and at least one vocal tic. Tics are involuntary, repetitive, stereotyped, usually sudden and rapid movements or vocalizations that may be suppressed for short periods of time.

“TS and tic disorders have been linked to higher rates of Attention Deficit/Hyperactivity Disorder, obsessive-compulsive disorder, and impairments associated with these conditions, such as learning disabilities and problems with peer relations,” said Dr. Rebecca Bitsko, Health Scientist at the Centers for Disease Control and Prevention. “Given the high number of children diagnosed with TS who have another mental health or neurodevelopmental condition, it is necessary to further study the relation between these conditions.”

Further, the data showed that non-Hispanic white children were more than twice as likely as non-Hispanic black children or Hispanic children to have a parent-reported TS diagnosis.

“Having an estimate of the number of U.S. children who are diagnosed with TS is a first step toward understanding the overall impact of this condition in the population,” said Dr. Bitsko. “Further research must examine differences in access to health care for children with TS in different population groups, the impact of TS on the quality of life, long term outcomes for children with TS, and strategies for reducing the impact of conditions associated with TS.”

The study analyzed data from interviews with parents (or guardians) from 91,642 households from April 2007 through July 2008 collected through the National Survey of Children′s Health (NSCH). The NSCH is the first large, national, population-based survey of U.S. children up to 18 years old that included questions on TS. This random-digit-dialed telephone survey is sponsored and directed by the Health Resources and Services Administration′s Maternal and Child Health Bureau and conducted by CDC through the State and Local Area Integrated Telephone Survey program. Interviews were completed in 66.0% of identified households with children which represents a 46.7% response of all possible eligible households.

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Clayton State Honors Students Holding Red Cross Blood Drive on June 15

The Clayton State University Honors Student Association will be holding another Red Cross Blood Drive on Monday, June 15.

The Red Cross Bloodmobile will be located in the parking lot in front of the University’s new Student Activities Center from 10 a.m. to 2 p.m.

For more information, go to www.giveblood.org or email the Honors Student Association’s Jenna Pair at jpair@student.clayton.edu.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.

FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug

The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves' disease.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

PTU was approved for marketing in 1947. A total of 32 cases of serious liver injury associated with the use of PTU were reported to the FDA's Adverse Event Reporting System since that system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant.

Graves’ disease is an autoimmune disorder that leads to overactivity of the thyroid gland. The thyroid gland, located in the front of the neck just below the Adam’s Apple, releases hormones that regulate the rate of the body’s metabolism and are critical for body temperature control, energy, weight, mood, and blood calcium levels.

PTU is considered second-line drug therapy, except in certain patients who are allergic to, or intolerant of, methimazole. Because a rare birth defect has been reported with methimazole and not with PTU, PTU may be more appropriate for patients with Graves’ disease who are in the first trimester of pregnancy.

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Roche Diagnostics notifies customers of the potential for ACCU-CHEK® Softclix 10 and/or 17 count lancets to be uncapped

Roche Diagnostics notifies customers of the potential for ACCU-CHEK® Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick

Roche Diagnostics announced May 18 that it is notifying its customers and healthcare professionals about a potential issue with a small number of ACCUCHEK ® Softclix 10 and/or 17 count lancets that have missing caps that were distributed as samples or in the following meter kits:

Meter Kits	REF Number	Lancet Count	Lancet Lot Numbers Affected
ACCU-CHEK® Active Meter Kit ACCU-CHEK® Voicemate Meter ACCU-CHEK® Aviva Meter kits that include an ACCU-CHEK® Softclix lancing device Coaguchek XS Systems for Patient Self-Testing	03184501001 12030802001 04893247001 04837738001	10	M25C2, M25C5, M25C7, M32B5, N32A5
ACCU-CHEK® Compact Plus Meter Kit	03149137001, 05177294001, 05079241001	17	M25C9, M25D2, M27D6, M32A8, M32B3

Missing caps can lead to the potential for an accidental needle stick. It is for this reason that Roche Diagnostics, in cooperation with the U.S. Food and Drug Administration (FDA), is voluntarily requesting that customers inspect their lancets prior to opening the plastic bag containing the lancets. If customers notice ACCU-CHEK Softclix 10 and/or 17 count lancets without caps do not use them. Additionally, customers should use caution while handling the lancets to avoid the potential for an accidental needle stick, dispose of them in apuncture proof container with a lid, and contact one of the following phone numbers for a replacement:

• Diabetes Care customers: 1-800-778-7057 (ACCU-CHEK Customer Care Service Center)
• CoaguChek customers: 1-800-778-7505 (Point-of-Care Technical Service) Customers should always use caution when handling lancets. Roche takes this issue very seriously and is taking steps to prevent this issue in the future.

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