FDA approves opioid analgesic to help cancer patients manage pain

The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.

“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.

Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs such as the program approved for Abstral. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.

“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”

The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.

Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Abstral is manufactured by ProStraken Inc., based in Bedminister, N.J.

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Study: Starting with Chiropractic Saves 40% on Low Back Pain Care

(BUSINESS WIRE)--A new study finds that low back pain care initiated with a doctor of chiropractic (DC) saves 40% on health care costs when compared with care initiated through a medical doctor (MD), the American Chiropractic Association (ACA) announced today. The study, featuring data from 85,000 Blue Cross Blue Shield beneficiaries, concludes that insurance companies that restrict access to chiropractors for low back pain treatment may inadvertently pay more for care than they would if they removed such restrictions.

Low back pain is a significant public health problem. Up to 85 percent of Americans have back pain at some point in their lives. In addition to its negative effects on employee productivity, back pain treatment accounts for about $50 billion annually in health care costs—making it one of the top 10 most costly conditions treated in the United States.

The study, “Cost of Care for Common Back Pain Conditions Initiated With Chiropractic Doctor vs. Medical Doctor/Doctor of Osteopathy as First Physician: Experience of One Tennessee-Based General Health Insurer,” which is available online and will also be published in the December 2010 issue of the Journal of Manipulative and Physiological Therapeutics, looked at Blue Cross Blue Shield of Tennessee’s intermediate and large group fully insured population over a two-year span. The insured study population had open access to MDs and DCs through self-referral, and there were no limits applied to the number of MD/DC visits allowed and no differences in co-pays.

Results show that paid costs for episodes of care initiated by a DC were almost 40 percent less than care initiated through an MD. After risk-adjusting each patient’s costs, researchers still found significant savings in the chiropractic group. They estimated that allowing DC-initiated episodes of care would have led to an annual cost savings of $2.3 million for Blue Cross Blue Shield of Tennessee.

“As doctors of chiropractic, we know firsthand that our care often helps patients avoid or reduce more costly interventions such as drugs and surgery. This study supports what we see in our practices every day,” said ACA President Rick McMichael, DC. “It also demonstrates the value of chiropractic care at a critical time, when our nation is attempting to reform its health care system and contain runaway costs.”

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Arthritis Impacts African-Americans and Hispanics More than Whites

/PRNewswire/ -- Arthritis causes more pain and limitations for African-Americans and Hispanics than for whites, according to a study released today by the Centers for Disease Control and Prevention.

African-Americans were 17 percent less likely to report having arthritis than whites, and Hispanics were 46 percent less likely to report the condition than whites, the study said. However, African-Americans and Hispanics with arthritis were almost twice as likely to report severe joint pain and work limitations attributed to their arthritis when compared to whites, it said.

The study, "Difference in the Prevalence and Impact of Arthritis among Racial / Ethnic Groups," was published in the journal Preventing Chronic Disease.

Arthritis is the leading cause of disability in the United States, affecting 1 in 5 adults. It interferes with work and other daily activities and can complicate the management of other chronic diseases. Arthritis encompasses more than 100 diseases and conditions that affect joints and other connective tissue.

The reason for the racial and ethnic differences, while unknown, may result from a lack of access to health care, language barriers and cultural differences, the report says.

"We must address these stark differences in arthritis impact by using what we know,'' said Jennifer Hootman, an epidemiologist for the CDC National Center for Chronic Disease Prevention and Health Promotion and co-author of the report. "We can educate those with arthritis about increasing physical activity and self-management and reducing obesity, especially those in groups bearing a disproportionate burden from arthritis."

The data, collected from the CDC National Health Interview Survey, are the first to estimate the national prevalence of arthritis and assess its impact among smaller racial and ethnic groups that are usually grouped together when reporting health statistics.

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FDA Approves New Formulation for OxyContin

The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.

OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate to severe pain for an extended period of time. Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse.

The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended.

“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, M.D., director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research.

“As with all opioids, safety is an important consideration,” he said. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.”

According to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, approximately half a million people used OxyContin non-medically for the first time in 2008.

The manufacturer of OxyContin, Purdue Pharma L.P., will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid. The FDA is also requiring a REMS (Risk Evaluation and Mitigation Strategy) that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.

Purdue Pharma is based in Stamford, Conn.

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Vertebroplasty for Patients With Osteoporosis Provides Effective Pain Relief

/PRNewswire/ -- Patient selection is key for vertebroplasty--a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy--to be effective and successful, according to a study of more than 1,500 persons who were followed over seven years. Additionally, collaboration between an interventional radiologist and other medical experts in treating a patient is imperative, say researchers at the Society of Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

"Vertebroplasty puts lives and vertebrae back together," said Giovanni C. Anselmetti, M.D., interventional radiologist at the Institute for Cancer Research and Treatment in Turin, Italy. Before treatment, many osteoporotic patients are in constant pain and cannot manage everyday activities. Vertebroplasty, a minimally invasive treatment performed by interventional radiologists under imaging guidance, stabilizes collapsed vertebrae with the injection of medical-grade bone cement into the spine. The treatment provides pain relief and improves one's quality of life--if given to appropriately selected candidates in whom conventional medical treatment has failed (such as analgesics or narcotic drugs that provide minimal or no pain release or doses that are intolerable), he further explained. "Our long-term follow-up confirmed this: pain relief and quality of life significantly improved with vertebroplasty," said Anselmetti.

Osteoporosis, the most common type of bone disease, is characterized by low bone mass and structural deterioration of the bone, resulting in an increased susceptibility to fractures. Osteoporosis affects 10 million Americans and is responsible for 700,000 vertebral fractures each year. Multiple vertebral fractures can result in chronic pain and disability, loss of independence, stooped posture and compression of the lungs and stomach.

"Vertebroplasty dramatically improves back pain within hours of the procedure, provides long-term pain relief and has a low complication rate, as demonstrated in multiple studies," said Anselmetti. Vertebroplasty provides pain relief from the complications of osteoporosis (vertebral fractures) but not the disease that caused it (osteoporosis), said Anselmetti. "For the best results, collaboration between physicians is mandatory. All osteoporotic patients need to be followed by an interventional radiologist, who determines which patients are appropriate candidates to receive vertebroplasty treatment, and an experienced medical expert (in this study, a rheumatologist) to ensure continued treatment for osteoporosis," he said.

Anselmetti illustrated a typical case: an 80-year-old Italian woman, who was diagnosed last year with two painful osteoporotic vertebral collapses, underwent medical treatment for osteoporosis (with the drug teriparatide) and was still in pain when she was prescribed an external brace. After there was evidence of two new fractures (verified by MR imaging), she received vertebroplasty, experiencing "complete pain regression, no need for the brace and a dramatic Lazarus-like ability to perform daily activities," he noted.

Researchers studied 2,251 osteoporotic patients (1,811 women; average age, 65) suffering from back-pain for vertebral collapses (MRI confirmed) who underwent a clinical interview; their medical treatment, pain grade, quality of life and extent of vertebral fracture were reviewed. Vertebroplasty was performed in 1,542 patients (1,302 women; average age, 73) when optimal medical treatment (such as biphosphonates, teriparatide, analgesics and back brace) did not help relieve pain or improve quality of life for patients over a three-month period. After vertebroplasty, patients continued to receive medical treatment with a rheumatologist. Because interventional radiologists use high-quality, image-guiding systems (such as digital flat-panel fluoroscopy with built-in rotational image acquisition), treatment time is decreased, making for a safer procedure, added Anselmetti.

In 1,494 patients (96.9 percent), the average pretreatment pain score on the 11-point visual analog scale was 8.2+/-1.8, and it dropped "significantly" to an average of 1.1+/-1.6 after vertebroplasty treatment, said Anselmetti. A patient's ability to manage everyday life--such as washing, dressing or standing--was measured by the commonly used Oswestry Disability Questionnaire, which was completed by patients before and after vertebroplasty. The ODQ scores changed from an average of 68.7+/-7.6 percent to 18.5+/-8.2 percent. Long-term follow-up (average, 31.2 months) in 1,017 patients (857 women; average age, 72) showed the VAS significantly dropping from 7.9+/-1.5 to 1.3+/-1.7. Of the 757 patients wearing a back brace before vertebroplasty, 683 could stop wearing one after treatment.

Anselmetti said that additional studies need to be performed, such as a large randomized trial comparing conventional medical treatment to medical treatment plus vertebroplasty. In Europe, this is difficult, as patients with chronic back pain for vertebral osteoporotic fractures prefer to be treated by vertebroplasty--and not randomized into a medical treatment-only group. "Patients who are in so much pain ask if they can be considered for vertebroplasty treatment," said the co-author of "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience."

More information about the Society of Interventional Radiology, interventional radiologists and vertebroplasty can be found online at www.SIRweb.org.

Abstract 16: "Percutaneous Vertebroplasty (PV) in the Osteoporotic Patients: Optimal Indications and Patient Selection to Improve Clinical Outcome: Personal Experience in 1,542 Patients Over Seven Years' Experience," G.C. Anselmetti, A. Manca, G. Chiara, G. Iussich and D. Regge, all at the Institute for Cancer Research and Treatment, Candiolo, Italy; and G. Isaia, University of Turin, Turin, Italy, SIR 35th Annual Scientific Meeting March 13-18, 2010, Tampa, Fla. This abstract can be found at www.SIRmeeting.org.

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FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

This is the only FDA approved morphine sulfate oral solution available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now.

Today’s action is part of the FDA’s unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough drug available for patients. The FDA will also be working with patient organizations and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” said Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”

One benefit of the FDA approval process is a requirement for manufacturers to provide sufficient information on how to safely prescribe and use a drug. Manufacturers may also have to establish additional safety measures to manage unique risks of a medicine. For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose.

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FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox — the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.

Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.

“This new product can provide effective pain relief for patients who suffer from PHN,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.

Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.

The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.

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GSU researchers explore how pain in infancy can change pain sensitivity in adulthood

Scientists at Georgia State University have uncovered the mechanisms of how pain in infancy alters how the brain processes pain in adulthood.

Research is now indicating that infants who spent time in the neonatal intensive care unit (NICU) show altered pain sensitivity in adolescence. These results have profound implications and highlight the need for pre-emptive and post-operative pain medicine for newborn infants.

The study, published online in the journal Frontiers in Behavioral Neuroscience, sheds light on how the mechanisms of pain are altered after infant injury in a region of the brain called the periaqueductal gray, which is involved in the perception of pain.

Using Sprague-Dawley rats, Jamie LaPrairie, a graduate student in associate professor Anne Murphy’s laboratory, examined why the brief experience of pain at the time of birth permanently decreased pain sensitivity in adulthood.

Endogenous opioid peptides, such as beta-endorphin and enkephalin, function to inhibit pain. They’re also the ‘feel good’ substances that are released following high levels of exercise or love. Since these peptides are released following injury and act like morphine to dampen the experience of pain, LaPrairie and Murphy tested to see if the rats, who were injured at birth, had unusually high levels of endogenous opioids in adulthood.

To test this hypothesis, LaPrairie and Murphy gave adult animals that were injured at the time of birth a drug called naloxone. This drug blocks the actions of endogenous opioids. After animals received an injection of naloxone, they behaved just like an uninjured animal.

The scientists then focused on the periaqueductal gray region to see if inflammation at birth altered the natural opioid protein expression in this brain region. Using a variety of anatomical techniques, the investigators showed that animals that were injured at birth had endogenous opioid levels that were two times higher than normal.

While it’s beneficial to decrease pain sensitivity in some cases, it’s not good to be completely resilient to pain.

“Pain is a warning sign that something is wrong,” Murphy explained. “For example, if your hand is in water that's too hot, pain warns you to remove it before tissue damage occurs.”

Interestingly, while there is an increase in endorphin and enkephalin proteins in adults, there is also a big decrease in the availability of mu and delta opioid receptors. These receptors are necessary in order for pain medications, such as morphine, to work. This means that it takes more pain-relieving medications in order to provide relief as there are fewer available receptors in the brain. Studies in humans are reporting the same phenomenon.

The number of invasive procedures an infant experienced in the NICU is negatively correlated with how responsive the child is to morphine later in life; the more painful procedures an infant experienced, the less effective morphine is in alleviating pain.

The study by LaPrairie and Murphy has major implications for the treatment of infants in neonatal intensive care. On average, a prematurely born infant in a neonatal intensive care unit will experience 14 to 21 invasive procedures a day, including heel lance, insertion of intravenous lines, and intubation. All of these procedures are quite painful and are routinely conducted without prior analgesics or anesthetics.

“It’s imperative that pain be treated,” Murphy said. “We once assumed that a newborn infant is insensitive to pain, and this is clearly not the case. Even at that period of time, the central nervous system is able to respond to pain, and our studies show that the experience of pain completely changes the wiring of the brain in adulthood.”

The next steps in Murphy’s research include the study of how neonatal injury at birth alters stress responses, as well as the affects of infant injury on long-term learning and memory.

LaPrairie’s and Murphy’s work was supported by the National Institutes of Health, the Center for Behavioral neuroscience, a consortium of seven universities at Georgia State, and the Georgia State Brains and Behavior Program.

The article, titled “Neonatal injury alters adult pain sensitivity by increasing opioid tone in the periaqueductal gray,” appears in the September 2009 edition of journal Frontiers in Behavioral Neuroscience, Vol. 3, p. 1-11.

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Healing Pain Through the Art of Quilting

Patchwork of Hope Network (TM) Visits Atlanta to Raise Awareness of After-Shingles Pain

A local quilting group has joined a national initiative to help raise awareness of after-shingles pain, or postherpetic neuralgia (PHN), a particularly painful and debilitating disease. The group will be hosting an educational seminar in the area and invite members of the community to share their stories and reveal their quilting skills. Attendees will help by contributing to a patchwork quilt that is a handmade memorial and testimonial to those who suffer, and a reminder that they are a member of a community and do not have to face after-shingles pain alone.

Approximately 1 million Americans will suffer from shingles each year, and one in five of those people may develop PHN. PHN results from nerve damage caused by the shingles virus. For some PHN patients, a gentle breeze or a slight change in temperature can cause excruciating pain.

Together the National Council on Aging (NCOA) and the National Pain Foundation (NPF) are spreading the word about PHN through the Patchwork of Hope Network (P.H.N.) program. This often debilitating condition can affect not only those suffering, but their family and friends as well.

The campaign includes several live events throughout the year where attendees will hear presentations about PHN symptoms and potential treatment options, meet others affected by PHN and have an opportunity to create individual quilt squares to tell their story about how PHN has affected their lives.

Local physician Anthony Grasso, M.D., a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will discuss shingles and after-shingles pain and ways to cope. Additionally, a local PHN patient will share her personal experience with PHN and John Sebby, of the NPF, will discuss resources for dealing with PHN.

WHEN: Wednesday, August 19
10 a.m. to 12 noon

WHERE: Lou Walker Senior Center
2538 Panola Road
Lithonia, GA 30058
(770) 322-2900

About National Pain Foundation

The National Pain Foundation (NPF), a non-profit organization, is the premier provider of information, education and support to people with chronic pain. Materials are provided for both patients and medical professionals interested in the field of chronic pain. The NPF aims to empower people in pain by educating them about their condition, providing information about the options available for managing their pain, teaching them to take a more active role in their treatment plan and helping them to connect with others who also are on this journey. For more information, visit www.nationalpainfoundation.org.

About National Council on Aging

The National Council on Aging (NCOA) is a non-profit service and advocacy organization headquartered in Washington, DC. NCOA is a national voice for older Americans - especially those who are vulnerable and disadvantaged - and the community organizations that serve them. It brings together non-profit organizations, businesses and government to develop creative solutions that improve the lives of all older adults. NCOA works with thousands of organizations across the country to help seniors find jobs and benefits improve their health, live independently and remain active in their communities. For more information, visit www.ncoa.org.
REFERENCES

Harpaz R, Ortega-Sanchez IR and Seward JF. Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report. 2008; 57(05): 1-30. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm. Accessed February 20, 2009.

Shingles Vaccine: What You Need to Know. Department of Health and Human Services: Centers for Disease Control. Available at: http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-shingles.pdf. Accessed February 15, 2009.

Cure PHN: Your Questions Answered. VZV Research Foundation, Inc. 2004: 1-6. Available at: http://www.vzvfoundation.org/publicdownloads/PHN_Brochure_Feb2004.pdf. Accessed February 9, 2009.

Galer BS. Advances in the Treatment of Postherpetic Neuralgia: The Topical Lidocaine Patch. Today’s Therapeutic Trends. 2000; 1-20.
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Study Results Raise Questions About Vertebroplasty for Patients With Osteoporotic Spinal Compression Fractures

A new study led by Mayo Clinic researchers has found that relief of pain from vertebral compression fractures, as well as improvement in pain-related dysfunction, were similar in patients treated with vertebroplasty and those treated with simulated vertebroplasty without cement injections. The article, "A Randomized Controlled Trial of Vertebroplasty for Osteoporotic Spine Fractures," was released today in the New England Journal of Medicine.

Vertebroplasty is a widely applied procedure in which medical cement is injected into the spine to relieve pain and improve function in patients who have osteoporotic fractures. This study, funded by the National Institutes of Health, was the first of its kind, using a double-blinded research model to examine the impact of vertebroplasty.

"Though the medical community has been using vertebroplasty for many years, there were no research results to prove whether the efficacy of the treatment relates to the cement injections, patient expectations, or other factors," says the study's leader, David Kallmes, M.D., a Mayo Clinic physician who specializes in radiology and neurosurgery.

"The cement is a permanent medical implant, and there is some concern that it places patients at future risk for additional spinal fractures."

Researchers from eight medical centers in the United States, United Kingdom and Australia enrolled a total of 131 patients in the trial. The baseline characteristics of pain and function were similar in the vertebroplasty group containing 68 patients and the control group containing 63 patients. Within days of treatment, both groups showed similar improvements in function and pain. Researchers continue to follow study participants, and one year results will be released at a later date.

"We aren't saying the vertebroplasty doesn't work, because it somehow does," says Dr. Kallmes. "But both sets of patients experienced significant improvements in pain and function a month following the procedure, whether they received cement injections or not. Improvements may be the result of local anesthesia, sedation, patient expectations, or other factors."

"Patients should seek medical advice from their care provider before making a decision about treatment options," Dr. Kallmes advises.

Other centers involved in the research included the University of Washington, Seattle; Nuffield Orthopaedic Centre NHS Trust, Oxford, UK; St. George Hospital, University of New South Wales, Sydney, Australia; Gartnavel General Hospital, Glasgow, UK; Department of Social Medicine, Bristol, UK; Nottingham University Hospital NHS Trust, UK; and Western General Hospital, University of Edinburgh, UK. University of Washington researcher Jerry Jarvik, M.D., coordinated the data gathering and analysis for the project.

Dr. Kallmes says that several related research projects are in progress at Mayo Clinic, including a study of kyphoplasty, which uses a balloon to make space for cement injections, as well as an unblinded trial to measure the impact of local anesthesia on pain.
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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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Georgia State Study First to Confirm Long-Term Benefits of Morphine Treatment in Infants

A recent study conducted by researchers at Georgia State University is the first of its kind to demonstrate that administration of preemptive morphine prior to a painful procedure in infancy blocks the long-term negative consequences of pain in adult rodents. These studies have serious implications for the way anesthetics and analgesics are administered to neonates prior to surgery. Infant rodents that did not receive preemptive pain medication prior to surgery were less sensitive to the effects of morphine in adulthood. This means that infants undergoing invasive procedures at birth that do not receive any pain medicine will require more morphine in adulthood to modulate their pain.

This study -- conducted by Anne Z. Murphy, Ph.D., a Georgia State Professor of Neuroscience and member of the Center for Behavioral Neuroscience, and graduate student Jamie LaPrairie -- has serious clinical implications for the more than 400,000 human infants that are admitted to a newborn intensive care unit (NICU) in the United States each year.

Past studies have shown human infants born between 25-42 weeks gestation experience on average 14 painful procedures per day during the first two weeks of life with fewer than 35 percent receiving appropriate analgesic therapy.

“While such surgical procedures in preterm infants are clearly necessary, the resulting pain and inflammation has been shown to lead to negative behavioral consequences later in life,” Murphy said. “Our previous studies have shown that, just as in humans, neonatal inflammation in rodents (that did not receive preemptive pain medication) results in an increase in sensitivity to pain, stress, and decreased reaction to morphine as adults.

While evidence exists that morphine is efficacious in neonatal rodents, this is the first study to confirm the long-term behavioral benefits.

In this study, published online in Pediatric Research, a group of rat pups received an injection of morphine sulfate on the day of birth prior to inducing inflammation; another group received a saline injection instead. The groups were then raised identically and received identical procedures during a 60-day period. Rodents that received preemptive morphine behaved normally while those rats that received saline showed significant increases in pain sensitivity and were resistant to the pain relieving effects of morphine in adulthood.

“This tells us that morphine doesn’t work very well in human children and adults that were formally in the NICU and didn’t receive preemptive pain treatment, and since morphine is still the primary drug used to treat severe pain, this means that there is an entire subpopulation for which morphine doesn’t work efficiently,” Murphy said. “These results suggest that there are long-term benefits of providing all newborns with some sort of pain relieving medicine prior to the initiation of an invasive procedure.”

Murphy’s work was supported by the National Institutes of Health, the Center for Behavioral Neuroscience, and the Georgia State Brains and Behavior Program.

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Testing by Marine Biologists Concludes That Jellyfish Squish(TM) Completely Eliminates Pain From Jellyfish Stings

PRNewswire -- Peter Verity, Ph.D., is recognized throughout the world as a leading authority on jellyfish, but despite more than 20 years of research he had never identified a reliable treatment for jellyfish stings until he tested several home remedies against a new product called Jellyfish Squish(TM) last year.

Jellyfish Squish is a patent pending, trademarked topical anesthetic that has been endorsed by the American Lifeguard Association and has undergone extensive testing for the U.S. Food and Drug Administration. The solution immediately and completely eliminates the pain from a sting while also neutralizing any nematocysts left on the skin when a jellyfish tentacle comes into contact with flesh.

Dr. Verity is a faculty member at the Skidaway Institute of Oceanography (SKIO) near Savannah, Ga., and a decorated marine biologist who has published his findings throughout the world. Verity and fellow SKIO faculty member Richard Lee, Ph.D., performed extensive clinical tests on volunteer sting victims to compare the effectiveness of traditional homeopathic treatments for jellyfish stings such as vinegar, ammonia, baking soda, meat tenderizer and urea against the Jellyfish Squish formula.

"In our testing, we found that the formula which would later be named Jellyfish Squish was the only product that provided true relief from the pain and irritation caused by a jellyfish sting," said Dr. Verity, who is the chair of the Scientific Technical Advisory Committee for the State of Georgia Coastal Comprehensive Plan and has done extensive research on jellyfish and the recent jellyfish population boom. "Specifically, our clinical tests proved conclusively that home remedies like vinegar, ammonia and meat tenderizer are completely ineffective in providing relief to a sting victim and in fact can exacerbate the pain. We believe this is due to the presence of acidic pH, which triggers the release of additional toxins."

In addition to the clinical tests conducted by Dr. Verity and Dr. Lee, thousands of field tests performed on jellyfish sting victims on beaches in Georgia, Florida and South Carolina in 2007 supported the findings of the marine biologists.

Many lifeguard teams and emergency service providers have embraced Jellyfish Squish, and the medical division officer for the Okaloosa Island Fire Department on Florida's gulf coast recently decided to place a 4-ounce bottle of Jellyfish Squish in all of his team's medical gear bags and recommend that the product be used exclusively to treat sting victims.

"Immediately, you could tell there was total relief, and I only used a small amount of Jellyfish Squish because it was a kid," said Captain Kevin Carvalho, medical division officer for the Okaloosa Island Fire Department. "I have also used the product on adults who said it felt much better within moments and walked away from the truck to go back on the beach."

Growing coastal populations and heavier tourist traffic to the beaches means an increased frequency of jellyfish stings, and research released in 2007 documented hundreds of thousands of stings in Florida and Virginia's Chesapeake Bay area. Changing oceanic conditions are contributing to the proliferation of jellyfish worldwide, and record numbers of jellyfish have been reported in media stories throughout the Atlantic seaboard, the Pacific Coast, the Gulf Coast and Hawaii. In Europe, the jellyfish infestation has become so severe that Mediterranean beaches have periodically been forced to close.

"Several factors, particularly increased bacteria levels along with overfishing and higher water temperatures, have resulted in an increased number of jellyfish in the water and that will mean more people are going to suffer stings," Dr. Verity said.
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Knee Specialist Dr. Patrick Barry Performing New Non-Surgical Procedure That Eliminates Knee Pain, Helps Patients Avoid Knee-Replacement Surgery

BUSINESS WIRE--Patrick Barry, MD, an orthopedic surgeon and knee specialist, today (May 7, 2008) announced he has developed an effective alternative to surgery that helps eliminate knee pain and helps patients avoid knee-replacement surgery, which is the traditional treatment for chronic knee pain. The new procedure helps patients enjoy increased mobility and return to normal activities.

The “manipulation-mobilization” procedure, which Dr. Barry pioneered and perfected during the past three years on hundreds of cases in the US and abroad, takes a few minutes to perform in the office. It enables many patients, some of whom entered the doctor’s office by limping or using crutches or walkers, to immediately stand, walk freely without assistance and climb stairs without pain. Some of these patients already had surgery at other facilities but still suffered from knee pain.

“This new procedure is an effective alternative for those who have been told surgery is their only option to relieve knee pain, and it also has value for those who have not had surgery and would like to avoid it, as well as those who have been undiagnosed and told there is nothing wrong,” says Dr. Barry, who has performed more than 10,000 knee surgeries during his extensive medical career. “Many patients find their knee pain persists even after surgery and they spend years on pain medications and in physical therapy, only to later be told by their doctors that they need additional surgeries. Since I began offering this treatment, I am performing far fewer surgeries. Patient satisfaction has risen dramatically, as this treatment helps restore patients’ quality of life and dignity.”

Dr. Barry says the procedure is beneficial for patients of all ages and body weights. Almost all patients show significant improvements and pain reduction within seconds after undergoing the procedure.