Drug & Device News

Doctors used to be able to prescribe several ostensibly safe and reliable pain medications to their patients without giving much thought to dangerous side effects. That situation recently changed when the FDA announced that it would require manufacturers of several anti-inflammatory drugs — including COX-2 selective and prescription and over-the-counter non-selective NSAID medications — to change the warning information on their labels and inserts. In conjunction with these changes, the FDA asked Pfizer Inc. to withdraw Bextra' (valdecoxib) from the market and asked the company to include a boxed warning in the label for Celebrex' (celecoxib), another of its products. Other manufacturers of prescription and non-prescription NSAIDS were not spared; they, too, were asked to revise their drugs' labels to highlight the potential for increased risk of cardiovascular and gastrointestinal problems associated with use of such products. In addition, the FDA asked the manufacturers of all over-the-counter NSAIDs to revise their labels to include a warning about potential skin reactions. Prescription NSAIDs already carry such warnings.

Eli Lilly Suspends Testing

Studies on children of Xigris', a sepsis drug, were halted by the drug's manufacturer, Eli Lilly & Co., late in April because its use was found to be associated with an increased risk for bleeding and the drug did not perform better than placebo. Of the 399 children taking part in the testing, 201 were given Xigris and 198 received placebos. One of the children on placebo experienced bleeding in the brain, while four of the children taking Xigris had this problem.

Merck Researchers May Have Hidden Bad Results

The New York Times reported on April 28 that in 2000, a senior Merck scientist pressed a researcher whose patient had died while taking the drug Vioxx' not to report that she had died of a heart attack, as suspected. (Berenson, New York Times, 4/28/04.) The cause of that patient's death listed in a report to the FDA was “unknown,” according to the Times article. Vioxx was withdrawn from the market last year in response to evidence that the drug caused heart problems.

Merck Claims Plaintiff Lied

Merck's attorneys asked an Alabama judge to dismiss a case against the drug manufacturer for a death allegedly caused by use of Vioxx. The drug was taken off the market last fall because it has been shown to increase the risk of heart attack and strokes. Plaintiff Cheryl Rogers claims that her 42-year-old husband received samples of Vioxx from his physician and died of a heart attack after taking the drug for shoulder pain. Merck moved to dismiss with prejudice, asserting the drug samples the plaintiff produced and claimed the deceased took were in fact not shipped from the manufacturer until after Rogers died. The suit is one of the first of many personal injury claims being brought across the nation in fact seeking damages for injuries caused by their use of Vioxx.

Sleeping Aids May Actually Prevent Geriatric Patient Injury

While health care providers often shy away from prescribing sleep aids to the elderly for fear they will become more susceptible to falling while under their influence, a new study published in the Journal of the American Geriatrics Society suggests a related culprit may be causing more falls than drugs: insomnia itself. The study looked at approximately 34,000 nursing home residents over age 65. Those who began the study with untreated insomnia were 90% more likely to fall than those who did not suffer from insomnia. Elderly patients with insomnia who were prescribed hypnotic sleep aids were only 29% more likely to fall than those without sleep problems. The bottom line, according to the study's authors, is that sleeplessness causes mental and motor impairment that may lead to more falls than the effects of carefully prescribed sleep medication.

Public Citizen Petitions FDA to Take ADHD Drug Off the Market

Consumer group Public Citizen has petitioned the FDA to take the drug pemoline (Cylert'), a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD), off the market, charging that its known risks to liver function should preclude the drug's use. Pemoline was prescribed to approximately 117,000 U.S. patients in 2004 despite the fact that 21 cases of liver failure have been caused by its use, according to the group. The drug is no longer available in Canada and the United Kingdom because of an unfavorable risk-to-benefit ratio, but the FDA has stopped short of a ban, requiring instead only black box warning labels.

Seizure Drug Labels Warn of New Dangers

In a letter sent April 18, Novartis Pharmaceuticals and the Food and Drug Administration (FDA) notified health care professionals about revisions to the “Warnings” and “Precautions” sections of the prescribing information for Trileptal'(oxcarbazepine) tablets and oral suspension. Trileptal is used for treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated “Warnings” section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that have been reported in both children and adults in association with Trileptal use. The “Precautions” section was updated to warn of multi-organ hypersensitivity reactions that some users of Trileptal have reported experiencing.

FDA Clamps Down On Marketing of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Doctors used to be able to prescribe several ostensibly safe and reliable pain medications to their patients without giving much thought to dangerous side effects. That situation recently changed when the FDA announced that it would require manufacturers of several anti-inflammatory drugs — including COX-2 selective and prescription and over-the-counter non-selective NSAID medications — to change the warning information on their labels and inserts. In conjunction with these changes, the FDA asked Pfizer Inc. to withdraw Bextra' (valdecoxib) from the market and asked the company to include a boxed warning in the label for Celebrex' (celecoxib), another of its products. Other manufacturers of prescription and non-prescription NSAIDS were not spared; they, too, were asked to revise their drugs' labels to highlight the potential for increased risk of cardiovascular and gastrointestinal problems associated with use of such products. In addition, the FDA asked the manufacturers of all over-the-counter NSAIDs to revise their labels to include a warning about potential skin reactions. Prescription NSAIDs already carry such warnings.

Eli Lilly Suspends Testing

Studies on children of Xigris', a sepsis drug, were halted by the drug's manufacturer, Eli Lilly & Co., late in April because its use was found to be associated with an increased risk for bleeding and the drug did not perform better than placebo. Of the 399 children taking part in the testing, 201 were given Xigris and 198 received placebos. One of the children on placebo experienced bleeding in the brain, while four of the children taking Xigris had this problem.

Merck Researchers May Have Hidden Bad Results

The New York Times reported on April 28 that in 2000, a senior Merck scientist pressed a researcher whose patient had died while taking the drug Vioxx' not to report that she had died of a heart attack, as suspected. (Berenson, New York Times, 4/28/04.) The cause of that patient's death listed in a report to the FDA was “unknown,” according to the Times article. Vioxx was withdrawn from the market last year in response to evidence that the drug caused heart problems.

Merck Claims Plaintiff Lied

Merck's attorneys asked an Alabama judge to dismiss a case against the drug manufacturer for a death allegedly caused by use of Vioxx. The drug was taken off the market last fall because it has been shown to increase the risk of heart attack and strokes. Plaintiff Cheryl Rogers claims that her 42-year-old husband received samples of Vioxx from his physician and died of a heart attack after taking the drug for shoulder pain. Merck moved to dismiss with prejudice, asserting the drug samples the plaintiff produced and claimed the deceased took were in fact not shipped from the manufacturer until after Rogers died. The suit is one of the first of many personal injury claims being brought across the nation in fact seeking damages for injuries caused by their use of Vioxx.

Sleeping Aids May Actually Prevent Geriatric Patient Injury

While health care providers often shy away from prescribing sleep aids to the elderly for fear they will become more susceptible to falling while under their influence, a new study published in the Journal of the American Geriatrics Society suggests a related culprit may be causing more falls than drugs: insomnia itself. The study looked at approximately 34,000 nursing home residents over age 65. Those who began the study with untreated insomnia were 90% more likely to fall than those who did not suffer from insomnia. Elderly patients with insomnia who were prescribed hypnotic sleep aids were only 29% more likely to fall than those without sleep problems. The bottom line, according to the study's authors, is that sleeplessness causes mental and motor impairment that may lead to more falls than the effects of carefully prescribed sleep medication.

Public Citizen Petitions FDA to Take ADHD Drug Off the Market

Consumer group Public Citizen has petitioned the FDA to take the drug pemoline (Cylert'), a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD), off the market, charging that its known risks to liver function should preclude the drug's use. Pemoline was prescribed to approximately 117,000 U.S. patients in 2004 despite the fact that 21 cases of liver failure have been caused by its use, according to the group. The drug is no longer available in Canada and the United Kingdom because of an unfavorable risk-to-benefit ratio, but the FDA has stopped short of a ban, requiring instead only black box warning labels.