[AHP] Painkiller Recalled After Four Die
Tuesday June 23, 12:20 am Eastern Time
By JOHN HENDREN
AP Business Writer
NEW YORK (AP) -- American Home Products (NYSE:AHP - news) is recalling its powerful painkiller Duract after four patients died and eight others needed to have liver transplants.
The recall comes less than six months after federal regulators warned that Duract could lead to fatal liver damage if used for more than 10 days. The prescription-only drug, which went on sale in July 1997, had become a popular alternative to narcotic drugs for short-term relief of acute pain.
The drug had been controversial in the medical community. Five months after Duract came out, the consumer group Public Citizen warned patients against using the drug, saying doctors could easily prescribe one of at least 18 similar treatments.
AHP's Wyeth-Ayerst division and Food and Drug Administration officials maintain Duract is safe if used for less than 10 days, the period for which the drug was approved. But doctors are free to prescribe it for longer periods and have done so for about 15 percent of the patients who take it, according to FDA figures. Doctors have prescribed the drug 2.5 million times.
There was no way to make the warning any clearer to doctors who continued to prescribe the drug for longer use, said Dr. Murray Lumpkin, deputy director for the FDA's Center for Drug Evaluation
and Research.
''Given the alternatives ... it made no sense to accept death and liver transplants when there are alternatives available,'' he said.
Duract is one of the most powerful of a class of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs, that include aspirin and ibuprofen.
The clinical tests the FDA viewed to evaluate the drug could not have detected the problems because they are so rare -- about 1 in 50,000 to 100,000 cases -- Lumpkin said. All of the deaths have been reported since the drug's warning label was changed in February.
''In clinical trials we cannot pick up those kinds of rare numbers,'' Lumpkin said. ''It would take decades to do clinical trials.''
Critics say the drug should never have been approved because even the clinical tests showed evidence of elevated liver enzymes that suggested liver problems were possible.
''You have 19 or 20 other drugs in the same class, and one comes along with a unique ability to cause liver damage,'' said Public Citizen spokesman Larry Sasich, a pharmacist. ''Why should a drug like that be approved?''
All but one of the twelve patients who died or had transplants had taken the drug for more than 10 days. The exception was a patient who had a previous history of alcoholism and liver failure who had visited a hospital emergency room twice in the week before his death, according to FDA and Wyeth-Ayerst officials.
He died of a blow to the head in a bar fight, but had elevated liver enzymes at the time. It wasn't clear if Duract contributed to his death, Lumpkin said.
Wyeth-Ayerst has sent letters to more than 600,000 doctors in the United States, urging them to stop prescribing the drug immediately. The letter also asks doctors to consider contacting patients who may be using the product longer than 10 days or who have a history of liver disease.
''The majority of patients were not at risk, but the possibility of other patients receiving the drug for longer (than 10 days) ... led us to stop marketing the drug,'' Dr. Philip de Vane, head of clinical
affairs for Wyeth-Ayerst, said.
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