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Pain Reliever Recalled After 4 Die

June 22, 1998

NEW YORK (AP) _ The maker of Duract recalled the potent painkiller Monday after four patients died and eight others required liver transplants.

American Home Products’ Wyeth-Ayerst division pulled the drug from the market less than six months after the Food and Drug Administration warned that the prescription pain reliever can lead to potentially fatal liver damage in patients who use it longer than 10 days.

Since Duract hit the market in July 1997, doctors have made it a popular alternative to narcotic drugs for the short-term pain relief needed after surgery and for other acute pain. Physicians have written 2.5 million prescriptions for the drug.

The recall ends a controversy in the medical community that has surrounded the pain reliever. 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.

Wyeth-Ayerst and FDA 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.

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.

The recall points out the liver problems of NSAID drugs in general, said Dr. Gerard Varlotta, a sports medicine specialist at the New York School of Medicine’s Rusk Institute.

``We’re concerned about long-term use of any non-steroidal anti-inflammatory,″ said Varlotta, although few patients experience such severe problems. ``If you ask people how many pills they’re taking they’re taking prescription dosages of Motrin.″

Yet living without such drugs is inconceivable for patients like Denise Huntington, who has suffered from chronic pain since she was 17. She’s taken many similar painkillers, but not Duract.

``They’re all the difference between life and death,″ said Ms. Huntington, 43, of Steuben, Maine. ``It means all the difference between you being disabled or a productive citizen. It means you can get up in the morning.″

Although Duract is not intended for arthritis or other chronic pain that requires long-term medication, some doctors are believed to have prescribed it for those conditions. The FDA warned doctors previously that anyone prescribing Duract for longer than the FDA-approved time must watch for signs of liver toxicity.

The recall is only the latest blow for American Home, which is coping with lawsuits from thousands of dieters who claim they were harmed by two widely used diet pills _ Redux and fenfluramine _ the company pulled from the market in August.

American Home shares fell 2 percent, dipping $1.06 to $51.06 on the New York Stock Exchange.

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