Prescription pain-reliever recalled following four deathsJun 22, 1998 | AP The potent painkiller Duract was recalled by its manufacturer today after four people who took it died and eight others required liver transplants.
The recall by American Home Products' Wyeth-Ayerst division comes less than six months after the Food and Drug Administration warned that the potent prescription painkiller can lead to potentially fatal liver damage in patients who use the drug 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 FDA approved the drug for use up to 10 days, but doctors are free to prescribe it for longer periods.
''We believe this voluntary action is in the best interest of patients,'' Dr. Philip de Vane, head of clinical affairs for the company, said in a statement. ''While we continue to believe that Duract is safe and effective when used for 10 days or less, rare but serious adverse events have been associated with Duract when used for longer periods.''
The company concluded that keeping the product on the market -- with a stronger warning against using it for more than 10 days -- ''would not be feasible or effective,'' de Vane said.
All but one of the 12 cases resulting in death or a liver transplant involved patients who used the drug for longer than 10 days, the company said. The one who used it for a shorter time but had ''significant'' pre-existing liver disease.
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 FDA said in February that at least seven patients had suffered jaundice, severe hepatitis or even liver failure that required transplants.
Duract is not intended for arthritis or other chronic pain that requires long-term medication. The agency warned doctors in the summer of 1997 that anyone prescribing Duract for longer than the FDA-approved time must watch for signs of liver toxicity.
The recall is 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 the company pulled from the market in August.