PRESCRIPTION PAIN-RELIEVER RECALLED FOLLOWING FOUR DEATHS

NEW YORK (AP) -- The potent painkiller Duract was recalled by its
manufacturer Monday 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.

"...in the best interest of patients..."

"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.

Checked-by: Melodi Cornett