[U.S. Food and
Drug  Administration]

This is the retyped text of a Press Release from Wyeth-Ayerst Laboratories.


FOR IMMEDIATE RELEASE

Contacts:
Douglas Petkus (610) 971-4980
or
Audrey Ashby (610) 971-5823

DURACT VOLUNTARILY WITHDRAWN

Postmarketing reports of rare, but serious liver events associated with long-term use

ST. DAVIDS, PA -- JUNE 22, 1998 -- Wyeth-Ayerst Laboratories, a division of American Home Products Corporation (NYSE:AHP), today announced the voluntary market withdrawal of DURACT (bromfenac sodium capsules), a nonsteroidal anti-inflammatory analgesic indicated for the short-term (10 days or less) management of acute pain.

The company is taking this action based on postmarketing reports of severe hepatic failure resulting in four deaths and eight liver transplants. All but one of those 12 cases involved patients using DURACT for longer than 10 days -- the maxium recommended duration of treatment. The exception involved a patient with pre-existing significant liver disease.

"We believe this voluntary action is in the best interest of patients," says Dr. Philip de Vane, Vice President, Clinical Affairs and North American Medical Director, Wyeth-Ayerst Laboratories. "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."

DURACT was introduced in July 1997, and approximately 2.5 million prescriptions have been dispensed -- the great majority of these for 10 days or less. In February 1998, the company and the Food and Drug Administration agreed on labeling changes to further emphasize that DURACT should be used for 10 days or less. These changes were initiated in response to earlier reports of serious events associated with longer-term use.

"Although the revised labeling reduced the number of prescriptions of longer duration and the reports of severe liver events, it did not eliminate them," says Dr. de Vane. "The company has now concluded that further steps to limit use of a potent NSAID pain reliever such as DURACT to just 10 days would not be feasible or effective. In light of these circumstances, as well as the availability of other therapies, Wyeth-Ayerst has decided to withdraw the product."

Wyeth-Ayerst has sent letters of notification to more than 600,000 health care professionals in the United States. They are being advised to stop prescribing and dispensing DURACT immediately. In addition, they have been asked to consider contacting patients who may be using the product longer than 10 days or who have a history of liver disease, and advise these patients to discontinue treatment. Patients are advised to discuss concerns related to DURACT with their physician.

A special information line, 1-800-281-9260, is available to provide answers to questions about DURACT.

Wyeth-Ayers Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company.

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