FDA Warns Against New Painkiller

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:    Frankp@chiro.org

February 11, 1998
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WASHINGTON – The Associated Press

Patients who take a potent new painkiller for longer than 10 days can suffer potentially fatal liver damage, the Food and Drug Administration said in a stern warning Tuesday to doctors who prescribe the drug Duract.

– Duract began selling in August, as a nonnarcotic alternative for the short–term pain relief needed after surgery and for other acute pain.

– But the FDA said at least seven patients since then have suffered jaundice, severe hepatitis or even liver failure that required transplants.

– The FDA had approved the potent analgesic to be used for just 10 days, but each injured patient had taken Duract for more than a month, manufacturer Wyeth–Ayerst Laboratories said in letters to 200,000 doctors Tuesday.

– Duract is not intended for arthritis or other chronic pain that requires long–term medication. The agency warned doctors last summer that anyone prescribing Duract for longer than the FDA–approved time must watch for signs of liver toxicity.

– Wyeth–Ayerst said the injured patients had not been properly monitored.

– The FDA acknowledged the number of injuries reported is very small, but said it had no way to tell exactly how many Duract patients may have suffered liver damage. The agency urged doctors to report side effects from Duract.

– And the FDA told Wyeth–Ayerst to add to Duract's label the agency's strongest safety warning, a black box that explains the potentially fatal reactions and stresses the 10–day prescription limit.

– "While not recommended, if a physician determines that the risk of longer use is justified by the potential benefit," the patient must undergo liver toxicity testing, the warning adds.

– Duract, known chemically as bromfenac, was welcomed last summer as an alternative to the narcotic pain relievers that many doctors are reluctant to prescribe. Studies showed Duract was as effective as the top narcotics, but did not cause opiate side effects or addiction.

– The health–care information company IMS America counts 1.3 million Duract prescriptions written since August. Wyeth–Ayerst contends the vast majority are for appropriate, short–term use.

– "When used as directed, Duract remains highly effective," said spokesman Doug Petkus.

Copyright 1998, Associated Press

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