February 11, 1998
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
– Wyeth–Ayerst said the injured patients had not been
– 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
– "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
– 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,
– "When used as directed, Duract remains highly
effective," said spokesman Doug Petkus.
Copyright 1998, Associated Press