Duract
Bromfenac Sodium
History
and Background
Wyeth-Ayerst Laboratories, a division of American Home
Products Corporation (NYSE:AHP) developed Duract as a non-steroidal
anti-inflammatory or NSAID pain reliever.
Duract was released it on the market on July 15,
1997, but kept on the market for only eight months.
Early studies of the drug found that it caused severe liver
damage if taken for more than (10) ten days.
The FDA had initially instructed AHP to include a
Black Box warning, but AHP strenuously resisted, including
the warning in the fine print of the package insert instead.
AHP finally changed the label in February of 1998,
but four deaths had already occurred.
How many prescriptions of Duract were written?
During the eight month period that Duract was on the market,
2.5 million prescriptions were written and as many as 400,000
people may have taken the medication.
So far 68 deaths have been reported.
Why was Duract so popular?
Duract provided an alternative to narcotic drugs for short-term
relief of pain. It
was also one of the strongest and most effective NSAID’S.
Special Considerations:
·
Liver Damage must have occurred while taking Duract. This can occur
in as few as four days
·
Individuals that took Duract as a long-term treatment (more than 10
days) or had pre-existing liver problems are most at risk
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