In September 2004 Merck announced the withdrawal of the popular
anti-inflammatory drug Vioxx from the market due to a study that
showed patients taking the drug faced twice the risk of heart attack
and stroke. Since then, the safety of non-steroidal anti-inflammatory
drugs (NSAIDs) has been reevaluated and Pfizer's Bextra, an
NSAID known as a COX-2 inhibitor, has suffered the consequences.
The Food and Drug Administration (FDA) announced that Pfizer has
agreed to stop selling Bextra due to the risk of rare but life-threatening
skin reactions. Of all the anti-inflammatory pain relievers, Bextra
was most frequently sourced in reports of skin reactions.
New "Black-Box" Warning for
Anti-Inflammatory Pain Relievers
The FDA will require a "black-box" warning--the strongest
warning possible--to be placed on the labels of Pfizer's blockbuster
arthritis drug Celebrex, and other, older prescription anti-inflammatory
pain relievers such as ibuprofen and naproxen. The warning will
specifically caution against possible cardiovascular and gastrointestinal
risks including:
- Strokes
- Heart attacks
- Bleeding of the digestive tract
Pain relievers that can be purchased over the counter will also
include similar information on their labels, as well as a warning
regarding potentially fatal skin reactions. (The wording of the
warnings will differ depending on whether the drug is sold by prescription
or over the counter.)
Pfizer advises patients, for the time being, to resist using Bextra
and to contact their doctors about appropriate treatment options.
USA
Today April 7, 2005
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