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Bextra pulled, other painkillers to carry stronger warnings

Physician Practice Advisor, April 13, 2005

Another high-profile pain reliever, Bextra, was removed from shelves last
Thursday, following in the footsteps of September's recall of Vioxx. Like Vioxx, Bextra was taken off shelves because of studies that linked the drug to an increase in the risk of heart attack and stroke.

According to the Associated Press, the Food and Drug Administration
(FDA) will also now require 19 other prescription competitors, including
Celebrex and Mobic, to bear large black-box warnings that tell consumers they also carry similar risks, as well as indications that long-term use may cause serious cardiovascular side effects or gastrointestinal bleeding.

Additionally, the FDA will make over-the-counter non-steroidal
anti-inflammatory drugs (NSAIDs) bear stronger reminders that they should be taken only in low doses for short periods of time. The FDA advises patients who currently take any of these medications to call their physicians, find out which drug is best suited for their particular situation, and take the lowest doses possible.

Bextra, which is manufactured by Pfizer, was taken off the market last week at the request of the FDA and European drug regulators. Those bodies cited the increased risk of cardiac concerns, as well as the appearance that Bextra has been known to cause rare but serious skin conditions in patients more often than other NSAIDs.

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