FDA recommends restrictions on use of Celebrex, Bextra
Last Updated: Thursday, December 23, 2004 | 7:18 PM ET
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The U.S. Food and Drug Administration said it was "recommending limited use of COX-2 inhibitors," a class of drugs that were hailed for treating arthritis and inflammation.
- INDEPTH: Arthritis drug concerns
COX-2 inhibitors still on the market include Pfizer's Celebrex and Bextra. Merck and Co. recalled another COX-2 inhibitor, Vioxx, in September after it was associated with an increased risk of heart attacks.
All three drugs "may be associated with an increased risk of serious cardiovascular events [heart attack and stroke] especially when they are used for long periods of time or in very high risk settings [immediately after heart surgery]," the FDA said in a public health advisory.
"Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients."
The regulator said it may be appropriate to use COX-2 inhibitors for patients who:
- Have a high risk of gastrointestinal bleeding.
- Have a history of intolerance to non-selective NSAIDS.
- Are not doing well on non-selective NSAIDs.
- FROM DEC. 21, 2004: Heart risks prompt U.S. to halt naproxen trial
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