FDA recommends restrictions on use of Celebrex, Bextra

Last Updated: Thursday, December 23, 2004 | 7:18 PM ET

CBC News

Doctors are advised to limit their use of anti-inflammatory drugs linked to a higher risk of heart attack and stroke, U.S. regulators said Thursday.

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 were originally promoted as being easier on the stomach than older drugs called standard nonsteroidal anti-inflammatory drugs or NSAIDs, such as ASA and ibuprofen.

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.

The FDA also said it was considering ordering a re-evaluation of trials designed to test the potential of COX-2 inhibitors to prevent cancer.

• FROM DEC. 21, 2004: Heart risks prompt U.S. to halt naproxen trial

Such cancer research revealed the heart problems associated with high doses of Vioxx and the non-selective drug Naproxen.