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celebrex safety label

FDA Advisory Panel Recommends Softening “Celebrex” Safety Labeling

A U.S. Food and Drug Administration (FDA) advisory panel concluded that prescription pain medication celecoxib (Celebrex), marketed by Pfizer, is as safe as other common nonsteroidal anti-inflammatory drugs (NSAIDs) when it comes to cardiovascular (CV) risks. The panel recommended updating the medicine’s safety labeling to reflect that.

Celecoxib is a selective COX-2 inhibitor, which means it blocks production of an enzyme associated with inflammation. “Nonselective” NSAIDs, such as naproxen and ibuprofen, block both COX-1 and COX-2; by blocking COX-1, they give rise to gastrointestinal (GI) side effects. Celecoxib is often prescribed to patients with osteoarthritis (OA) or an inflammatory type of arthritis, such as rheumatoid arthritis (RA), especially those who are at higher risk of GI side effects.

But its cardiovascular safety profile has been under a cloud of suspicion for more than a decade, after two other COX-2 inhibitors were pulled from the U.S. market. Rofecoxib (Vioxx) was removed in 2004 and valdecoxib (Bextra) in 2005 over concerns they raised the risk of cardiovascular events, such as heart attack and stroke, to unacceptable levels. (All NSAIDs increase the risk of cardiovascular side effects; risks rise with the dose and length of time used.)

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