Celebrex, a pain relief drug from Pfizer Inc., will include a boxed warning, highlighting the potential for increased risk of heart problems and the serious, potential life-threatening gastrointestinal (GI) bleeding associated with its use, the Food and Drug Administration said Thursday in a statement.

The agency is asking manufacturers of all prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Cox-2 selective drugs, to revise the labeling for their products to included this boxed warning.

Concerns about the safety of COX-2 inhibitors, like Celebrex and Bextra, another drug made by Pfizer Inc., increased when Vioxx was pulled from the market by Merck & Company in September 2004, after a study found that it increases a patients’ risk of heart attack and stroke.

Manufactures of non-prescription (over-the-counter) NSAIDS, including Motrin and Advil (ibuprofen) and Aleve (naproxen), are also being asked to revise their labeling to provide more specific information about the potential CV and GI risks of their individual products. In addition, the FDA is asking that the labels for Motrin, Advil and Eleve to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

FDA asked Pfizer to remove Bextra (valdecoxib) from the market on Thursday because the overall risk versus benefit profile for the drug is unfavorable.

(via U.S. Food and Drug Administration)