Both the US Food and Drug Administration (FDA) and the European Union's regulators have asked that Pfizer pull Bextra from the market. Pfizer has agreed to do so.

A press release from the FDA stated, "overall risk versus benefit profile for the drug is unfavorable."

This comes after the FDA had already placed a black box label - the most serious warning label a medication can receive - on Bextra in December of 2004 because of the possibility of serious cardiovascular side effects, as well as possible serious skin reactions.

Kaiser Permanente, the nation's largest not-for-profit managed-care provider, stopped prescribing Bextra in February, 2005.

The FDA has also asked Pfizer to add a black box label on Celebrex, another medication in the same class as Bextra: The COX-2 inhibitors (also known as coxibs). Pfizer has agreed to work with the FDA on the label, and it appears from the FDA's press release that the label will deal with increased risk of cardiovascular risk when taking the drug.

These are just two of many changes the FDA is making in order to highlight the safety issues of the COX-2 inhibitors, as well as the safety of all non-steroidal anti-inflammatory drugs (NSAIDs). According to the FDA's press releasse, "These actions are based on the available scientific data," and, "recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005."