FDA Orders Pfizer to Withdraw Bextra From US Market

Bextra Withdrawn Due to Increased Risks of Cardiovascular Problems and Serious Skin Reactions

In April 2005, the FDA asked Pfizer to withdraw the COX-2 inhibitor Bextra from the market because it significantly increases the risk of heart attack and stroke. Other drugs in the COX-2 class, such as Celebrex, will be required to add a black box warning, the strongest safety warning possible. The Food and Drug Administration has been studying the safety of COX-2 inhibitors since Merck voluntarily pulled Vioxx from the market in September 2004 after heart problems were reported in some Vioxx users.

In addition to carrying an increased risk for heart attacks and strokes, Bextra is associated with a serious skin reaction called Stevens-Johnson Syndrome, which can cause life-threatening blisters on the skin, mouth, and eyes.

The Bextra withdrawal by Pfizer includes a suspension of Bextra sales in Europe, as well as the United States.

Read more on our Bextra Information Page >>