Bextra – Product Recall

On Apr-07-05 the FDA asked the maker of Bextra, Pfizer, to remove the pain medication from shelves across the United States. Canada Health quickly followed suit and asked Pfizer to also remove Bextra from Canadian shelves. Pfizer has also suspended sales of Bextra in the European Union.

Bextra has been prescribed to arthritis sufferers to relieve symptoms of osteoarthritis and rheumatoid arthritis. Bextra is classified as a Cox-2 inhibitor, a newly developed drug in the Non-Steroidal Anti-Inflammatory (NSAID) family. To date, several Cox-2 inhibitors have been banned due to the increased risk of stroke, heart attack, stomach ulcers, liver damage, and severe skin reactions among patients.

On Jan-29-05, health care giant Kaiser Permanente, an HMO serving 2.6 million Californians, stopped prescribing Bextra to its patients.

"This is not a drug that saves lives,'' said Dr. Sharon Levine, a pediatrician who oversees medication usage for Kaiser Permanente's Northern California division. "it's a drug that provides a modest degree of pain relief -- no better than Motrin -- and the size of the risk, given the benefit provided, did not seem warranted.''

On Dec-10-04 the FDA increased the warning on Bextra labels to include a "black box" warning against using the medication for patients with cardiac problems.

On Nov-11-04, University of Pennsylvania researchers told the American Heart Association that a recent clinical trial revealed that patients taking Bextra had more than twice the incidence of heart attack and stroke than nonusers.

On Oct-18-04, Pfizer admitted that two small clinical trials showed heart bypass surgery patients taking Bextra had a higher risk of stroke and heart attack.

University of Pennsylvania pharmacologist Dr. Garret FitzGerald claims "The magnitude of [cardiac problems] with Bextra is even higher than what we saw in Vioxx." Bextra's risk appeared to pose a slightly higher risk than Vioxx for heart attack and stroke. FitzGerald believes that the same mechanism that makes the Cox-2 inhibitor drugs easier on the stomach also blocks a substance that prevents heart problems.

Bextra in the News

Bextra lawsuit filed in U.S. District court - East St. Louis on behalf of seven plaintiffs; five plaintiffs allegedly suffered strokes and heart attacks after taking the prescription pain reliever and two plaintiffs are filing complaints after their family member died due to cardiovascular problems allegedly associated with Bextra. The lawsuit seeks damages against Pfizer, Pharmacia, Monsanto and Searle with claims that the companies did not disclose proper warnings regarding Bextra's side effects and failed to adequately test Bextra prior to distribution. Monsanto and Searle merged with Pharmacia in 2000 and Pfizer and Pharmacia merged in 2003. (Oct-05-05) [THE RECORD]

Pfizer tried to pass an injectable pain medication similar to Bextra but the FDA disapproved the drug. Bextra was removed from the market last year after it was linked to the deadly skin disease Stevens-Johnson Syndrome. (Sep-20-05) [CNN]

The FDA issues a Public Health Advisory to patients using Cox-2 inhibitors and pulls Bextra off the market. (Apr-07-05) [FDA]

Bextra’s new black box warning label is. (Nov-22-02) [FDA]

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