On April 7, 2005, Pfizer voluntarily removed Bextra from the market due to the link of Bextra to an increase in heart attacks, strokes and Stevens Johnson Syndrome ("SJS"); and Toxic Epidermal Necrolysis ("TEN").
The Food and Drug Administration (FDA) approved Bextra on November 16, 2001 for joint pain of osteoarthritis and adult rheumatoid arthritis, and painful menstrual cramps. It was created by Pfizer, Inc. as a supposedly replacement for Pfizer's other pain relieving drug, Celebrex. The use of Bextra has grown, and culminated with Bextra becoming the number 51 ranked prescribed medication with sales of just over $900 million in 2003, and forecasted sales of $1.5 billion in 2005.
Bextra is a member of the cox-2 inhibitor family of non-steroidal anti-inflammatory drugs (NSAIDs) along with Vioxx and Celebrex. It is thought cox-2 inhibitors such as Bextra will help lower the risk of gastrointestinal ulcers and bleeding than other traditional NSAIDs such as aspirin or ibuprofen. Recently, the cox-2 inhibitor family has come under attack with finding that they increase the risk of heart attacks and strokes. On November 10, 2004, only three years after the FDA first approved it, Bextra was found to increase the risk for heart attacks and stroke, and it was found linked to potentially fatal skin disease. On January 13, 2005, the FDA called for the immediate halt to all Bextra advertisements. The FDA stated that advertisements for the drug were "misleading and unsubstantiated, overstating the benefits and understating the risks." Then, on April 7, 2005, Pfizer voluntarily removed Bextra from the market after encouragement by the FDA to do so.
The removal of Bextra from the market comes after two other COX-2 inhibitor drugs have been found to also increase the risk of heart attack and strokes in users. Merck's pain relieving drug, Vioxx, was also withdrawn from the market in September 2004, and Pfizer's other COX-2 inhibitor drug, Celebrex, was found linked to an increase in heart attacks and strokes in December 2004.
Bextra users are strongly urged to speak with their doctors about their Bextra use. The FDA and Pfizer have both made commitments to further study the harmful side effects of Bextra and other COX-2 inhibitor drugs.
Only a few studies have looked directly at Bextra's heart safety. One trial released in December suggested that the drug raised the risk of heart attacks in patients undergoing heart bypass surgery.
Meanwhile, the FDA said it had received an abnormally high number of reports implicating Bextra in dangerous skin reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome. Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are two forms of a life-threatening skin disease that cause rashes, skin peeling, and sores on the mucous membranes. In SJS, a person has blistering of mucous membranes, typically in the mouth, eyes, and genitals, and patchy areas of rash. In TEN, there is a similar blistering of mucous membranes, but the entire top layer of the skin peels off in sheets from large areas of the body as well. Both SJS and TEN cause sever organ damage, permanent disfigurement and death.
"It has the same cardiovascular problem, no specific benefit, and this added worse skin risk," says Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research. "Bextra has a special risk in addition to the class risk."