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Following FDA urgings, Pfizer removed Bextra from the market on April 7, 2005. The FDA made their request based on high incidences of heart attacks, strokes and the potentially fatal skin condition known as Stevens-Johnson Syndrome amount patients using Bextra.
Released in 2001 by Pfizer, Bextra was approved for use in the treatment of pain associated with osteoarthritis, rheumatoid arthritis and dysmenorrhea. Bextra packaging originally included a warning about side effects such as stomach pain, diarrhea, heartburn, back pain, headache, nausea, and upper respiratory infection. The FDA did not feel that was sufficient and ordered Pfizer to strengthen the Contraindications, Warnings, and Adverse Reactions sections of Bextraís prescribing information in November 2002.
Bextra is a member of the COX-2 family of drugs that also includes Vioxx and Celebrex. When they were first released in the late 1990s, the COX-2 painkillers were marketed as miracle drugs for arthritis sufferers. More recently, however, the COX-2 drugs have been associated with heart attacks and strokes. Bextra has also been associated with severe skin reactions, Stevens Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme.
In November 2004, a study presented to the American Heart Association indicated that Bextra users were at double the risk of fatal heart attacks, as compared with Vioxx (which was removed from the market in October 2004) and Celebrex. Bextra also appears to increase a patientís risk of stroke.
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