Pfizer updates warning about Bextra and Stevens-Johnson Syndrome

Pfizer updates warning about Bextra and Stevens-Johnson Syndrome

01/05/07

Pfizer, the pharmaceutical manufacturer of the COX-2 inhibitor Bextra, updated its warning about its drug’s link to a rare but fatal skin disorder known as Stevens-Johnson syndrome. Pfizer stated that cases of the condition are seen more often with Bextra than other drugs in the same class. An experimental intravenous version of the drug Pfizer is currently working on may never reach the U.S. market in the wake of this news.

Stevens-Johnson syndrome is a form of allergic reaction usually caused by certain types of drugs. Symptoms usually begin as a blistering of the lips and mouth that spreads to the throat, tongue, and other parts of the body. The blisters sometimes become so extensive that they are fatal. Jean Farrell, founder of the non-profit Stevens-Johnson Foundation, said that within weeks of Bextra hitting the market she had an increase in calls about the disease, claiming to have had “six cases of SJS reported to us” within three weeks of the availability of Bextra.

Following the withdrawal of Vioxx, Merck and Co.’s similar anti-inflammatory medication, Pfizer announced the findings of two small clinical trials that showed heart bypass surgery patients taking Bextra also had an increased risk of heart attack and stroke.

Source: Reuters Health , “Another Arthritis Drug Shows Risks,” 11/01/04.

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