Bextra

(valdecoxib)

Bextra, which was launched by Pfizer in 2000, had sales last year of $687 million.

Bextra, the popular COX-2 inhibitor has been linked to heart attack, stroke, and Stevens Johnson Syndrome. Recent reports show that Bextra may be more likely to cause heart attack and stroke than Vioxx. Pfizer has recentley said they will most likely add a black box warning to Bextra about Stevens Johnson syndrome.

Symptoms of Stevens Johnson Syndrome are blistering, fever, cough, malaise, swelling, and lesions of gums, tongue, or lips, excessive tearing or "stickiness" of eyes and sores in the genital tract causing painful urination.

As of November 2004, the FDA has recieved 87 reports of that condition and other skin reactions. Thirty-six of the patients were hospitalized and four died, the FDA stated.

Prescriptions for Bextra, as of September 2004 were 1.48 million.

Traditionally, the number of reported injuries to the FDA were only 1% of actual incidences. So that number could be staggeringly high considering how long Bextra has been on the market.

The FDA is planning a public advisory committee meeting in February 2005, to discuss safety concerns with Bextra and other COX-2 inhibitors, including another Pfizer painkiller, Celebrex.