FDA Had Pfizer Pull Bextra Because of Serious Skin Reaction Side Effects
Pfizer Inc. wants its arthritis drug Bextra returned to the U.S. market and plans to discuss with the FDA how it might do so in the future. Pfizer, the world's largest drug maker, suspended sales of Bextra in April 2005 after U.S. and European regulators said the risk of serious side effects from the prescription drug -- including Stevens Johnson Syndrome and other potentially fatal skin reactions -- outweighed the benefits of this painkiller.
Bextra is part of a class of drugs known as COX-2 inhibitors that also includes Pfizer's drug Celebrex and Merck & Co Inc.'s Vioxx, which was withdrawn last year due to increased risks of heart attack and stroke.
Pfizer issued a short press release statement on May 10, 2005 asserting that Bextra is an important treatment option for certain patient populations. Chairman and Chief Executive Hank McKinnell, elaborating on the company's statement in an interview with Reuters later that same day, said Bextra likely would return to the market because it was needed by patients. Mr. McKinnell, however, did not predict when Bextra might be available again to patients in the U.S.
"The agency is open to discussions" with Pfizer but continues to believe Bextra's risks outweigh its benefits," said FDA spokeswoman Kathleen Quinn in reply to questions about the Pfizer May 10 press release and subsequent comments by Mr. McKinnell.
- Read more about the Bextra recall
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(Posted by: Tom Lamb)