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Bextra Pulled From Market in U.S. and Europe, Pfizer Says
Source: PR Newswire
Published: April 07, 2005
Bextra, the pain relief drug from Pifzer Inc., was taken off the market Thursday because the overall risk versus benefit profile for Bextra is "unfavorable," the Food and Drug Administration said.
Bextra belongs to a class of drugs called Cox-2 inhibitors, including Celebrex (made by Pfizer) and Vioxx (made by Merck & Company). All three painkillers have been amid controversy since September 2004, after Merck pulled Vioxx from the market because it was found to increase a patients' risk of heart attack and stroke after 18 months of use.
But unlike Vioxx, Bextra was taken off the market because of its potential to cause a rare but serious skin reaction, which is already disclosed on its label, Pfizer said.
In a statement, Pfizer said it disagrees with the FDA's position regarding the overall risk to benefit profile of Bextra. However, Pfizer agreed to suspend sales of Bextra pending further discussions with the agency.
For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options, Pfizer stated.
In addition, at the request of European regulators, Pfizer said it would suspend sales of Bextra in the European Union.
Read Full Story at PR Newswire