The Food and Drug Administration asked pharmaceutical behemoth Pfizer to withdraw its arthritis drug, Bextra, stating that “overall risk versus benefit profile for the drug is unfavorable.” The Business Standard reports:
The FDA said it had also asked Pfizer to include a safety warning on its Celebrex drug. Both Bextra and Celebrex are among the class of drugs called cox-inhibitors which have raised concerns of increased heart and stroke risk.
The FDA also said it would “carefully review” any proposal by Merck to resume sales of its Vioxx painkiller. Merck last September withdrew Vioxx, also a cox-2 anti-inflammatory drug, because of the safety concerns, although the company had hoped to consider resuming sales of the drug pending the FDA decision.
Pfizer issued a statement this afternoon, stating it would suspend sales of the drug:
Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA. Pfizer said it will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients. For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.
In addition, at the request of European regulators, Pfizer will also suspend sales of Bextra in the European Union. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions.
Nathan Novak at 12:32 pm
