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Pfizer recalling its COX-2 inhibitor Bextra in United States, Europe
FDA also requiring new warnings be included with labels for all prescription and nonprescription NSAIDs.
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Pfizer Inc. is suspending sales of Bextra in the United States and Europe due to an increased risk of rare but serious skin reactions associated with the drug.
The recall complies with requests from the FDA and European authorities. Pfizer “respectfully disagrees” with FDA’s position, but agreed to suspend sales of Bextra (valdexocib) pending further discussions with the agency. The company is also in contact with other regulatory agencies around the world and plans to take appropriate measures based on those discussions, Pfizer officials said in a press release.
In addition to the recall, the FDA has asked all manufacturers of NSAIDs to include a boxed warning with drug labels to highlight the potential increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use.
The labeling changes affect all prescription and nonprescription medications classified as NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors and nonselective over-the-counter (OTC) drugs, according to the FDA.
The agency has also requested that all prescription NSAIDs include a medication guide with the label to help increase awareness of such potential adverse events. Labels for OTC anti-inflammatories must also now include the following:
- more specific information on CV and GI risks;
- additional information on safe use of the drugs; and
- a warning on potential skin reactions, which is already included with prescription NSAIDs.
The recall and labeling changes represent the latest action taken by the FDA since Merck & Co. voluntary recalled Vioxx (rofecoxib) worldwide in September 2004.
Although the Vioxx recall stemmed from an increased risk of CV events, Pfizer noted in its press release that the FDA believes the CV risk associated with Bextra could not be differentiated from that of other selective (COX-2) inhibitors.