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news.Pfizer has agreed to suspend sales of its arthritis drug Bextra in North America and Europe after regulators found the drug's risks warranted its withdrawal from the market. The company has also been asked to expand the warning label for its other Cox-2 inhibitor, Celebrex, in line with new FDA guidelines.
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The FDA told Pfizer that, although Bextra’s cardiovascular risk could not be differentiated from other non-steroidal anti-inflammatory drugs (NSAIDs), the additional, increased risk of rare but serious skin reactions associated with Bextra warrants its withdrawal.
Pfizer stated that, although it disagrees with the FDA’s position regarding the overall risk/benefit profile of Bextra, it will suspend sales of the medicine pending further discussions with the US regulator. In addition, Pfizer will also suspend sales of Bextra in Canada and in the European Union at the request of European and Canadian regulators.
Regarding, Celebrex, Pfizer said that it will work with the FDA to add expanded risk information to the product’s label following an FDA decision to require boxed warnings of potential cardiovascular risk for all Cox-2s and NSAIDs, including older non-specific drugs such as ibuprofen and naproxen. The boxed warning for all NSAIDs, including Celebrex, will also contain information regarding gastrointestinal risk.
In addition, the FDA is asking manufacturers of all over-the-counter NSAIDs to revise their labeling to include more information on the cardiovascular and gastrointestinal risks as well as a warning about potential skin reactions.