Pfizer response on Bextra and Celebrex

As part of its quarterly earnings announcement, Pfizer answered a series of questions related to its drug portfolio. As expected, there is a complete section on its Cox-2 drugs, Bextra and Celebrex. After Bextra recall was announced and FDA asked the company to put a black box warning on Celebrex, analysts have been deeply concerned about Pfizer's ability to survive the legal battles.

One of the questions asked was, "What recent regulatory actions have been taken concerning the safety of prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2-specific medicines?"

Pfizer's response

"The FDA Arthritis and Drugs Safety Committee and the Risk Management Advisory Committee met jointly on February 16-18 to review COX-2-specific inhibitors and other non-steroidal anti-inflammatory drugs (NSAIDs). After evaluating a substantial body of clinical data regarding Celebrex and Bextra and weighing the benefits and risks of these products, the advisory committees recommended to the FDA that these medicines remain available to patients with revised labeling.

On April 7, 2005, the FDA announced its plans for changes to the warnings sections of labels of NSAIDs, including COX-2 medicines, sold either by prescription or over-the-counter. These labeling changes will include boxed warnings for prescription NSAIDs regarding potential cardiovascular, gastrointestinal, and skin-reaction risks. Pfizer will continue to work closely with the FDA to implement labeling revisions for Celebrex that ensure its appropriate prescribing and use.

The FDA also requested the suspension of Bextra sales and marketing, based on its assessment of an unfavorable risk/benefit profile due to the additional increased risk of rare, serious skin reactions compared to other NSAIDs, including Celebrex. While Pfizer disagrees with this assessment of Bextra, it has respectfully complied with the FDA’s request and began the process of suspending Bextra sales on April 7. Discussions between Pfizer and the EMEA, Health Canada, and several other regulatory agencies in early April have led to similar regulatory requests regarding Bextra. Pfizer, while disagreeing with these agencies, has complied with their requests for suspension of sales and marketing of Bextra.

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