Pfizer withdrew its painkiller Bextra from the market today at the request of the FDA, who said an increased risk of adverse cardiovascular and skin reactions outweighed the drug's benefits.
In a statement, Pfizer said it disagreed 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," the statement said.
Pfizer said it would explore options with the agency under which the company might be permitted to resume making Bextra available.
The suspension of Bextra is one outcome of a series of changes outlined this morning by Steven Galson, acting director for the FDA's Center for Drug Evaluation and Research (CDER)
Those changes include:
*A "black box" warning for Pfizer's Celebrex highlighting its risks of gastro-intestinal bleeding and cardiovascular adverse events.
*Added information to medication guides for all non-steroidal anti-inflammatory drugs (NSAIDs).
* The revision of information about the gastrointestinal and cardiovascular risks and adverse skin reactions to all over-the-counter NSAIDs.
The FDA said further advertising for drugs in the class would have to acknowledge carried risks. The agency also said it would be working to draft guidelines on promotion, including DTC advertising, in weeks to come.