The world’s largest pharmaceutical company, Pfizer, has taken the dramatic step of pulling its COX-2 pain reliever, Bextra (valdecoxib), from the market at the request of the US Food and Drug Administration, which said that the risks associated with the drug’s use outweighed its benefits.

The agency asked the drug behemoth to suspend sales of Bextra after evaluating the risk of developing rare but serious skin reactions – the firm added a warning to the drug’s label to highlight this risk late last year [[10/12/04c]]. Pfizer says it “respectfully disagrees” with the FDA’s conclusion, but says it will comply with the request and is exploring its options with a view to resuming marketing of the product. Sales are also being suspended in the European Union at the request of the continent’s regulatory agency, and the company is holding discussions with other regulators around the world.

The firm has also agreed to add a boxed warning to the label for another painkiller, Celebrex (celecoxib), to highlight potential cardiovascular risk. The agency has asked for this warning to be added to all COX-2s and all non-steroidal anti-inflammatory drugs, including older non-specific drugs such as ibuprofen and naproxen. The warning will also contain information regarding a gastrointestinal risk that is already included elsewhere in the products' current labels.

Pfizer’s share price dropped an unprecedented 5% in pre-market trading yesterday on the news, which comes almost two months after an FDA advisory panel recommended that both Bextra and Celebrex stay on the market in spite of an increased risk of heart attack [[21/02/05a]]. The agency had convened an advisory committee meeting after heightened concern over the safety of the COX-2 class of drugs in the wake of Merck & Co’s decision to withdraw its offering, Vioxx (rofecoxib), from the market last year [[01/10/04a]].

“Today’s actions protect and advance the health of the millions of Americans who rely on these drugs everyday,” said Steven Galson, acting director of the FDA’s center for drug evaluation and research. “[The] FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximising their potential benefits and minimising their risks.”

Pfizer said it was evaluating the operational and financial impact of the withdrawal, which comes just two days after the company announced a dramatic cost saving scheme [[06/04/05a]]. Bextra brought in 2004 sales of $1.3 billion dollars.

- Meanwhile, the FDA also said yesterday that it would carefully review any proposal from Merck to resume marketing Vioxx. The firm has already indicated that it would consider reviewing Vioxx’ future depending on the FDA’s decision [[18/02/05b]].