Pfizer is asked to suspend sales of painkillerBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7496.862-a (Published 14 April 2005) Cite this as: BMJ 2005;330:862
In a move that took experts by surprise, regulatory agencies in the United States and Europe have asked the drug maker Pfizer to suspend sales of its cyclooxygenase-2 (COX 2) inhibitor valdecoxib (Bextra).
The US Food and Drug Administration's move comes less than two months after an advisory panel recommended to the FDA that the drug remain on the market (BMJ 2005;330: 440, 26 Feb).
Pfizer said it “respectfully disagreed” with the regulators' assessments of the risk-benefit ratio of the drug but agreed to “voluntarily” suspend sales.
Although the suspension of valdecoxib was welcomed by many experts, the decision by the FDA to go further than the European Medicines Agency by ordering “black box” warnings on all non-steroidal anti-inflammatory drugs drew criticism from a number of experts.
“To lump everything within a black box dilutes the message about COX 2s and sows confusion among practitioners and consumers,” said Dr Garret FitzGerald, professor of cardiology at the University of Pennsylvania. He added, “I think the FDA has oscillated from saying there is no problem with anything to saying there's a problem with everything.”
Dr Curt Furberg, a member of the FDA's data safety and risk management advisory committee, agreed with Dr FitzGerald, saying that although he was pleased with the decision to withdraw valdecoxib, important differences existed among the non-selective non-steroidal anti-inflammatory drugs. He said that in certain studies the drug naproxen performed better than other non-steroidal anti-inflammatory drugs, so it was wrong to lump all these drugs together.
Some of the experts seemed to disagree over why Pfizer had been asked to withdraw valdecoxib from the market. Dr Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said that there were concerns over rare but serious skin reactions (“F.D.A. announces strong warnings for pain killers,” New York Times, 8 April, nytimes.com/).
But Dr Alastair Wood, chairman of the FDA's advisory panel on COX 2 inhibitors, said that it was cardiovascular risk, not skin disease, that caused the panel to have concerns about valdecoxib's safety.