The speed at which the field of arthritis pain treatment has been transformed left many patients confused and dismayed.
"I don't think that anyone imagined we would be sitting here in April with Vioxx and Bextra gone, with a black-box warning for Celebrex and talking about the safety of NSAIDs that have been used for decades," said John H. Klippel, president of the Arthritis Foundation. "At the moment, the typical person with arthritis is left in a serious quandary."
Klippel said the foundation, which believes authorities have sometimes undervalued the benefits of the painkillers, is nonetheless emphasizing lifestyle changes, injectable medications and some food supplements for arthritis sufferers worried about doing without the pills that gave them relief.
In moving against Bextra, the FDA said it was concerned not only with possible cardiovascular problems but also with potentially fatal skin reactions experienced by a small but troubling number of patients. Galson said Bextra did not pose greater cardiovascular risks than Celebrex, Vioxx or other COX-2 inhibitors -- a subclass of anti-inflammatory drugs -- but had to be withdrawn because it carried the additional heightened skin risk.
Pfizer said that it is suspending Bextra sales in the United States and the European Union at the request of the FDA and European regulators but that it "respectfully disagrees" with the FDA's assessment and wants eventually to resume selling the drug. "For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," the company said in a statement.
In addition to requesting the withdrawal of Bextra, the FDA said it had asked Pfizer to revise the labeling of Celebrex to include a stern black-box warning and a guide to alert consumers to the increased risk of cardiovascular events, primarily heart attacks and strokes. The agency said it would require black-box warnings on all other prescription NSAIDs and wants manufacturers of similar over-the-counter drugs to include "more specific information about the potential [cardiovascular and gastrointestinal] risks," as well as a warning about potential skin reactions. That request applies to popular nonprescription painkillers containing ibuprofen (sold under brand names such as Motrin and Advil) and naproxen (Aleve).
Wood, the chairman of the FDA expert panel, supports these new warning requirements, but he said they should be different from those on the COX-2 inhibitors.
"We know from the data that Celebrex and other COX-2s carry cardiovascular and other risks, but we don't really know yet that the other non-steroidals do," he said. "They might, and we should be careful as we do more research, but we just don't know yet."
Sen. Charles E. Grassley (R-Iowa), a vocal critic of the FDA, said he was encouraged but remained skeptical of the agency.
"It will be good news if today's action, which goes further than the recommendations of the FDA's advisory panel, is a turning point and indicates a more independent Food and Drug Administration," he said. "What's happened with these painkillers has been a confusing saga for the people who need pain relief, and that can be attributed to systemic failures by the FDA and misplaced priorities of the drug industry."
