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Physicians, patients decry COX-2 withdrawals: Bextra voluntarily withdrawn from the market; FDA wants black box warnings on all prescription NSAIDs.(Clinical Rounds)
The market withdrawal of valdecoxib and the black box warnings on celecoxib and all other remaining prescription NSAIDs have some physicians fuming and patients worried and confused, experts say.
"The American College of Rheumatology has been getting a lot of e-mails expressing anger and frustration," said ACR President Elizabeth Tindall, M.D. "We still feel that these drugs play an extremely important role. The fallout of this will be that patients either go off their medications without supervision, won't go on them even if indicated, or will be on them and have to listen to well-meaning family and friends telling them to get off. This decision has made caring for these patients even more difficult."
Rheumatologists are not the only physicians expressing alarm, said Dr. Tindall of Oregon Health and Science University, Portland. "The chronic pain societies have also been very concerned. They were rather pointed in their response, saying, 'What is left for pain, other than narcotics?'"
In addition to calling for valdecoxib (Bextra) to be voluntarily removed from the market (which Pfizer agreed to do), the Food and Drug Administration called for a black box warning about serious cardiovascular and gastrointestinal risks to be added to the labels of all prescription NSAIDs, including celecoxib (Celebrex). The FDA has also called for stronger warnings about potential gastrointestinal and cardiovascular risks to be added to the packages of nonprescription NSAID products. Aspirin is exempt from label revision because of its proven cardiac benefits.
"I am not surprised by this decision, but I am disappointed for my patients and the millions of others who have pain and arthritis," said John Cush, M.D., a member of FDA's arthritis drugs and drug safety and risk management advisory committee and chief of rheumatology and clinical immunology at Presbyterian Hospital of Dallas. "It seems their welfare is being put on the back burner. This will definitely have a chilling effect on patients and their doctors who need to use COX-2 drugs or NSAIDs."
He added that including all NSAIDs in the picture may result in unforeseen consequences. "The implications of this announcement on over-the-counter NSAIDs have not been delineated but may be significant."
In asking Pfizer Inc. to remove valdecoxib, the FDA went against the recommendation of its own advisory board. In February, the committee voted 17-13 to keep valdecoxib on the market, with a contraindication against its use in cardiac surgery patients.
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Source: HighBeam Research, Physicians, patients decry COX-2 withdrawals: Bextra voluntarily...