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The Food and Drug Administration has announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs (NSAIDs).
On April 7, 2005, the FDA issued a public health advisory and updated patient and health care practitioner fact sheets for COX-2 selective and prescription and non-prescription non-selective NSAID medications.
The FDA also asked Pfizer Inc. of New York City to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavorable. In addition, the agency asked Pfizer to include a boxed warning on the Celebrex (celecoxib) label.
Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussions with the agency. Pfizer also has agreed to work with the FDA on the boxed warning for Celebrex. The FDA has asked manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning, highlighting the potential for increased risk of cardiovascular events and gastrointestinal bleeding associated with their use.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," Steven K. Galson, M.D., acting director of the FDA's Center for Drug Evaluation and Research, said in announcing the changes. "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 maximizing their potential benefits and minimizing their risks."
Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for adverse events associated with the use of this class of drugs.
In addition, the FDA is asking the manufacturers of all non-prescription NSAIDs sold over the counter (OTC) to revise their labels to include more specific information about potential cardiovascular and gastrointestinal risks and information on the safe use of the drugs. The agency also is asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.
This current reexamination of the cardiovascular risks of NSAIDs began after Merck and Co. Inc. of Whitehouse Station, N.J., conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. The FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.
The actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis Drugs and Drug Safety and Risk Management Advisory Committees in February 2005.
A list of affected products is available at:
www.fda.gov/cder/drug/infopage/cox2/
FDA information number
(888) INFO-FDA (463-6332)