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FDA NSAID Warning
FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the market. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The boxed warning will highlight the potential for increased risk of cardiovascular (CV) events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations.
In reaching these decisions, FDA has carefully considered the available data on all of the NSAIDs. The Agency has also considered presentations, discussions, and votes from the joint public meeting of the FDA Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee held on February 16, 17, and 18, 2005 to discuss the CV safety concerns for these drugs along with their overall risk-benefit.
Specifically, FDA is requesting the actions listed below and will work closely with the manufacturers to ensure their timely implementation.
BEXTRA (valdecoxib tablets)
FDA has concluded that the overall risk versus benefit profile is unfavorable and has requested that Pfizer, the manufacturer of Bextra, voluntarily withdraw Bextra from the market. This request is based on:
- The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.
- Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use.
- Lack of any demonstrated advantages for Bextra compared with other NSAIDs.
Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency.
Patients currently taking Bextra should contact their physicians to consider alternative treatments.
CELEBREX (celecoxib tablets)
FDA has concluded that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients. Accordingly, FDA will allow Celebrex to remain on the market and has asked Pfizer to take the actions listed below.