Q&A on the FDA Actions for the COX-2 Inhibitors and NSAIDs
(Suspension of Sales and Marketing of Bextra)

FDA Regulatory Actions for the COX-2 Selective and Non-Selective Non-Steroidal Anti-inflammatory drugs (NSAIDs)

FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the nonsteroidal antiinflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications . A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.

After concluding that the overall risk versus benefit profile is unfavorable, FDA has requested Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) 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 cardiovascular (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.