Editor note: On 11/19/2001, the FDA approved Bextra (valdecoxib). On April 7, 2005, following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. Pfizer was asked to withdraw Bextra from the market by the FDA. See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
Dateline: November 11, 2004
Pfizer Stands Behind Bextra
According to a study presented at an American Heart Association (AHA) meeting on November 8, 2004 and reported in the New York Times (NYT), Bextra (Pfizer's arthritis medication in the class of drugs known as COX-2 inhibitors - the same class as Celebrex and recently-recalled Vioxx) has shown an increased risk of heart attacks and strokes. Pfizer reacted quickly to the claim about Bextra by calling the report "unsubstantiated and misleading".
The article in the New York Times (free login required) focused on a preliminary study of Bextra which pooled data from 5,930 patients taking part in 12 trials. The study found 2.19 times the number of heart attacks or strokes among patients given Bextra, compared with patients given placebos.
Pfizer said in a press release that the report about Bextra is based on information that has not been published in a medical journal or subject to independent scientific review. Pfizer maintains the study is backward-looking and simply reorganizes data about Bextra presented in other settings, grouping samples that were too disparate for conclusive results.
In contrast, the White et al. analysis published earlier this year in the peer-reviewed American Journal of Therapeutics stated that short-and intermediate-term treatment with Bextra was not associated with an increased incidence of thrombotic events (heart attacks or stroke) relative to nonselective NSAIDS or placebo in osteoarthritis and rheumatoid arthritis patients. This conclusion was based on evaluation of a clinical trials database that includes nearly 8,000 patients treated with Bextra for durations ranging from 6 to 52 weeks. A heart problem with Bextra appeared only in studies involving patients at very high risk for heart disease who were undergoing cardiac surgery. Pfizer disclosed that information about Bextra on October 15, 2004.
The Food and Drug Administration plans to convene an advisory committee in February 2005 to review the cardiovascular safety of all COX-2 inhibitors, which includes Bextra.
Related Resources
Source: News Release, Pfizer Statement on Bextra (valdecoxib), <http://www.pfizer.com/pfizer/are/news_releases/2004pr/mn_2004_1110.jsp>, November 10, 2004
First published: 11/11/2004
