The US Food and Drug Administration on 23 December 2004 urged doctors to curtail prescriptions of Celebrex and Bextra, two Pfizer-made drugs in the Cox-2 inhibitor class of painkillers, citing evidence of elevated cardiovascular risk.
The agency said all three Cox-2 drugs, including Vioxx, may raise the likelihood of serious heart attacks and strokes, especially with prolonged use or in patients recovering from heart surgery. Merck had already withdrawn Vioxx from the market in September 2004 for the same reason, leaving only the two Pfizer drugs available.
The FDA said Cox-2 drugs should be confined to patients at high risk of gastrointestinal bleeding, those unable to tolerate traditional anti-inflammatory painkillers, or those who have not responded to them.
A National Cancer Institute prevention trial was suspended after finding that patients taking 400 milligrams of Celebrex twice daily faced a 3.4 times greater risk of cardiovascular events than those on placebo; patients on 200 milligrams twice daily faced a 2.5 times greater risk. The FDA ordered a broad review of all prevention trials involving the two drugs.
Pfizer suspended advertising for Celebrex but said it would continue sales. A Canadian law firm filed a class action worth approximately 1.2 billion US dollars against Pfizer, on behalf of a Mississauga woman who alleged the drug caused her heart problems.
Historical summary. TurkishPress restated this AFP wire report, first published in December 2004, in its own words.