More heart risks found for COX-2 inhibitors

Cautionary information was released last month for two more drugs in this class.

By Susan J. Landers, AMNews staff. Jan. 3/10, 2005.

Washington -- More trouble was spotted in the family of medicines that includes the recently withdrawn Vioxx.

Pfizer Inc., which markets the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdecoxib), released new information on Dec. 17, 2004, indicating that Celebrex, like Merck & Co.'s Vioxx (rofecoxib), appears to pose an increased cardiovascular risk.

Meanwhile, new information on Bextra has placed it under a similar cloud of suspicion. Correspondence released early by the New England Journal of Medicine strongly cautioned doctors against prescribing Bextra "until there are convincing data supporting its cardiovascular safety."

The correspondence was to run in the journal's Dec. 23, 2004, issue.

Cautions about Celebrex surfaced when the National Cancer Institute stopped using the drug for all participants in a large colorectal cancer prevention trial after an independent analysis found there was an increased risk of major fatal and nonfatal cardiovascular events for participants taking the drug compared with those taking a placebo.

Patients in the trial who were taking 400 mg of Celebrex twice daily had 3.4 times greater risk of cardiovascular events than did those taking a placebo. For patients taking 200 mg of Celebrex twice a day, the risk was 2.5 times greater. Average duration of treatment in the trial was 33 months.

COX-2 drugs are being used in more than 40 National Institutes of Health studies for the prevention and treatment of cancer, rheumatoid and osteoarthritis, dementia and other diseases. The agency said it is currently re-evaluating their use.