Taking more than 25 mg per day of rofecoxib (Vioxx) is linked to a tripling of the risk of heart attack, said a paper presented in August at the International Society for Pharmacoepidemiology Conference in Bordeaux, France.

Researchers analyzed data from the HMO Kaiser Permanente for all patients prescribed COX-2 inhibitors or non-steroidal anti-inflammatories. Patients on higher doses of rofecoxib increased their heart attack risk by a factor of 3.15. No increase was found in patients taking another COX-2 inhibitor, celecoxib (Celebrex).

Kaiser intends to re-evaluate use of this drug based on this information.

The manufacturer disagreed with the conclusions of the study.

“Observational analysis do not have the rigor of randomized, controlled clinical trials. … Based on the data that are available from our clinical trials, Merck stands behind the efficacy and safety, including cardiovascular safety, of Vioxx,” said Peter S. Kim, PhD, president of Merck Research Laboratories.



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