Vioxx and Bextra - what's the problem?

This month, October 2004, has seen the withdrawal of a drug and the adding of a warning to another drug that were both used for arthritis treatment and painkillers - Vioxx® (Merck - rofecoxib, withdrawn) and Bextra® (Pfizer - valdecoxib, warning). Merck states that "there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo". As a result, it announced the withdrawal of Vioxx.

Pfizer states that "in two trials in a high-risk surgery known as coronary artery bypass graft (CABG), an increase in cardiovascular events was observed in patients receiving Bextra alone or in combination with parecoxib".

Dr. G. A. FitzGerald, writing in the New England Journal of Medicine (v 351, p 1709, 2004) states that "The rofecoxib story ... reflects poorly on the process that leads to drug approval". He states that there was a clear rationale for addressing cardiovascular effects of these types of drugs; however, the questions were never addressed directly.

In our opinion, the problem lies in part with the need for much larger studies, in itself making the drug approval process more time consuming and expensive. Ideally, drugs should be continually tracked after they are marketed, and they should initially be prescribed only for those who absolutely need them. One way to do this is to report adverse reactions to the FDA. While they haven't always been particularly proactive on followup, it still provides some assistance in determining problems with drugs.

Click here to report an adverse reaction to the FDA.

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Last Modification - October 16, 2004