Was the FDA Wrong to Approve Vioxx?

Vioxx (rofecoxib-NSAID) is an example of dangerously poor FDA regulation, according to the testimony of Sidney M. Wolfe, MD Director of the Public Citizen’s Health Research Group (HRG), before the Health Subcommittee of the House Energy and Commerce Committee Hearing on Current Issues Related to Medical Liability Reform on February 10, 2005.

"A study published more than four years ago showed a four to five-fold increase in heart attacks in people using Vioxx compared to those using naproxen. As a result, we asked FDA for a black box warning four years ago. Although such a warning would have greatly reduced the toll of tens of thousands of heart attacks occurring between then and Vioxx’s withdrawal, the agency, to the pleasure of Merck, rejected a black box and chose not to adequately warn the public. Many lives were thus lost," Wolfe stated.

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see also:

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