Pitfalls on the road to drug safety

The recent withdrawal of rofecoxib (Vioxx) from the worldwide market has focused intense public scrutiny on drug safety. Although the US Food and Drug Administration monitors drug safety after product approval, some have raised concerns about whether this system, which relies primarily upon voluntary reporting of adverse drug effects, is adequate to protect the public from unsafe pharmaceuticals.

In his televised appearance before the US Senate finance committee on 18 November, Dr David Graham, associate director in the FDA's Office of Drug Safety, claimed his own agency was “incapable of protecting [the public]” from other dangerous pharmaceuticals (BMJ 2004;329: 1253). He then listed five drugs that he considered potentially unsafe—the acne drug isotretinoin (Roaccutane), the weight loss drug sibutramine (sold as Reductil in Britain and Meridia in the United States), the cyclooxygenase-2 inhibitor valdecoxib (Bextra), the lipid lowering drug rosuvastatin (Crestor), and the asthma drug salmeterol (Serevent).

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