FDA panel rejects expansion of drug label

The New York Times: A Food and Drug Administration advisory committee on Tuesday rejected a bid to change the labels of two drugs to say they can reduce the risk of prostate cancer. "If the drugs were approved for that purpose, they would be only the second class of cancer-prevention drugs on the market." But the committee declined to approve the labels for GlaxoSmithKline's Avodart (dutasteride) and Merck's Proscar (finasteride), citing "uncertainty about long-term consequences ... especially if the drugs would be used by hundreds of thousands of healthy people." Two large studies "found the drugs reduced the overall prostate cancer risk by about 25 percent," but also "found small increases in the incidence of higher-grade, riskier cancers, in men taking the drugs..." The drug companies argued that the drugs only increased the likelihood of detecting cancer if it was already present (Kolata, 12/1).

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This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.