The Food and Drug Administration recently expanded the warning label on a group of prostate drugs, over concerns they may increase the risk for developing a more serious, high-grade form of prostate cancer. The updated warning information extends to brands such as GlaxoSmithKline PLC’s Avodart, as well as Merck & Co.’s Proscar, both of which are currently approved as a treatment to shrink the prostate.

The announcement from the FDA was issued based on the findings of two studies in which approximately 27,000 men, ages 50 and older, used the drugs for several years. While the risk for developing high-grade prostate cancer among the men in the study was relatively low, the FDA concluded that doctors should still be made aware of such information.

Additionally, the revised warnings arrived on the heels of a December 2010 decision by the agency’s Oncologic Drugs Advisory Committee in which the group voted 17-0 that GlaxoSmithKline’s dutasteride and Merck’s finasteride should no longer be used as a treatment in the prevention of prostate cancer, due to the fact that the drugs are linked to a higher incidence of high-grade tumors.


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