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FDA issues warning on BPH drugs

June 10, 2011 1:18 AM UTC

FDA said it updated the labels for 5-alpha reductase inhibitors to include information about an increased risk of high-grade prostate cancer. The agency said the risk "appears to be low." The change followed FDA's review of data from the Phase III REDUCE trial of Avodart dutasteride from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and the Prostate Cancer Prevention Trial (PCPT) of Proscar finasteride from Merck & Co. Inc. (NYSE:MRK). FDA said the trials showed an overall reduction in prostate cancer diagnoses in those taking the drugs due to a decreased incidence of lower risk forms of prostate cancer. However, the agency said both trials showed an increased incidence of high-grade prostate cancer. Proscar and Avodart are approved to treat benign prostatic hyperplasia (BPH). Other 5-alpha reductase inhibitors include GSK's Jalyn dutasteride/tamsulosin, also for BPH, and Merck's Propecia finasteride, which is approved for male pattern hair loss. ...