Tuesday, November 30, 2010

Issues seen with drugs to curb prostate cancer: FDA

FDA is concerned about new uses of existing prostate drugs: "WASHINGTON (Reuters) - U.S. regulatory staff have raised concerns about data for two drugs by GlaxoSmithKline Plc and Merck & Co Inc and their effect on reducing the risk of prostate cancer in certain men.

Both drugs are already approved to treat symptoms in men with enlarged prostate

Food and Drug Administration staff, in documents released ahead of a public advisory meeting on Wednesday, said overall, large trials for each of the drugs showed benefits after four years with Avodart and seven years with Merck's drug, Proscar -- mostly in men with certain grades of the cancer.

They noted that "neither trial was adequately designed and conducted to characterize the ultimate outcomes of interest," such as death. "In both trials, there was also an unexpected finding of an increased incidence of high-risk prostate cancers among men receiving" the drugs


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