Merck & Co. and GlaxoSmithKline Plc (GSK)’s drugs for hair loss and enlarged prostate will carry new U.S. warnings about a low risk of being diagnosed with a more serious form of prostate cancer.
The Food and Drug Administration revised the prescribing information for Merck’s Proscar and Propecia and Glaxo’s Avodart and Jalyn based on the findings of two studies, the agency said on Jun. 9, 2011 in a statement. From 2002 to 2009 about 5 million men were prescribed one of these drugs, known as 5-ARIs, including almost 3 million men ages 50 to 79, the FDA said.
In March, London-based Glaxo abandoned efforts to expand use of Avodart to prevent prostate cancer after an FDA advisory panel said neither Avodart nor Proscar had a favorable risk- benefit ratio.
The advisers raised concerns that the drug was masking harmful tumors by lowering levels of prostate-specific antigen, a protein used to detect cancer in the blood.
“FDA believes that 5-ARIs remain safe and effective for their approved indications,” the agency said. Jalyn is a combination treatment for enlarged prostate that includes Avodart. Propecia, a drug for hair loss, contains the same active ingredient as Proscar from Whitehouse Station, New Jersey-based Merck
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