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FDA reviewing safety of Propecia | Examiner.com

FDA spokesperson Sandy Walsh wrote in an email that, “The focus of the current review is the persistence of severe male sexual dysfunction after discontinuation of Propecia’s use. This review was prompted by routine drug safety surveillance.”

FDA’s safety investigation comes as a growing number of men say Propecia’s severe side effects have caused them to suffer persistent and permanent sexual dysfunction. While several European countries have required Propecia’s maker, drug-giant Merck & Co., to issue warnings regarding the drug’s irreversible side effects, this marks the first time the FDA has acknowledged it is reviewing the drug’s safety here.

Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. When prescribed in 5mg doses to treat enlarged prostate it is sold under the brand name Proscar. The FDA approved Propecia in 1997 and reports that Merck’s annual Propecia sales are over $400 million

via www.examiner.com

Last year, researchers from the George Washington University and Boston University medical schools published separate studies in the Journal of Sexual Medicine that reported Propecia’s persistent and permanent side effects. Those side effects include erectile dysfunction, impotence, greatly reduced libido, testicular pain, problems with orgasms and gynecomastia – an over-development of the male breast.

Last year, the FDA issued a new warning regarding Propecia’s link to high-grade prostate cancer -- the most aggressive and deadly form of the disease

March 27, 2012 in Propecia | Permalink


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