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FDA adds new warnings to labels of Propecia, Proscar

Filed April 16th, 2012 Laurie

The Food and Drug Administration has added new warnings to the labels of the male-pattern baldness drug Propecia and the prostate drug Proscar to alert physicians and the public about the risk of permanent sexual side effects resulting from their use.

Both drugs contain finasteride as its Active Ingredient. It is sold at 1 mg doses as an approved treatment of male-pattern baldness and at 5 mg in the treatment of an enlarged prostate, a condition which could cause prostate cancer.

The FDA was compelled to enhance the warnings currently issued with the drugs after receiving numerous reports of men experiencing myriad forms of permanent sexual dysfunction, including erectile dysfunction and decreased libido. Prior to the agency’s decision last Thursday, warnings only indicated that possible sexual side effects would be temporary and eventually resolve themselves after a man stopped taking one of the drugs.

The side effects warnings were not the same in the U.S. as they were in Europe, where labels mentioned the possibility of permanent sexual side effects.

According to a report from Associated Press, the new warnings are specific to each drug. Labels on Propecia will now include warnings about the possible risk of “libido disorders, ejaculation disorders, and orgasm disorders” which continued after a man stopped taking the drug. It will also note the possibility a recipient experiencing infertility or “poor semen quality” that eventually improved after Propecia was stopped.

Warning labels on Proscar will note the risk of decreased libido and the same warnings of infertility and poor semen quality carried with Propecia.

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