Finasteride label to list more side effects

April 18, 2012

Finasteride, the main ingredient in Merck?s drugs Proscar, Propecia and generic equivalents, will now carry an expanded warning about lingering sexual side effects, the Associated Press reports.

Washington - Finasteride, the main ingredient in Merck’s drugs Proscar, Propecia and generic equivalents, will now carry an expanded warning about lingering sexual side effects, the Associated Press reports.

The Food and Drug Administration broadened the cautions for Propecia, a treatment for male pattern baldness, and Proscar, used to treat symptoms of enlarged prostate and reduce the risk of urinary retention.

Finasteride was already connected with sexual side effects, but the FDA added new warnings amid reports of lingering reactions after patients stopped taking the drug. Propecia will now caution users about possible libido, ejaculation and orgasm disorders persisting even after patients stopped using the drug. Proscar now warns users of potential decreased libido. Both drugs will also caution patients of the risk of male infertility and poor semen quality, which improved or normalized after patients ceased using the medication.

This is not the first revision to finasteride’s warning label. In June 2011, the FDA revised the drug’s label to reflect possible increased risk of a serious type of prostate cancer.

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