Baldness drug Propecia and prostate drug Proscar get labeling change for sexual side effects

Posted by Paul NapoliApril 23, 2012 9:33 PM

The U.S. Food and Drug Administration (FDA) has announced that labeling for the prescription drugs Propecia and Proscar will be updated to include information about sexual side effects that could persist after discontinuing the drug.

Physicians prescribe Propecia (finasteride 1mg) for the treatment of male pattern hair loss and Proscar (finasteride 5mg) for treatment of symptoms of an enlarged prostate condition called benign prostatic hyperplasia (BPH). The pharmaceutical company Merck & Co., Inc. manufactures both drugs.

More than a million men have used Propecia since it came on the market in 1998.

Labeling changes include:

Previous Propecia labeling said sexual side effects were reversible and disappeared after discontinuation of the drug.

Dr. Anthony D'Amico, of Brigham and Women's Hospital in Boston, told HealthDay News that the revised labels contain "an important message that people need to hear."

Particularly because Propecia is used by 20- and 30-year-olds for hair loss and these are people of childbearing age, so if they are getting issues with fertility that a big issue, D'Amico said.

The FDA said the Propecia labeling change comes after reviewing 421 postmarketing reports of sexual dysfunction submitted to the agency between 1998 and 2011. In 59 cases, erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders persisted for at least three months after men stopped taking the drug. The agency also reviewed sexual dysfunction reports for Proscar that resulted in the labeling change.

Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs, the FDA said.

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Baldness drug Propecia and prostate drug Proscar get labeling change for sexual side effects