FDA Warns of Propecia and Proscar Sexual Side Effects

FDA Warns of Propecia and Proscar Sexual Side Effects

April 18th, 2012 // 12:56 pm @

Last week the U.S. Food and Drug Administration (FDA) followed up a new blood clot warning for some birth control medications with an announcement that the labels for Propecia and Proscar would be updated as well. These medications, which contain finasteride, have been linked to several sexual side effects in the men who take them.

Propecia, produced by Merck, is a baldness drug taken by men fighting hair loss. Proscar, also sold by Merck, is used to treat enlargement of the prostate gland. Both of these medications contain the active ingredient finasteride.

The U.S. National Library of Medicine explains that finasteride treats prostate enlargement or benign prostatic hypertrophy (BHP) by blocking “the body’s production of a male hormone that causes the prostate to enlarge.” Finasteride treats hair loss by blocking another male hormone in the scalp which prevents hair growth.

The new drug labels will warn users of these medications of possible “sexual adverse events,” including “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.” These labels will also report decreases in libido that continued even after men stopped taking the drug, as well as reports of male infertility which improved by discontinuing use of the medication.

The report notes that a “broader range of adverse effects than previously reported” has been seen in men taking these medications, despite the fact that a “clear causal link” has yet to be found. Nevertheless, the FDA announcement explains that patients and prescribers each need to be aware of the reports of adverse events in order to determine if this is the best treatment option.

The FDA goes on to explain that both Proscar and Propecia belong to the class of prescription drugs known as 5 alpha-reductase inhibitors. Proscar, which contains 5 mg of finasteride, received FDA approval in 1992. Propecia, which has 1 mg of finasteride, was approved in 1997.

Although only a small percentage of men taking this medication have reported these sexual side effects, the FDA has “notified healthcare professionals who would normally prescribe finasteride products—dermatologists, family practice professionals, internists and urologists—about FDA’s review of postmarketing reports and the label changes.”

Individuals currently taking the medication who have concerns regarding these label changes are encouraged to weigh the risks versus the benefits with their doctor. The FDA explains that patients should not stop taking this medication without speaking to their medical provider first.

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