Propecia Studies Lack Information About Sexual Side Effects

Propecia Studies Lack Information About Sexual Side EffectsApril 6, 2015 — Zero out of 34 clinical trials involving the hair-loss drug Propecia provided adequate information about the severity, reversibility, or frequency of sexual side effects, according to a study published in JAMA Dermatology.

Of the 34 articles, none had adequate safety reporting, 19 (56%) had partially adequate reporting, 12 (35%) had inadequate safety reporting, and 3 (9%) reported that no adverse events occurred. The studies included data on 9,751 unique human participants. Over half of the studies were funded by the manufacturer of Propecia.

The active ingredient in Propecia, finasteride, was originally developed to treat enlarged prostate (prostatic hyperplasia) in older men. It works by inhibiting the conversion of testosterone into the more-potent 5α-dihydrotestosterone (5α- DHT), which reduces levels of 5α- DHT in the bloodstream by 70%.

These hormone changes could potentially lead to sexual adverse events, including decreased libido and erectile dysfunction, especially in younger men. The FDA has issued several warnings about sexual side effects based on adverse event reports from users.

Lead study author Dr. Steven Belknap, research assistant professor of dermatology and general internal medicine at Northwestern University Feinberg School of Medicine, said:

“Was this information obtained but then not included in published articles? Or, were these clinical trials performed in a way that simply didn’t capture this essential information? And most importantly, is the risk to benefit ratio of finasteride acceptable?”

The manufacturer of Propecia, Merck & Co., is facing hundreds of lawsuits accusing the drug-maker of failing to adequately warn about the risk. These men allege that sexual dysfunction is more common and severe than Merck admits, and when side effects occur, they can last for years.

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