Upon reviewing 34 clinical trials on a popular hair loss drugs known as Propecia and Proscar (finasteride), researchers found that none of the studies sufficiently reported on the drugs’ sexual side effects.
Scientists at Northwestern University said in their report that the findings raise serious questions about the safety of Propecia and Proscar. The analysis is published in the Journal of the American Medical Association (JAMA) Dermatology in late March, according to YAHOO! News.
Propecia/Proscar was approved by the U.S. Food and Drug Administration (FDA) in 1992. The drug, which is manufactured by Merck, works by interfering with testosterone. It can also interfere with the sex lives of men by causing decreased sex drive, impotence and problems with ejaculation. Northwestern University researchers say none of these side effects have been properly studied, YAHOO! News reported.
“Not one of the 34 published clinical trial reports provided adequate information about the severity, frequency or reversibility of sexual adverse effects,” said the study.
The actual risk of developing sexual side effects, how long they may last, how severe they may be and whether those side effects remain after the drug is stopped is not known. The majority of studies on the duration of drug safety were one year or less, but approximately a third of men took the drug for more than one year, according to YAHOO! News.
“People who take or prescribe the drug assume it’s safe, but there is insufficient information to make that judgment,” said lead study author Steven Belknap, research assistant professor of dermatology and general internal medicine at Northwestern University Feinberg School of Medicine.
Belknap noted a number of questions raised by the study’s results, including the lack of adequate information concerning the severity and toxicity of sexual toxicity.
“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?” Belknap asked. “And most importantly, is the risk to benefit ratio of finasteride acceptable?”
The report was based on a meta-analysis including data from upwards of 5,700 men taking Propecia/Proscar, which was originally developed for the treatment of enlarged prostate, according to YAHOO! News.