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Propecia Lawsuits Mount Over Persistent Sexual Side Effects

Apr 5, 2013

Lawsuits continue to mount against drug maker Merck & Company over its hair-loss medication, Propecia, and include allegations involving long-term sexual side effects that, in some cases, are permanent.

Propecia (finasteride, 1 mg) was approved in 1997 to treat male pattern baldness and is part of a class of drugs known as 5-alpha reductase inhibitors (5-ARIs). Propecia’s active ingredient is known to interfere with male hormones, including testosterone derivatives.

In higher doses, finasteride is sold under the brand name Proscar, and has been approved to treat men with benign prostatic hyperplasia (enlarged prostate) or urinary problems.

To date, over 400 lawsuits are pending in state and federal courts over Propecia. These lawsuits allege that the side effects include loss of libido, erectile dysfunction, and infertility.

Last April, Merck agreed to change its label warning to indicate that sexual problems could possibly persist even after Propecia treatment has been stopped, said Lawyers USA Online. The stronger warnings were ordered by the U.S. Food and Drug Administration (FDA), for both Propecia and Proscar labels.

Until the FDA ordered the label change, prior warnings suggested that the side effects typically disappeared once the medication was stopped. However, several years ago, Merck changed the Propecia label in Europe to warn that the drug could lead to permanent erectile dysfunction.

More than 140 lawsuits have been consolidated in multidistrict litigation in the U.S. District Court for the Eastern District of New York and over 50 cases in New Jersey state courts have been consolidated. Plaintiffs in these cases allege that Merck was aware of the risks of ongoing side effects, pointing out that Propecia labels in other countries were changed as far back as 2008 and included mention of those risks, Lawyers USA Online noted.

A recent report revealed that Propecia-related sexual side effects in some men may be permanent— but this is not the first time hair-loss medication has been linked to the condition. Consumer advocacy group The Institute for Safe Medication Practices (ISMP), in the FDA Adverse Event Reporting System (FAERS), found evidence of persistent Propecia side effects.

“Nearly 20 years after approval, evidence is now emerging that the sexual side effects of finasteride may sometimes be irreversible and were most notable in the younger men taking finasteride for male pattern baldness,” the ISMP study said, wrote QuarterWatch.

Prior studies that have reported potential links between Propecia and sexual side effects also have included diminished sex drive and orgasm problems, in addition to erectile dysfunction. Other research has suggested that using Propecia is associated with depression. Potential complications were seen to possibly persist for years after treatment was stopped.

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