Lawsuits are mounting against Merck & Company over its hair loss drug, Propecia. Allegations include long-term, sometimes permanent, sexual side effects.
Approved in 1997 to treat male pattern baldness, Propecia (finasteride 1 mg) is part of a class of drugs known as 5-alpha reductase inhibitors (5-ARIs). Propecia’s active ingredient can interfere with male hormones, including testosterone derivatives. In higher doses, the drug is sold under the brand name Proscar and is approved as a treatment for men with benign prostatic hyperplasia (enlarged prostate) or urinary problems.
Meanwhile, over 400 lawsuits are pending in state and federal courts over Propecia, says Lawyers USA Online, over allegations of side effects, such as loss of libido, erectile dysfunction, and infertility. More than 140 lawsuits have also been consolidated in multidistrict litigation in the U.S. District Court for the Eastern District of New York; over 50 cases in state courts in New Jersey have been consolidated, as well, says Lawyers USA Online. Plaintiffs allege Merck knew about the risks of ongoing side effects, pointing out that Propecia labels in other countries were changed as long ago as 2008 and mentioned those risks, Lawyers USA Online notes.
In April 2012, Merck changed its label warning to indicate that sexual problems may persist even after Propecia has been ceased, according to Lawyers USA Online. In fact, the U.S. Food and Drug Administration (FDA) ordered the new warnings for the Propecia and Proscar labels detailing possible long-lasting male sexual side effects associated with the drug. Until the FDA ordered that label change, warnings provided to U.S. users of the drug suggested that these problems typically resolve. As we reported previously, Merck changed the Propecia label in Europe several years ago to warn that the drug could lead to permanent erectile dysfunction.
A recent report on which we wrote found that Propecia sexual side effects seen in some men may be permanent, not the first time similar links have been made with the popular hair loss drug. QuarterWatch discussed evidence discovered by consumer advocacy group, the Institute for Safe Medication Practices (ISMP), in the FDA’s Adverse Event Reporting System (FAERS) of permanent Propecia sexual side effect risks. “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, QuarterWatch indicated.
Prior studies have also reported potential links with Propecia to sexual side effects, including erectile dysfunction, diminished sex drive, and orgasm problems and other research suggested that Propecia use is linked to depression. The potential complications were seen to possibly persist even years after treatment was stopped. Some study findings include:
The Journal of Sexual Medicine published a study in 2010 linking Propecia to persistent sexual dysfunction. The researchers interviewed 71 Propecia users who reported new-onset sexual side effects such as low sex drive, erectile dysfunction, decreased arousal, and orgasm problems. Participants used Propecia for an average of 28 months; persistent sexual side effects lasted an average of 40 months from the time the drug was discontinued. The Journal of Sexual Medicine published another study last year confirming these prior findings. According to the study, 96 percent of the men studied who experienced sexual side effects after taking Propecia continued to suffer from these symptoms one year after they stopped taking the drug.
The Journal of Clinical Psychiatry published a study, also in 2012, that linked Propecia to depression. For that study, researchers compared men who experienced sexual side effects for at least three months after taking Propecia to a control group who had male pattern baldness, no history of mental illness, and no exposure to Propecia; 75 percent of the Propecia group reported feeling symptoms of depression compared to 10 percent in the control group.