A new report has found that Propecia (finasteride) sexual side effects seen in some men may be permanent. This is not the first time similar links have been made with the popular hair loss drug.
The January issue of QuarterWatch discussed evidence discovered by consumer advocacy group, the Institute for Safe Medication Practices (ISMP), in the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) of permanent Propecia sexual side effect risks.
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.
“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.
ISMP reviewed 50,289 reports of fatal, disabling, or other serious injury received by the agency in the second quarter of last year. The advocacy discovered that 46 of the 61 serious adverse event reports for finasteride involved some type of sexual problem, said QuarterWatch. “[I]n 20 cases, the reports indicated a significant or persistent disability,” the study said. A reduction in sexual drive and sexual dysfunction were the most common side effects reported in pre-approval clinical trials conducted in the 1990s for Propecia and Proscar, QuarterWatch pointed out. Merck manufactures both Propecia and Proscar and has long maintained that a casual relationship has not been established between either drug and reported sexual side effects.
In 2011, the first product liability lawsuit was filed against Merck over Propecia and Proscar; federal claims against Merck have since been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of New York. According to the U.S. Judicial Panel for Multidistrict Litigation, 139 separate actions are pending in the Propecia MDL, said QuarterWatch.
As we’ve written, prior studies have reported potential links with Propecia to sexual side effects, including erectile dysfunction, diminished sex drive, and orgasm problems. Other recent research has 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:
- In 2010, the Journal of Sexual Medicine published a study 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.
- Last July, the Journal of Sexual Medicine published another study confirming the 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.
- Last August, the Journal of Clinical Psychiatry published a study 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% in the control group.
Last April, the FDA ordered 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.