Study Finds Depressed Mood Among Propecia Users with Sexual Side Effects
Propecia (known generically as finasteride), a drug used to treat male pattern baldness, has been under scrutiny following reports that users have experienced persistent sexual side effects, even after discontinuing the medication. Merck, the manufacturer of Propecia, is facing lawsuits alleging that the company failed to warn about the risk of persistent sexual dysfunction. A recent study published in The Journal of Clinical Endocrinology analyzed characteristics of men who report persistent sexual symptoms after using Propecia, finding that they had depressed mood.
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Researchers at Harvard Medical School conducted the study because “Some men who use finasteride for hair loss report persistent sexual and other symptoms after discontinuing finasteride therapy.” The study tested to see if these symptoms were related to certain physiological characteristics, including androgen deficiency, decreased peripheral androgen action, or persistent inhibition of steroid 5α-reductase (SRD5A) enzymes. The authors compared Propecia users who reported persistent sexual side effects, Propecia users who did not, and healthy men who never used Propecia.
Although researchers did not find differences in androgen deficiency, decreased peripheral androgen action, or persistent peripheral inhibition of SRD5A, men with persistent symptoms had depressed mood. “Symptomatic finasteride users revealed depressed mood and fMRI findings consistent with those observed in depression.” authors wrote. “Men with persistent sexual symptoms after finasteride use had depressed mood and affect but no evidence of androgen deficiency or insensitivity, or persistent inhibition of 5α± reductase.”
Propecia Side Effects Lawsuits Consolidated into MDL
Propecia sexual side effects lawsuits have been consolidated into a federal multidistrict litigation (MDL) in the Eastern District of New York. Lawsuits allege that the baldness drug caused sexual dysfunction, and that Merck failed to warn about the risks. According to court records, bellwether trials have been selected in the MDL.
Lawsuits in an MDL have the same basic allegations. These cases are transferred to one court before one judge to streamline proceedings and make the legal process more efficient. The goal is to resolve complex litigation more quickly. Merck faces over 1,000 Propecia lawsuits, court documents show.
Propecia plaintiffs allege adverse events such as erectile dysfunction, decreased libido, genital shrinkage, infertility and problems with cognition. Lawsuits state that Merck updated the Propecia label in Europe in 2008, warning that sexual side effects may be permanent. They point out that the warning label in the United States did not reflect the risk of persistent sexual dysfunction until 2012.
Lawsuits selected as “bellwether cases” represent most of the litigation. These cases are the first to go before jurors, providing the first chance for both parties to try their legal arguments in court. Bellwether trials can affect the remaining litigation, depending on their outcome. For example, if bellwether trials in the Propecia litigation continually lead to large verdicts for the plaintiff, Merck may be inclined to settle the lawsuits instead of letting them go to trial.
Propecia Sexual Side Effects Background
Propecia contains finasteride as its main active ingredient. The U.S. Food and Drug Administration (FDA) approved finasteride in 1992 to treat men with an enlarged prostate. The drug was marketed under the brand name Proscar. Propecia contains finasteride in lower doses, and was later marketed for male pattern baldness. Plaintiffs in the litigation allege Merck marketed the drug as treatment for baldness without warning about its risks.
The FDA announced Propecia labeling changes in 2012. The agency warned that some sexual side effects may persist even after the drug is discontinued. In 2011, the FDA said that men may continue to experience erectile dysfunction after taking the drug. The 2012 update included other sexual side effects, including libido disorders, ejaculation disorders and orgasm disorders that persisted after stopping Propecia. The label was also updated to include reports of male infertility and poor semen quality, which improved once the drug was stopped.
“Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.” FDA stated.
A review of the FDA’s Adverse Events Reporting System (AERS) identified 421 reports of sexual dysfunction with finasteride between 1998 and 2011, the agency said. Among these reports, 59 said the sexual dysfunction persisted for at least three months after stopping Propecia. The adverse events included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders. Additionally, there were 251 cases involving semen quality with Propecia. However, only 13 contained enough information for the agency to analyze.
In 2013, the consumer safety group Institute for Safe Medication Practices (ISMP) noted sexual side effects of Propecia in its QuarterWatch report. The report stated that, “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 report found that 75 percent (46 of 61) of serious adverse events reported for finasteride during the second quarter involved a sexual side effect, with significant or persistent disability noted in 20 cases. “The proposition that these side effects might be persistent was supported by an FDA analysis of adverse event data and a published scientific paper that described a full range of sexual side effects in otherwise healthy men 21-46 years old that persisted for a mean of 40 months after ceasing treatment” the report noted.
In 2010 and 2012, the Journal of Sexual Medicine published studies linking Propecia to persistent sexual side effects. The 2012 study found that, among men who continued experiencing sexual side effects after taking Propecia, 96 percent continued to experience symptoms one year after stopping the drug.
Filing a Propecia Lawsuit
If you or someone you know suffered sexual side effects after taking Propecia, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).