Paul Tassin  |  July 6, 2015

Category: Legal News

Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

Propecia sexual side effects

A recent review of clinical trials of the active ingredient in the hair loss drug Propecia found they failed to adequately relay safety information about the drug’s risk of erectile dysfunction.

The report was authored by scientists from Northwestern University and published in the journal JAMA Dermatology. The ingredient in question is the drug finasteride, first approved by the FDA under the brand name Proscar in 1992. Back then, finasteride was a treatment for benign prostatic hyperplasia, not hair loss. It got approval in 1997 as a treatment for male pattern baldness, also known as androgenic alopecia, under the brand name Propecia.

How Does Propecia Cause ED?

Propecia (finasteride) works by inhibiting the action of an enzyme that converts testosterone into dihydrotestosterone, or DHT. In the sexual organs, this action helps reduce the size of an enlarged prostate.

The same action seems to reduce the progression of male pattern baldness. Men with that condition have higher levels of DHT in their balding scalp. Propecia decreases the concentration of DHT in that scalp.

However, research suggests that reducing the amount of DHT may also inhibit sexual function. That effect apparently was underreported in the clinical trials conducted to evaluate the efficacy and safety of finasteride, according to the authors of the new report.

Analysis Reveals Propecia Sexual Dysfunction Concerns

The authors’ meta-analysis covered information from more than 5,700 men who took finasteride in 34 different clinical trials. The authors say the information provided about the frequency, severity, and reversibility of sexual dysfunction during finasteride treatment was not adequate.

The study’s lead author questioned whether the conductors of the trials purposely withheld information about sexual dysfunction, or whether the tests conducted in the trials were simply not designed to produce data about that particular Propecia side effect. He expressed concern that people taking Propecia may assume it’s a safe drug when in fact there is not enough information available to make that determination. He also questioned whether the risk to benefit ratio is acceptable.

Merck, the manufacturer of Propecia, said in a response that it stands behind the results of the studies it conducted. The company insists the clinical trials were well-designed and the results appropriately reported to the FDA and other countries’ regulatory authorities.

FDA Requires Propecia Warning Label Update

No causal link has been established between Propecia and sexual dysfunction. However, the FDA has received hundreds of reports over the years of problems such as erectile dysfunction, abnormalities of semen, and other sexual dysfunctions.

Based on those reports, in 2010, the FDA required a change in Propecia’s labeling to include a warning about the risk of sexual dysfunction as a Propecia side effect. Some patients reported continuation of these side effects even after they discontinued using Propecia.

The current FDA-approved label for Propecia states that the most common adverse reactions to Propecia include: “decreased libido, erectile dysfunction and ejaculation disorder.” It also lists several different types of sexual dysfunction that Propecia users reported to continue even after they discontinued the drug. These dysfunctions include “erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality,” as well as testicular pain.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Propecia attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Propecia class action lawsuit is best for you. [In general, finasteride lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

Learn More

Get Help – It’s Free

Join a Free Propecia Class Action Lawsuit Investigation

If you or a loved one took Propecia, Proscar or finasteride and suffered sexual dysfunction, you may have a legal claim. See if you qualify by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

Oops! We could not locate your form.

We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.


Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.