FDA To Conduct Further Propecia Safety Reviews

Amidst growing concerns of severe Propecia side effects, consumers are being led to believe that the popular hair growth treatment may not demonstrate a favorable risk/benefit profile. A growing number of men have begun to report signs of persistent sexual dysfunction after discontinuing Propecia treatment. According to a spokeswoman from the U.S Food and Drug Administration (FDA), the agency has taken these reports into consideration and is currently conducting a safety review of Propecia.

Propecia was introduced to the U.S. market in 1997 by the global pharmaceutical powerhouse Merck & Co. Upon its release, Propecia gained approval by the U.S. Food and Drug Administration (FDA) to treat male pattern baldness on the vertex and the anterior mid-scalp area.

Finasteride, the active ingredient contained within Propecia, belongs to a class of medications known as 5-alpha reductase inhibitors. As a 5-alpha reductase inhibitor, finasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) in the scalp, which prevents hair growth. DHT is a substance in the body that can shrink hair follicles until they no longer produces visible hair. Accordingly, Propecia’s mechanism of action has proven capable of re-growing hair by restricting the production of DHT.

Unfortunately, this mechanism of action may also coincide with severe side effects as well. Increasing reports are associating Propcia with the development of persistent sexual dysfunction, in what professionals have dubbed Post-Finasteride Syndrome. In order to determine the safety and efficacy of Propecia, researchers conducted standardized interviews with 71 otherwise healthy men aged 21–46 years who reported the new onset of sexual side effects associated with the temporal use of finasteride.

Acording to the study, published in the Journal of Sexual Medicine, subjects reported new-onset persistent sexual dysfunction associated with the use of finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after finasteride use according to the Arizona Sexual Experience Scale (P < 0.0001 for both). The mean duration of finasteride use was 28 months and the mean duration of persistent sexual side effects was 40 months from the time of finasteride cessation to the interview date.

In response to the growing number of adverse events being reported to the FDA’s MedWatch program, the agency has decided to conduct additional Propecia safety reviews. When undertaking such an investigation, the FDA monitors Adverse Event Reports (AERs) collected from the MedWatch website, a place in which consumers have been instructed to report any adverse effects resulting from the use of medications. In the event that the site receives numerous reports, as we have recently seen with Propecia, the FDA may conduct further safety reviews. In an email, spokesperson Sandy Walsh acknowledged that “the focus of the current review is the persistence of severe male sexual dysfunction after discontinuation of Propecia’s use.”

In explaining the adverse Propecia reports, Walsh also noted that the “FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.” The appearance of Propecia in such reports labels it as a potential safety issue, therefore leading to further investigation.

The results of further investigations may have overwhelming ramifications on the current safety and efficacy labels currently marketed with Propecia.

Do I Have a Propecia Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Propecia lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has developed persistent sexual dysfunction, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.