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Propecia Safety Review Expanded By FDA

Relentless criticism continues to shroud the popular hair growth medication known as Propecia (generic: finasteride). Compounding the already ambiguous situation are several claims that suggest the use of Propecia may coincide with catastrophic complications such as persistent sexual disfunction, depression, and even the development of cancer. The severe nature of these claims have already caused regulatory agencies to further investigate the safety and efficacy of Propecia use. However, according to an article published in the Examiner (examiner.com), the U.S. Food and Drug Administration (FDA) has expanded its current safety review.

As a product of Merck & Co., Propecia was introduced in 1997. Following the appropriate regulatory actions, the FDA approved the use of Propecia 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, Propecia may not demonstrate a favorable risk/benefit profile. The hair growth medication may coincide with catastrophic side effects. Reports have surfaced suggesting that Propecia may be responsible for the development of persistent sexual dysfunction, otherwise being referred to as 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. Their findings, published in the Journal of Sexual Medicine, revealed a significant influx of persistent sexual dysfunction associated with the use of finasteride.

The results of studies such as this have served as a catalyst for Propecia concern. Furthermore, there has been an influx of consumer complaints reported to the FDA’s MedWatch system that have spurred an additional safety review. According to an article published on Examiner.com, “numerous men who say they have been affected by the permanence of Propecia’s severe side effects have been contacted by the Food and Drug Administration this week as the agency expands its safety review.”

The Influx of reports seen on the MedWatch system have seemingly caught the attention of the FDA. “Review of the database may suggest a signal of an unexpected safety issue or indicate that some individuals experience a known side effect of a drug with greater severity. FDA will carefully evaluate and analyze all reports that are available and take any necessary regulatory actions if warranted.”

The extended safety review conducted by the FDA is attempting to identify the safety and efficacy of Propecia. Doing so can potentially eliminate any further adverse event reporting and possible prevent individuals from experiencing sexual side effects. While there is no scheduled time for this review, results will surely have overwhelming ramifications on the future of Propecia products.

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 been injured by Propecia, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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