.Propecia and Proscar Label Change Reflects Increased Risk of Persistent Sexual Side Effects

In continuing with recent tradition, discontent persists to fester in those who have been affected by two of Merck’s most prominent products. Subsequently, both Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) have recently been associated with the development of persistent sexual side effects. In response to these findings, officials at the U.S. Food and Drug Administration (FDA) have announced that changes will be made to the professional labels of Propecia and Proscar in order to expand the list of adverse sexual events.

While Propecia and Proscar utilize the same active ingredient, finasteride, their dosages are indicated for the treatment of two independent conditions. Propecia, having already received the FDA’s approval in 1997, contains 1 mg of finasteride and is intended to assist in the treatment of male pattern baldness as it pertains to the vertex and anterior mid-scalp region. However, Proscar was released in 1992 and consists of 5 mg of finasteride. The larger dosage in Proscar has been approved by the FDA to assist in the treatment of bothersome symptoms in men with benign prostatic hyperplasia, otherwise known as an enlarged prostate.

The occurrence of sexual side effects had already been reported by patients during clinical trials, and the subsequent complications had already been included on the Proscar and Propecia labels at the time of their approval. Furthermore, Propecia and Proscar labels had already been revised once to include the increased risk of erectile dysfunction in 2011.

In continuing with their efforts to protect consumers, the FDA reviewed 421 postmarketing reports of sexual dysfunction submitted to the Agency’s Adverse Events Reporting System (AERS) database between 1998 and 2011. As a result, 59 cases indicated signs of sexual dysfunction that lasted for at least three months following discontinuation of Propecia, and included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders.

In addition, the FDA conduction a review of adverse events that had been associated with the use of Proscar as well. The FDA reviewed 131 cases of erectile dysfunction and 68 cases of decreased libido associated with the use of finasteride 5 mg submitted to the drug sponsor’s worldwide safety database between 1992 and 2010. Where information was available, these reported events of erectile dysfunction and decreased libido lasted for at least several weeks after drug discontinuation.

Further complicating the already ambiguous situation, is a study that was recently published in the Journal of Sexual Medicine. According to the study, 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.

In response to several clinical trials and an influx of adverse sexual health reports, the FDA has announced significant changes that will be made to both Propecia and Proscar labels. The new label changes include:

  • A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
  • A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
  • A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

Do I Have a Proscar or 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 Proscar and Propecia lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has experienced sexual side effects after taking Propecia or Proscar, 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.