Label Revision Expands Sexual Side Effects Warning on Propecia and Proscar Products

Two of Merck’s flagship products have recently served as a catalyst for significant distain in the healthcare industry. Of particular concern to consumers are the side effects that have become associated with the use of both Propecia and Proscar. After having been the target of intense criticism in recent months, it seems as if the animosity aimed in Merck’s direction has been justified. Accordingly, the U.S. Food and Drug Administration (FDA) has expanded the warning label on finasteride products, acknowledging that some men who took them developed persistent sexual side effects.

Finasteride is the active ingredient found in both Propecia and Proscar. However, Proscar introduces patients to 5 mg doses of finasteride, where as Propecia includes a smaller dose consisting of 1 mg. While the active ingredient remains the same, their applications are entirely different. Propecia is indicated for the treatment of male pattern baldness on the vertex and anterior mid-scalp region. Subsequently, Proscar has been approved by the FDA to assist in the treatment of bothersome symptoms in men with benign prostatic hyperplasia (BPH), otherwise known as an enlarged prostate.

Finasteride belongs to a class of medications known as 5-alpha reductase inhibitors. As a 5-alpha reductase inhibitor, finasteride prevents the conversion of certain hormones. In treating male pattern baldness, Propecia prevents 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. In the treatment of BPH, Proscar works by preventing the excessive production of a particular male hormone that has an adverse affect on the prostate in concentrated amounts.

However, the mechanism of action responsible for the inhibition of such hormones may coincide with lasting complications. The introduction of a 5-alpha reductase inhibitor such as finasteride may result in the irreversible development of endocrine system failure. Post-drug reactions such as these have become synonymous with lowered testosterone, LH, and FSH hormone levels. Should the balance of hormones remain uneven, several common human functions may become hampered or even obsolete.

Of significant concern, is the recent association with finasteride-induced endocrine system failure and the development of persistent sexual side effects. Men who take Propecia or Proscar may experience a number of sexual side effects along with corresponding complications that may ensue.

The endocrine system is the system of glands, each of which secretes a type of hormone directly into the bloodstream to regulate the body. Unique to the endocrine system are substances known as hormones. These substances act as chemical mediators released from endocrine tissue into the bloodstream where they travel to target tissue and generate a response. Hormones regulate various human functions, including metabolism, growth and development, tissue function, and mood.

Any imbalance of chemicals within the endocrine system may comprise a given set of human functions. Unfortunately, Propecia and Proscar are believed to adversely affect testosterone, a hormone found in the endocrine system. A significant imbalance of testosterone may result in several persistent sexual side effects. Endocrine system failure may result in the following complications.

  • Prostate cancer
  • Genital shrinkage
  • Bodily disfigurement
  • Gyneocomastia
  • Penile fibrosis
  • Depression
  • Low libido
  • Problems with ejaculation
  • Impotence
  • Testicular pain
  • Prolonged erectile dysfunction
  • Male breast cancer

Due to the increased rate in which these complications have occurred following finasteride treatment, the FDA has expanded the warning label on Propecia and Proscar, acknowledging that some men who took them developed persistent sexual side effects. Subsequently, 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 Finasteride 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 finasteride lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has suffered from persistent sexual dysfunction after taking Proscar or 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-(949) 557-5800.