Propecia, a popular drug also known as the generic finasteride, has been used to treat male hair loss. Propecia is manufactured by Merck & Co., Inc. Although there is no cure for hair loss, Propecia can temporarily stop hair loss and regrow hair.
Propecia belongs to the 5-alpha-reductase inhibitor (5-ARI) class of drugs, which can reduce hair loss by blocking a hormone known as dihydrotestosterone (DHT). Propecia decreases DHT levels, which can help to stop hair loss and regrow hair. Propecia comes in tablet form and is taken daily. It is often used by young men who have experienced premature loss of their hair. Proscar is a stronger version of finasteride which is generally prescribed to older women who have enlarged prostates, but has also been used by patients who were seeking to save and money and chose to cut up the Proscar pills in order to ingest the equivalent of the lower dose of finasteride contained in Propecia in order to treat their baldness.
The label revision is based on the FDA’s review of two studies, which showed that the drug boosts the chances of developing “high-grade” prostate cancer.
Earlier this year, Merck & Co., Inc. requested the Food and Drug Administration (“FDA”) approve these drugs for use in preventing prostate cancer, but the FDA denied their request. Furthermore, the FDA recently revised the Warning and Precautions section of the drug labels to include new safety information on the increased risk of developing an aggressive form of prostate cancer. The label revision is based on the FDA’s review of two studies, which showed that the drug boosts the chances of developing “high-grade” prostate cancer.
Propecia has also been recently linked to sexual dysfunction. In March, researchers from the U.S. published a study in the Journal of Sexual Medicine that indicated the side effects of Propecia and similar drugs were linked to sexual dysfunctions in men.
This study indicates that 5-ARI drugs may cause the following:
• Loss of libido
• Erectile dysfunction
• Reduced semen production
• Growth of male breast tissue
The researchers also agreed that in some cases, these side effects appeared to be permanent, which is contrary to early warning labels which reassured young men that sexual side effects caused by the drugs would be temporary and would not persist after they stopped taking Propecia.
Numerous lawsuits have been filed in the U.S. and Canada against Merck & Co., alleging that finasteride, Propecia, and Proscar and the accompanying warning labels are defective and that the drug manufacturers were negligent in failing to properly warn male patients that serious sexual side effects caused by use of the drugs for only a few days could be permanent.
Brenda Fulmer is a shareholder at the law firm Searcy Denney Scarola Barnhart & Shipley in West Palm Beach and partners with Pasternack Tilker Ziegler Walsh Stanton & Romano in the litigation of drug and pharmaceutical mass tort cases. Ms. Fulmer graduated from the University of South Florida with a B.S. in Finance, and received her Juris Doctor degree cum laude from Stetson University College of Law. For the past 17 years, she has represented thousands of mass torts plaintiffs in both state and federal courts who have been injured by defective medical devices and drugs.