Finasteride, manufactured and marketed by Merck under the brand name Propecia, is used to treat male pattern baldness and benign prostatic hyperplasia, known as enlarged prostate. Male pattern baldness is a common condition in which men experience a gradual thinning of scalp hair, leading to a receding hairline or baldness on the top of the head. Propecia acts by blocking the body's production of DHT, the male hormone that impedes hair growth in the scalp. Studies have shown that although Propecia is effective in the treatment of mild to moderate hair loss, new hair growth is temporary. Clinical trials have shown that the hair growth gained by the use of Propecia is lost within six to nine months after the medication is discontinued.
Adverse side effects from Propecia include erectile dysfunction, impotence, decreased libido and male sterility. Serious symptoms may include breast enlargement and the development of lumps or swelling in breast tissue. Serious allergic reactions have been reported, characterized by swelling of the lips, eyes or face. Allergic reactions are usually temporary and are alleviated when the medication is discontinued. Extreme fatigue, drowsiness or confusion may be associated with depression or mental impairment, which has recently been associated with Propecia.
Propecia has been linked to permanent sexual side effects in men, including impotence, abnormal ejaculation, sexual dysfunction, erectile dysfunction, infertility, abnormal breast growth and prostate cancer. A recent study involving 71 healthy men who took Propecia revealed that over 90 percent suffered from sexual side effects, including sterility and sexual dysfunction; a far greater number than the 2% that Merck alleges in their literature. The study found that sexual side effects often remained even after the drug was discontinued.
In December 2008, the Swedish Medical Products Agency conducted an investigation regarding the safety and efficacy of Propecia, which resulted in conclusions that use of the drug can result in irreversible sexual dysfunction leading to infertility. Medical regulatory agencies in the United Kingdom, France and Italy updated Propecia safety warning labels to include information regarding the risk of potential permanent erectile dysfunction. In August 2011, Canadian regulators announced that Propecia warning labels would be revised to include information regarding the risks of male breast cancer. In June 2011, the United States Food and Drug Administration notified health care professionals that the Warnings and Precautions section of Propecia prescription labels would be revised to include information concerning the increased risk of high-grade prostate cancer.
Merck & Co, one of the largest pharmaceutical companies in the world, has come under intense scrutiny by regulatory and governmental agencies for allegations of fraudulent and illegal financial transactions. In 2002, the U.S. Department of Justice launched an investigation into Medicaid overbilling and fraud allegations after it was alleged by corporate employees that Merck failed to pay legal rebates to Medicaid and other health care programs. It was also alleged that Merck paid illegal sums to health care providers as financial incentives to promote the use various medications. In February 2008, Merck agreed to pay in excess of $650 million to settle federal charges stemming from overbilling Medicaid for medications.
It has been reported that as of March 2011, three class action lawsuits have been filed against Merck on behalf of men who suffered permanent sexual side effects after taking Propecia. A class action lawsuit filed in a Federal District Court in New Jersey alleges male sterility, sexual dysfunction and mental impairment directly caused by Propecia. It is alleged that Merck failed to disclose the risk of serious side effects associated with Propecia and failed to change warning labels in the U.S. after international regulators forced the company to change warning labels in several European countries.
Numerous individual personal injury lawsuits are currently pending in federal and state jurisdictions in the United States, alleging that men have suffered from prostate cancer, permanent sexual dysfunction and breast cancer as a direct result of Propecia.
Merck denies all allegations and has launched aggressive defenses to pending lawsuits. Merck refutes claims linking Propecia to permanent male sexual side effects and continues to actively market and promote the drug as a safe and effective treatment for male pattern baldness and prostate conditions. Recall petitions have been circulated by medical and legal professionals urging the FDA to take immediate action to remove Propecia from the U.S. market.