PROPECIA

Propecia is a well-known oral prescription medication used for the treatment of hair loss in men, also known as androgenetic alopecia. Androgenetic alopecia is a genetic disorder that effects 70% of men at some point in their lifetime and approximately 35 million men in the United States. The active ingredient in Propecia is finasteride, a synthetic four-azasteriod compound. Finasteride lowers the level of androgens in men, such as testosterone. Essentially, finasteride prevents the conversion of testosterone to dihydrotesterone in the body, which has been implicated in the balding process.

Initially, finasteride was developed by Merck to treat benign prostatic hyperplasia (also referred to as benign enlargement of the prostate) via the FDA-approved prescription medication referred to as Proscar, which contains 5 mg of finasteride. During the Proscar clinical trials, researchers noted hair growth as a potentially lucrative side effect.

In December 1997, the FDA approved a 1 mg dose of finasteride for the treatment of hair loss in men. Accordingly, Propecia has allegedly been the first drug in history to effectively treat baldness in the majority of men who use it. Merck claims 90% of the one million men who have taken Propecia have either improved or maintained their hair loss.

At the time of FDA approval in 1997, Merck advertised that the side effects of Propecia were rare and would disappear once use of the medication was discontinued. Early clinical studies supported this notion—representing that less than 2% chance that Propecia would cause any sexual side effects.

Several studies have since revealed that sexual side effects were more common than originally reported by Merck. In 2003, Merck’s own study revealed 15% of patients taking the higher dosage medication, Proscar, reported sexual side effects within the first year of treatment. Merck, however, attributed these side effects to other factors unrelated to the drug.

In March 2011, a Boston University School of Medicine study published in the Journal of Sexual Medicine concluded that about 8% of men taking Proscar or Propecia suffered from erectile dysfunction and about 4% of men suffered from reduced libido. The study also showed that a percentage of men continued suffering from the side effects long after they had stopped taking Proscar or Propecia.

In June 2011, as part of another study published by the Journal of Sexual Medicine, Dr. Michael Irwig of George Washington University School of Medicine revealed a much higher risk of sexual side effects from finasteride. Dr. Irwig surveyed 71 regular Propecia users between the ages of 21 and 46 and found that 94% suffered from a low libido, 92% experienced erectile dysfunction, and 92% had decreased sexual arousal. Again, it was discovered that the sexual side effects could last after discontinuing Propecia use, and in some cases almost four years after ending treatment.

Also in June 2011, the FDA issued a safety announcement to healthcare professionals warning that finasteride was linked to an increased risk of high-grade prostate cancer. Approximately a year later, the FDA released its own study concerning Propecia. In that study, 14% of 421 Propecia patients suffered from persistent sexual dysfunction. The FDA did not conclude that a clear causal link existed between the sexual side effects and the drug, but required Merck to add warnings of these complications to Propecia’s label nonetheless.

In 2013, Dr. Michael Irwig circulated another study concerning finasteride. The study, published in the journal Alcoholism: Clinical & Experimental Research, involved standardized interviews of 83 healthy men who developed persistent sexual side effects associated with finasteride. Dr. Irwig collected medical histories, sexual function, and alcohol consumption before and after the patients took finasteride. The study exposed a 65% decrease in alcohol consumption after the men stopped treatment. Although it is unclear why the medication has this effect, Dr. Irwig told U.S. News and World Report that he believes the drug may alter the brain’s chemistry.

Since 2011, hundreds of lawsuits have been filed in state and federal court against Merck over injuries allegedly caused by Propecia. On April 16, 2012, the U.S. Judicial Panel on Multi-district Litigation consolidated all Propecia lawsuits filed in federal court into the Eastern District of New York assigned to Judge Brian Cogan.

Plaintiffs claim that: (1) Merck failed to take reasonable care in designing, testing, manufacturing and selling Propecia; (2) knew or should have known that Propecia increases the risk of persistent and permanent side effects, even after consumers discontinue use; (3) failed to provide adequate warnings and knowingly and recklessly omitted and concealed known risks from consumers and doctors; (4) inadequately labeled the drug prior to April 2011 by failing to disclose sexual dysfunction risks; and (5) knew that the scientific community and the public would rely on the drug’s label and the presumption that dangers did not exist, yet marketed the drug with inadequate warnings. The injuries include erectile dysfunction, reduced sexual sensation, reduced libido, infertility and cognitive impairment.