FDA launches a review of Propecia side effects


The U.S. Food and Drug Administration (FDA) has begun a safety review of Propecia (finasteride), a drug approved to treat baldness in men. The review follows numerous reports of sexual side effects, which are possibly permanent. While studies published last year have caused a recent stir, this information has been already been known to European users for several years.

Propecia, generically known as finasteride, is manufactured by Merck & Co. and prescribed in 1 mg doses to treat male pattern balding. In higher doses, it is marketed as Proscar and is approved to treat benign prostatic hyperplasia. Over the years, Merck has had to update Propecia’s label to include side effects such as depression, male breast cancer and most recently, sexual dysfunction.

In 2008, The Swedish Medical Products Agency found that the drug may cause irreversible sexual side effects. Merck was forced to change the label to include effects such as erectile dysfunction, a symptom that may persist even after treatment ends. US patients, however, were not officially informed of these effects until last year.

In the United States, Propecia came under fire last March, when the Journal of Sexual Medicine published studies identifying the sexual side effects of the drug. One study, led by Dr. Abdulmaged M. Traish, found that some users experienced side effects such as erectile dysfunction, reduced ejaculation and semen volume.
What was more disconcerting, however, were findings that these effects may last much longer than warned. Originally, Propecia’s warning label included the rare possibility of sexual side effects, stating that these symptoms would subside once the Propecia is stopped. Another published study, led Dr. Dr. Michael S. Irwig, contradicts this assertion. Dr. Irwig and his team interviewed 70 men who exhibited signs of sexual dysfunction up to 40 months after treatment ended. Furthermore, 20 percent of these men continued to experience side effects for 6 years or more.

Merck has been facing so much controversy over Propecia that it has actually pulled its safety warning from the official website.

Not surprisingly, there has been a good deal of litigation surrounding Merck. As a result, a multidistrict litigation (MDL) hearing has been scheduled. On March 29th in San Diego, California the U.S. Judicial Panel on Multidistrict Litigation will hear arguments to decide whether or not to consolidate multiple cases into one court.

In response to the mounting reports about irreversible side effects with Propecia, the FDA has launched a safety review of the drug. While launching an investigation is certainly a step in the right direction, Propecia users may feel that this move is long overdue. European regulators established these adverse effects 4 years ago, forcing Merck to update their labels in countries such as Sweden, the UK and Italy. These patients have been informed as early as 2008, leaving a number of US customers to wonder why they had to suffer the effects before something was done in their own country.