NEWARK (CN) - Nine men claim that Propecia (finasteride), Merck's drug for male pattern baldness, caused sexual dysfunction even after they stopped using it.
Merck pushes the drug as "a safe treatment with little risk," but the nine plaintiffs, from seven states and the District of Columbia, say finasteride "prevents the conversion of androgen testosterone to DHT (dihydrotestosterone) in the scalp leading to a reduction of hair loss," and that Merck "knew or should have known that DHT is a hormone critical to male sexual performance and functioning."
Merck states on its label that Propecia, for some users, can lead to "sexual dysfunction such as decreased libido, erectile dysfunction, ejaculation disorder and decreased ejaculate volume," the plaintiffs acknowledge.
But as recently as October 2010 the product monograph states that "resolution of these adverse reactions occurred in men who discontinued therapy with Propecia and in most who continued therapy," the complaint states, quoting from Merck's material.
The men say that after the Swedish Medical Products Agency in 2006 began "investigating reports of persistent sexual dysfunction side effects which continue in men despite discontinuing finasteride," Merck changed the Propecia label in Sweden, Italy and the United Kingdom to include "persistence of erectile dysfunction after discontinuation of treatment" as a side effect.
But Merck revised the U.S. Propecia product monograph in 2010 without including an "updated warning regarding the persistence of sexual dysfunction," the men say.
They claim the FDA has received a slew of complaints about sexual dysfunction from Propecia, and that many doctors, in the United States and Europe, have "publicly expressed concerns about patients who have permanent sexual, mental and physical side effects after discontinuing finasteride."
According to the complaint, a doctor at a men's health clinic in Michigan said: "I am just totally against finasteride. I have had so many patients that have come to me where that medication has destroyed their life. ... They take finasteride for even as short as a week and it destroys their lives. And they become depressed, weak, impotent and the problem is when they go off the drug their symptoms remain."
The men seek punitive damages for negligence, product liability and breach of warranty. They are represented by Alan Milstein with Sherman, Silverstein, Kohl, Rose & Podolsky of Moorestown, N.J.
Read the Top 8
Sign up for the Top 8, a roundup of the day's top stories delivered directly to your inbox Monday through Friday.