Sexual dysfunction is the most common side effect of Propecia, an anti-baldness medication. In some cases, impotence and other sexual disorders persist long after men stop taking the drug. Over 1,000 lawsuits have been filed against Merck & Co. for failing to warn about the risk.
Propecia Risks Highlighted in Men’s Journal Report
In 2012, federal judges created a Multi-District Litigation (MDL) in the Eastern District of New York to centralize Propecia lawsuits. About 750 caseswere filed by mid-2015, and over 1,000 have been filed as of mid-2016. Hundreds of additional lawsuits are pending at the state level in a New Jersey Multi-County Litigation (MCL).
Propecia (1-mg finasteride) was approved by the FDA in 1997 for the treatment of male pattern baldness. It is manufacutred by Merck & Co.
How Does Propecia Work?
Propecia is a 5-alpha reductase inhibitors (5-ARI) that blocks male sex hormones. Specifically, it reduces the amount of testosterone that is converted into dihydrotestosterone (DhT), a male sex hormone that is primarily responsible for male pattern hair loss.
What is the problem?
In clinical trials, sexual dysfunction was the most commonly-reported side effect of Propecia. About 3.8% of 945 men on Propecia reported at least one symptoms, compared to 20 (2.1%) on a placebo. In some cases, these problems do not improve when men stop using Propecia.
FDA Updates Warnings
In 2011, the FDA added “persistent erectile dysfunction” to the list of Propecia side effects based on hundreds of adverse event reports. In 2012, the FDA issued a Safety Communication and expanded the list of sexual side effects.
Sexual Side Effects of Propecia
- Erectile dysfunction
- Libido disorders
- Orgasm disorders
- Poor semen quality
- Ejaculation disorders
- Decreased libido
Does Propecia Cause Sexual Dysfunction?
No clear causal links between Propecia and sexual side effects has been established. However, these case reports suggest a broader range of adverse effects than previously reported by Merck & Co.
Propecia and High-grade Prostate Cancer
In June 2011, the FDA waarned that Propecia may increase the risk for the most serious form of prostate cancer. These high-grade tumors are the most deadly form of prostate cancer. They grows and spread into surrounding areas quickly, often reappear, and are hard to treat.
Studies of Propecia Sexual Dysfunction
Out of 34 clinical trials of Propecia, none adequately reported sexual side effects, according to a study published in JAMA Dermatology.
In 2015, another study found that men under 42 years old who use Propecia are significantly more likely to be diagnosed with erectile dysfunction, low libido, and need to take medications like Viagra (sildenafil).
Men who used Propecia and experienced persistent sexual dysfunction may also be more likely to experience suicidal thoughts, according to study published in Pharmacotherapy.