Frequently Asked Questions (FAQ) and answers about Propecia, an anti-baldness drug that has been linked to persistent sexual dysfunction in men.
Frequently Asked Questions (FAQ)
Does Propecia cause sexual dysfunction?
How many cases have been reported?
What sexual side effects are linked to Propecia?
What studies have linked Propecia and sexual dysfunction?
What is Post-Finasteride Syndrome?
Propecia (1-mg finasteride) is a prescription medication for the treatment of male-pattern baldness, also known as androgenetic alopecia. It is manufactured by Merck & Co. and was approved by the FDA in 1997.
In men with a genetic predisposition to baldness, the hormone dihydrotestosterone (DHT) binds to receptors in hair follicles on the top of the scalp. Over time, DHT hormones damages hair follicles and causes a receding hairline and permanent baldness.
Propecia is a 5α-reductase inhibitor (5-ARI). It works by blocking an enzyme that converts testosterone into DHT, which reduces levels of DHT by 65% or more within 24 hours.
The most common side effect — reported in at least 1% of patients — is decreased libido, erectile dysfunction, and ejaculation disorders.
- Sexual Dysfunction: In 2011, the FDA added “persistent erectile dysfunction” to the label. In 2012, the FDA added libido, ejaculation, and orgasm disorders to the list of persistent sexual side effects.
- High-Grade Prostate Cancer: In June 2011, the FDA warned about the risk of serious, aggressive prostate cancer that grows and spreads faster than low-grade prostate cancer.
- Depression: In March 2011, “depression” and “suicidal thoughts or behavior” were added to the label.
Clear causal links between Propecia and sexual adverse events have NOT been established.
The FDA received 421 reports of sexual dysfunction from 1998-2011. Of these, 59 reported sexual dysfunction that persisted at least 3 months after stopping Propecia. As of mid-2016, over 1,000 lawsuits had reported persistent sexual dysfunction.
- Erectile dysfunction (impotence)
- Libido disorders
- Orgasm disorders
- Poor semen quality
- Ejaculation disorders
- Decreased libido
In clinical trials, 36 (3.8%) of 945 men treated with Propecia reported at least one symptom of sexual dysfunction, compared to 20 (2.1%) on a placebo.
Post-Finasteride Syndrome is a group of symptoms that have been reported in men who stop Propecia. The symptoms include loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, dry skin, and tinnitus