Commonly used to treat male pattern baldness, Propecia (generic: finasteride) has recently been linked to increased risks of sexual side effects, including erectile dysfunction, impotence, loss of libido and orgasm problems. Additionally, finasteride has been associated with increased risks of high-grade prostate cancer and male breast cancer.
UPDATE: Propecia Risks Highlighted in Men’s Journal Report
September 14, 2015 — Men’s Journal is warning about the risk of sexual dysfunction and other side effects from Propecia. Click here to read more.
July 7, 2015 — Men who used Propecia and experienced persistent sexual dysfunction may also be more likely to experience suicidal thoughts, according to a new study. Click here to read more.
April 17, 2015 — Nearly 750 lawsuits involving persistent sexual side effects of Propecia have been filed in a centralized federal litigation in New York. Click here to read more.
April 7, 2015 — 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), according to a new study. Click here to read more.
April 6, 2015 — Out of 34 clinical trials of Propecia, none adequately reported sexual side effects, according to an analysis published in JAMA Dermatology. Click here to read more.
Propecia: An Overview
Manufactured by Merck & Co., Propecia (finasteride) was FDA approved in 1997 for the treatment of male pattern baldness. It belongs to a group of drugs known as 5-alpha reductase inhibitors (5-ARI), which block the male sex hormone testosterone from being converted into dihydrotestosterone, the hormone primarily responsible for male pattern hair loss.
Unfortunately, recent research suggests that Propecia may cause persistent or even irreversible sexual side effects, including low libido, erectile dysfunction, decreased arousal and orgasm problems.
Additionally, finasteride and 5-ARIs have been linked to cases of male breast cancer and increased risks of high-grade prostate cancer.
Due to the severity of the symptoms associated with Propecia, you or someone you know who used Propecia and experienced permanent sexual dysfunction may want to contact a Propecia lawyer or attorney with The Clark Firm for a free consultation to discuss the potential for a Propecia lawsuit.
FDA Updates Propecia Warnings
April 11, 2012: Today, the U.S. Food and Drug Administration (FDA) announced that the agency will be updating Propecia labels to include more warnings about the risk of persistent, severe sexual side effects that do not resolve when Propecia is discontinued. After receiving hundreds of reports from men who were injured by Propecia, the new labels will warn about the possible risk of libido disorders, orgasm disorders, and ejaculation disorders. The FDA will also warn that while men are taking Propecia, they may have fertility problems and decreased quality of semen.
Signs and Symptoms of Propecia-induced Sexual Dysfunction
- Sexual side effects
- Erectile dysfunction (impotence)
- Loss of libido
- Orgasm disorder
- Body disfigurement
- Gynecomastia (growth of male breast tissue)
- Genital shrinkage
- Penile fibrosis
- Endocrine System Crash
- Emotional trauma
- Post-Finasteride Syndrome
- And more
FDA Warning on 5-ARIs and Prostate Cancer
On June 9, 2011, the FDA released a Drug Safety Communication stating that the agency had reviewed two large, randomized controlled trials — the Prostate Cancer Prevention Trial and the Reduction by Dutasteride of Prostate Cancer Events. The trials evaluated daily use of finasteride 5 mg for 7 years for the reduction in the risk of prostate cancer in 18,882 men at least 50 years of age.
The study found that overall the drugs decreased the chances of lower-risk forms of prostate cancer. These patients had a 26% overall lower risk of being diagnosed with prostate cancer, when compared to placebos.
However, there was an increased risk of high-grade prostate cancer with finasteride treatment, a more serious form of prostate cancer. High-grade prostate cancer occurred in 1.8% of finasteride, versus 1.1% of placebo users. High-grade prostate cancer is dangerous because it often grows and spreads to surrounding areas, often reappears, and is difficult to treat.
Finasteride and Male Breast Cancer
The 5-mg dose of finasteride, marketed as Proscar, has been linked to an increased risk of breast tenderness, gynecomastia (enlarged breast tissue) and male breast cancer.
In the 4 to 6 year Medical Therapy of Prostatic Symptoms study of 3047 men, there were 4 cases of breast cancer in men treated with Proscar, versus no cases in men using a placebo.
Currently, the exact relationship between finasteride and male breast cancer is unknown. Proscar was originally marketed to treat prostate enlargement and other prostate problems.
Drugs that belong to the 5-ARI class include:
- Propecia (finasteride, 1 mg)
- Proscar (finasteride, 5 mg)
- Avodart (dutasteride)
- Jalyn (dutasteride and tamsulosin)
Proscar, Avodart and Jalyn are FDA approved to improve symptoms of an enlarged prostate gland. Proscar and Avodart are also approved to reduce the risk of surgery or urinary retention related to an enlarged prostate.
The FDA approximates over 5 million men have received an 5-ARI prescription between 2002 and 2009. Of those, nearly 3 million were between the ages of 50 and 79.