What is Propecia?
Propecia (generic: finasteride) prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. The drug is used to treat male pattern hair loss (MPHL) on the vertex and anterior mid-scalp area. Propecia is made by Merck & Co., and was approved by the U.S. Food & Drug Administration (FDA) in December 1997.
What’s the Problem?
Recent studies have found that Propecia may increase the risk of persistent sexual side effects, prostate cancer, male breast cancer, endocrine system failure and more. Men who were diagnosed with sexual dysfunction or cancer after using Propecia may be eligible for compensation through the filing of a lawsuit.
Propecia Side Effects
- Erectile dysfunction
- Reduced ejaculate volume
- Reduced sexual sensation
- Infertility / impotence
- Diminished or reduced libido
- Genital shrinkage
- Penile fibrosis (Peyronie’s Disease)
- Prostate cancer
- Male breast cancer
- Endocrine system failure
- Body disfigurement
- Psychological and emotional trauma
- And more
Propecia Sexual Dysfunction Study
A study published in the Journal of Sexual Medicine in June 2011 looked at the effects of Propecia on 71 healthy males between the ages of 21 and 46. After using the drug, the men reported developing severe sexual complications that persisted even after discontinuing treatment. Specifically:
- 94% developed low libido;
- 92% developed ED;
- 92% had decreased sexual arousal;
- 69% reported having problems achieving orgasm;
- The average number of monthly sexual encounters decreased from 25.8 to 8.8;
- The total sexual dysfunction score on a standardized test scale increased before and after treatment with Propecia.
The average duration of these side effects was 20 months, with about 20% of men experiencing effects that persisted for 6 years or more.
“This is the first trial to show this medication can cause persistent sexual side effects,” said Michael Irwig, co-author of the study. “And the risk needs to be known when men are contemplating taking the medication and doctors are prescribing the medication. … The looming question for all the subjects is whether their sexual function will ever recover.”
Pre-approval clinical studies conducted by Merck found that temporary ejaculation disorders may occur in about 2% of men who take Propecia. However, a study published in the Journal of Sexual Medicine in December 2010 found that the occurrence of ejaculation disorders may be significantly higher than previously believed, and may last much longer. The 3 types of ejaculation disorders linked to Propecia included retrograde ejaculation, premature ejaculation and retarded orgasm.
On June 9, 2011, the FDA issued a Drug Safety Communication indicating that Propecia and other 5-alpha reductase inhibitors may increase the risk for high-grade prostate cancer, particularly when used over an extended period of time. The warning followed FDA’s review of 2 large studies – the Prostate Cancer Prevention Trial (PCPT) and Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial – which found that 5-alpha reductase inhibitors reduced the overall risk of prostate cancer but increased the chances of developing high-grade tumors.
“The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer),” the warning said. “This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men.”
Male Breast Cancer and Gynecomastia
The risk of developing gynecomastia (abnormal breast tissue enlargement) and breast cancer from Propecia may be increased in men who use the drug for an extended period of time, according to the Journal of the National Cancer Institute. When finasteride inhibits DHT it alters the estrogen-to-androgen ratio, which may also increase the risk of male breast cancer and/or gynecomastia.
Reports to the FDA from June 1992 to February 1995 indicated that gynecomastia had been observed in 214 men who were treated with finasteride. Two of these men were also found to have invasive ductal breast carcinoma. Additionally, there was a higher incidence of gynecomastia in men who participated in the PCPT. The rate of gynecomastia was 426 (4.5%) of 9,423 subjects randomly assigned to the finasteride arm compared with 261 (2.8%) of 9,457 subjects in the placebo arm. There was 1 case of breast cancer in each arm of the trial.
Propecia Labels Updated to Include Sexual Side Effects Warning
On April 11, 2012, the FDA announced that warning labels of Propecia would be updated to include information about sexual side effects including libido, orgasam and ejaculation disorders that persist even after patients stop using the medications. The label changes followed the agency’s review of 421 sexual adverse events reported between 1998 and 2011. Of these, 59 patients reported that the problems lasted longer than 3 months after quitting finasteride. FDA also looked at 131 cases of erectile dysfunction and 68 cases of decreased libido associated with Proscar from 1992 to 2010.
“Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have not been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs,” the FDA said.
In April 2012, all federal Propecia sexual dysfunction lawsuits were consolidated into a multidistrict litigation (MDL No. 2331) in the U.S. District Court for the Eastern District of New York. There are currently more than 700 lawsuits pending in MDL 2331.
Over 200 additional complaints have been filed in state courts in New Jersey, where Merck is headquartered. The New Jersey Supreme Court has decided to centrally manage those suits. In March 2012, the New Jersey Superior Court assigned Judge Jessica Mayer to oversee the cases.
People injured by Propecia have alleged that Merck:
- Failed to take “reasonable care” in designing, testing, manufacturing and marketing Propecia.
- Knew or should have known that Propecia increases the risk of serious side effects, even after patients stop using the drug.
- Failed to adequately warn the public and medical community about the dangers of using Propecia.
- Inadequately labeled the medication before April 2011 by failing to disclose potential sexual side effects.
- Knew the public and medical communities would rely on Propecia labels and “the presumption that the dangers did not exist,” yet marketed the drug without proper warnings.
December 1997 – Approved by the FDA
December 19, 1997 – Propecia approved by the FDA
January – June 2009 – Journal of the National Cancer Institute finding
January – June 2009 – Journal of the National Cancer Institute determines that men who take Propecia for an extended period of time may be at an increased risk of developing gynecomastia and/or male breast cancer.
December 2010 – Journal of Sexual Medicine study published
December 22, 2010 – Study published in the Journal of Sexual Medicine finds that ejaculation disorders in Propecia users may be much more common than Merck reported in clinical trials.
June 2011 – Study findings
June 2011 – Study finds a large number of persistent sexual side effects in otherwise healthy men who took Propecia.
March 2012 – New Jersey lawsuits filed
March 2012 – Propecia lawsuits filed in New Jersey state courts centralized before Judge Jessica Mayer.
April 2012 – MDL formed
April 2012 – Federal Propecia lawsuits consolidated into a multidistrict litigation (MDL 2331) in New York.
April 2012 – Propecia labels changed
April 11, 2012 – Propecia labels changed to include sexual dysfunction warning.
- “Propecia Drug Approval Package”. U.S. Food & Drug Administration (FDA). December 19, 1997.
- “Finasteride induced Gynecomastia: Case report and Review of the Literature”. International Journal of Trichology. January-June 2009.
- “Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido and Erectile Dysfunction and Depression in a Subset of Patients”. The Journal of Sexual Medicine. December 22, 2010.
- “Persistent sexual side effects of finasteride for male pattern hair loss”. The Journal of Sexual Medicine. June 2011.
- “Questions and Answers: Finasteride Label Changes”. U.S. Food & Drug Administration (FDA). April 11, 2012.
- “ In Re: Propecia (Finasteride) Products Liability Litigation Transfer Order”. United States Judicial Panel on Multidistrict Litigation (JPML). February 6, 2015.
- “Prostate Cancer Prevention Trial (PCPT)”. Southwest Oncology Group (SWOG).