Some men who took the male pattern baldness drug Propecia have developed prostate cancer or male breast cancer. Others have filed lawsuits alleging that Merck & Co., Propecia’s manufacturer, failed to warn them about the drug’s potential to irreversibly destroy a man’s sexual function.
If you have taken Propecia and you believe that it caused you to develop breast cancer, or to suffer sexual dysfunction or some other negative side effect, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group, a Propecia law firm, knows this, and we want you to believe it.
Continue reading this page to learn how you might be able to collect compensation for medical bills, lost wages, pain and suffering, and other damages.
What Is Propecia and What Is It Prescribed For?
Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. (When finasteride is prescribed in 5mg doses to treat enlarged prostate–also known as benign prostatic hyperplasia or BPH—it is sold under the brand name Proscar).
The FDA approved finasteride as Proscar in 1992. In 1997, the FDA added male pattern baldness to the drug’s indications, and Merck began selling it as Propecia in 1mg tablets, down from 5mg used in Proscar. The pharmaceutical giant Merck currently sells and manufactures both Propecia and Proscar.
Propecia works by inhibiting a man’s production of 5-alpha reductase (5a-R)–a natural enzyme present in the scalp, skin, epididymis, and prostate gland that converts testosterone into dihydrotestosterone (DHT), which causes male pattern baldness.
Due to its intense influence on hormones, Propecia can cause severe birth defects in unborn children. Consequently, the drug’s label states that “women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.”
The Potential To Cause Male Breast Cancer and Prostate Cancer
According to Propecia’s drug label, in “rare cases,” male Propecia users (from a population of uncertain size) voluntarily reported having developed male breast cancer. And, in a 4- to 6-year Medical Therapy of Prostatic Symptoms study of 3,047 men, four users of Proscar (which is the name given to Propecia when it is sold in 5mg doses) developed breast cancer while none of the placebo users did. Two other studies, however, did not find a relationship, leading the FDA to comment that the connection between long-term Propecia or Proscar use and male breast cancer is still unknown.
In August 2011, the Canadian Broadcasting Company reported that Health Canada had received two reports of Proscar male breast cancer and an unknown number of Propecia male breast cancer. Like the FDA, Health Canada stated that it could not rule out a causal connection between Propecia and male breast cancer.
Users of a class of medications called 5-alpha reductase inhibitors (5-ARI), which includes Proscar, are at a one percent greater risk of being diagnosed with high-grade prostate cancer compared to patients who have never taken the drug. That’s according to two large, randomized controlled trials–the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial–which evaluated daily use of 5mg of finasteride versus placebo for 7 years.
The Potential To Cause Sexual Dysfunction
With regard to sexual side effects, Propecia’s label states that “a small number” (i.e., “less than 2%”) of Propecia users “reported one or more of the following: less desire for sex; difficulty in achieving an erection; and, a decrease in the amount of semen.”
On April 8, 2011, two men from Nevada and Texas who allegedly suffered these Propecia side effects filed a Propecia lawsuit against Merck in New Jersey, where the drug maker is headquartered. They allege Merck failed to warn them that Propecia could cause permanent sexual dysfunction.
Indeed, Merck didn’t update Propecia’s U.S. label to include “reports of erectile dysfunction that continued after discontinuation of Propecia” until April 2011. The company made this change after the March 11, 2011, publication of the Journal of Sexual Medicine, which featured research showing that Propecia and Proscar use is linked to depression and loss of sexual desire in men, and that these symptoms could be permanent.
In Europe, however, the connection between Propecia and Proscar and potentially permanent sexual side effects has been publicized for some time. In 2008, the Swedish Medical Products Agency (SMPA) advised users that Propecia could cause irreversible sexual dysfunction. That year, Swedish authorities compelled Merck to change Propecia’s Swedish label to include reports of “persistent erectile dysfunction” (also known as “post-finasteride syndrome” or “PFS”), according to Men’s Health. Shortly thereafter, authorities in Italy and the United Kingdom did too.
Additionally, a study appearing in the Journal of Sexual Medicine in July 2012 found that permanent sexual side effects related to Propecia use can be even more common. After studying 54 subjects at 14 months after ceasing the drug on average, the researcher found that 96 percent reported suffering from “persistent sexual side effects,” and 89 percent met the clinical definition of “sexual dysfunction.”
Potential Side Effects That Might Continue after Discontinuation of Use
On April 11, 2012, the FDA announced a Propecia drug label revision due to adverse event reports it received that related to the possibility that Propecia could cause sexual side effects after men stopped using it. The revised label includes the following three additions:
- Entries for libido disorders, ejaculation disorders, and orgasm disorders occurring after discontinuation of Propecia.
- An entry for decreased libido after ceasing Propecia use.
- An entry that described reports of male infertility and poor semen quality that normalized or improved after discontinuation of Propecia.
RLG’s Propecia Lawyers Will Make Things Easier
Despite all of the evidence that Propecia causes adverse side effects, the FDA has not issued a Propecia warning, and no Propecia recall is in effect. That doesn’t mean a Propecia user can’t file a suit against the Propecia’s manufacturer, however.
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Propecia lawyers at the Rottenstein Law Group do everything they can to streamline the process of helping you to obtain compensation for your injuries.
If you believe you have experienced adverse side effects as a result of taking Propecia, submit this simple secure form for a free and confidential evaluation of your eligibility to file a Propecia lawsuit.