Some men who took the drug Proscar, which is prescribed for enlarged prostate, have developed male breast cancer. Others allege that Merck, Proscar’s manufacturer, failed to warn them about the drug’s potential to irreversibly destroy a man’s sexual function.
What Is Proscar and What Is It Prescribed For?
Proscar is the brand name for the drug finasteride when it is prescribed in 5mg doses to treat enlarged prostate. (When finasteride is prescribed in 1mg doses to treat male pattern baldness it is sold under the brand name Propecia). Originally developed by Merck in the mid-1970s to treat benign prostate hyperplasia (enlarged prostate), finasteride wasn’t indicated for male pattern baldness by the FDA until 1997, at which point Merck began selling it as Propecia in 1mg tablets, down from the 5mg used in Proscar.
Due to its intense influence on hormones, Proscar can cause severe birth defects in unborn children, and women are advised to avoid contact with Proscar pills and Propecia pills.
The Potential To Cause Male Breast Cancer and Sexual Dysfunction
The drug label for Propecia, which is simply another name for Proscar, reports that users of 1 mg Propecia informed the FDA that the drug caused male breast cancer. Indeed, in the Medical Therapy of Prostatic Symptoms study of 3,047 men, four Proscar users developed breast cancer while none of the placebo users did. Two other studies, though, did not find such a relationship, leading the FDA to comment that the connection between long-term finasteride use and Proscar 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 finasteride and male breast cancer.
Reports of Proscar’s sexual side effects started appearing in 2008 when the Swedish Medical Products Agency (SMPA) advised users that the drug could cause irreversible sexual dysfunction. In 2009, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom required a label change on Propecia warning that the potential for the drug to cause male breast cancer in 5mg doses could not be ruled out.
In the March 11, 2011, issue of the Journal of Sexual Medicine, Boston University researchers linked Propecia and Proscar to depression and loss of sexual desire in men. Other Proscar side effects include growth of male breast tissue, reduced semen production, and erectile dysfunction. Moreover, the researchers found that these symptoms could be permanent even after men stopped taking the drug.
On April 8, 2011, two men from Nevada and Texas filed a Proscar lawsuit against Merck in New Jersey, where the drug maker is headquartered. They allege Merck failed to warn them that Proscar could cause permanent sexual dysfunction even though, in Europe, Proscar’s labels contain such warnings due to the SMPA’s 2008 investigation. They also allege negligence, strict product liability, and breach of warranty. The plaintiffs demand $100,000 in compensation plus punitive damages.
In response to increased data on Proscar side effects, the FDA released a Proscar warning in a drug safety communication dated June 9, 2011. The FDA acknowledged a possible link between Proscar and prostate cancer. It announced a change in the “Warnings and Precautions” section of the drug’s label, informing health care providers that Proscar had been linked to high-grade prostate cancer.
Later, in April 2012, the FDA again announced a Proscar label revision due to adverse event reports related to Proscar sexual side effects that occurred even after men stopped taking the drug. The revised label includes the following three additions:
- Entries for libido disorders, ejaculation disorders, and orgasm disorders that occurred following discontinuation of Proscar;
- An entry for decreased libido after ceasing drug use; and
- An entry that described reports of male infertility and poor semen quality that normalized or improved after discontinuation of Proscar.
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.”
Despite these events no Proscar recall has been announced.
RLG’s Lawyers Will Make Things Easier
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 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 Proscar, submit this simple secure form for a free and confidential evaluation of your eligibility to file a Proscar lawsuit.