In the wake of what is quickly becoming a major concern in the pharmaceutical community, Health Canada is informing healthcare practitioners and patients of specific labeling updates regarding finasteride. Finasteride, the active ingredient in both Propecia and Proscar, has recently received intense scrutiny regarding its association with catastrophic side effects including male breast cancer. As a result, Merck & Co. has issued a product labeling change for their finasteride medications.
In an attempt to develop a medication intended to treat an enlarged prostate, Merck & Co. developed Proscar, an oral tablet that contained 5 mg of finasteride. However, a reformulation witnessed Proscar evolve into what is now known as Propecia. Propecia (1 mg tablets) are used in the treatment of male pattern baldness, while Proscar (5 mg tablets) are used in the treatment and prevention of benign prostatic hyperplasia (BPH), otherwise known as an enlarged prostate.
Finasteride, the active ingredient in both Proscar and Propecia, belongs to unique group of medications known as 5α-reductase inhibitors. As a 5α-reductase inhibitor finasteride metabolizes testosterone into the more potent androgen dihydrotestosterone (DHT). In doing so, these actions assist in the treatment of an enlarged prostate or even help re-grow hair on the scalp.
Despite the ability to re-grow hair, catastrophic finasteride side effects greatly outweigh the potential benefits. The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a report on the possible association between the use of finasteride and breast cancer in males. As of November 2009, fifty cases of breast cancer had been reported worldwide with 5 mg finasteride and three cases with the 1 mg dose.
A potential mechanism for the association between these medications and male breast cancer may be directly related to the pharmacodynamics of finasteride. The introduction of finasteride into the bloodstream leads to a significantly increased amount of DHT levels that are accompanied by a decreased level of testosterone and oestradiol. The decrease in these sex steroids may lead to an increase in the risk of male breast cancer.
The term breast cancer refers to a malignant tumor that has developed in breast tissue. Often times, this tumor is characterized by a lump or hard mass protruding out of the breast tissue. In the event that male breast cancer begins to metastasize, the uncontrolled growth of the tumor can prove to be fatal.
The labelling for Propecia, Proscar and several of the generic finasteride products has already been updated to include information on the potential risk of male breast cancer. Updates to the remaining generic drugs will follow.
Do I Have a Finasteride Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in finasteride lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by finasteride, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.