Finasteride Male Breast Cancer Risk. Finasteride (Propecia, Proscar) Use increases risk of High-Grade Prostate Cancer and Male Breast Cancer Risk.
In June 2011, the U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication warning that men taking Finasteride may face a higher risk of developing high-grade prostate cancer. At the time, the FDA mandated that the labels for ‘Finasteride’ medications be updated to warn of this risk. Additionally, in August 2011, the Canadian Health Agency, Health Canada, stated that male breast cancer has been reported in a small number of patients worldwide with both the 1 mg and 5 mg formulations of finasteride, though most have been associated with the 5mg formulation. Health Canada has advised that men taking finasteride contact their doctors should they experience breast enlargement, breast lumps, pain or tenderness, nipple discharge, or any other changes while taking the drug.
If you or a loved one were diagnosed with high-grade prostate cancer or have been recently diagnosed with male breast cancer while taking Proscar, Propecia or other 5-ARI class of drugs, you may be entitled to compensation. The defective drug lawyers at Parker Waichman LLP are experienced in defective drug litigation and are offering free lawsuit evaluations to 5-ARI victims and their families. To learn how our 5-ARI (5-alpha reductase inhibitor) lawyers can help you, we urge you to contact us today.
Finasteride and High-Grade Prostate Cancer, Male Breast Cancer Risks
Finasteride is sold under the brand names Proscar (Finasteride 5mg), Propecia (Finasteride 1mg), and as a generic medication. The 5mg version of ‘Finasteride’ is used to treat enlarged prostate, while the 1mg dose treats male pattern baldness. ‘Finasteride’ belongs to a class of drugs called 5-Alpha Reductase Inhibitors, or 5-ARIs.
Ironically, the association between 5-ARIs like Finasteride and high-grade prostate cancer was discovered during two clinical trials (one involving Finasteride and the other involving dustasteride) focused on determining whether the drugs could prevent prostate cancer. While a reduction in a less serious form of prostate cancer was seen in these studies, an increase in the number of high-grade tumors was also observed.
The Prostate Cancer Prevention Trial, or PCPT, involved nearly 19,000 men age 55 years or older who took either ‘Finasteride’ or a placebo. The men were followed for up to seven years. Of those who took Finasteride 5mg for seven years, 1.8% were found to have high-grade prostate cancer, according to FDA. By contrast, only about 1.1% of the men who took a placebo were diagnosed with high-grade prostate cancer.
In its Drug Safety Communication, the FDA said it would modify the “Warnings and Precautions” sections of the labels of all FDA-approved 5-ARIs, including ‘Finasteride’, to include new information that they may increase the risk of high-grade prostate cancer. The new product labeling also states that ‘Finasteride’ and other 5-ARIs are not approved for the prevention of prostate cancer.