Dutasteride use may increase High-Grade Prostate Cancer and Male Breast Cancer Risk Dutasteride, sold under the brand names Avodart and Jalyn, and used to treat an enlarged prostate has been associated with an increased risk of developing high-grade prostate cancer. High-grade prostate cancer is an aggressive form of the disease, growing and spreading faster than the more common form of the disease.
In June 2011, the U.S. Food & Drug Administration (FDA) mandated that warnings regarding high-grade prostate cancer be added to the labels of dutasteride and other 5-alpha reductase inhibitors (5-ARIs) class of drugs. Additionally, in August 2011, officials in Canada announced that another 5-alpha reductase inhibitor (finasteride) be upgraded to include information regarding an increased risk of male breast cancer.
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 (a firm, nonpainful mass just below the nipple). Other symptoms men should take note of that may occur include:
- Ulceration of the skin around the nipple
- Puckering, Dimpling, Redness or Scaling of the nipple
- Retraction (turning inward) of the nipple
- Bloody or opaque discharge from the nipple
Male breast cancer that has spread (metastasized) to the bones may also produce bone pain at the metastasized sites. The average size of breast cancer in men when first discovered is approximately 2.5cm and less than 1% of cases are bilateral or occurring in both nipples.
Lawyers at Parker Waichman LLP specializing in defective drug litigation are offering free lawsuit evaluations to dutasteride prostate cancer victims and their families. If you took dutasteride, Avodart or Jayln and were diagnosed with a serious form of prostate cancer, you may be eligible for compensation. To make sure your legal rights are protected, we urge you to contact one of our dutasteride lawyers today for your free case evaluation.
Dutasteride and High-Grade Prostate Cancer
Dutasteride, Avodart and Jalyn (dutasteride and tamsulosin) are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). They belong to a class of drugs known as 5-alpha reductase inhibitors, or 5-ARIs. Other drugs in this class include the prostate medication Proscar (finasteride 5 mg), and Propecia (finasteride 1 mg), which is used to treat male pattern baldness.
In a Drug Safety Communication issued on June 9, 2011, the FDA announced that the “Warnings and Precautions” sections of the labels for all 5-ARIs, including dutasteride, Avodart and Jalyn, would be modified to reflect a possible increased risk of high-grade prostate cancer. The agency said the decision to modify the labels of 5-ARIs was based on its review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial.
The REDUCE study involved 8,231 men, aged 50 to 75, who received either placebo or dutasteride 0.5 mg once daily for a total of four years. The results of the REDUCE trial showed that men on dutasteride had a 23 percent overall lower risk of being diagnosed with biopsy detectable prostate cancer when compared to men on placebo. However, this overall risk reduction was limited to a decrease in less serious cancers (Gleason Scores of 6 or lower). In contrast, there was an increased incidence of high-grade cancers (Gleason Scores of 8-10) with dutasteride versus placebo.
High-grade prostate cancer is an aggressive type of prostate cancer, meaning it grows and spreads faster compared to low-grade prostate cancer. According to the FDA, high-grade prostate cancer is a serious disease, but accounts for a small portion of all diagnosed prostate cancers.Dutasteride High-Grade Prostate Cancer and Male Breast Cancer Victims – Legal Help