Avodart (dutasteride) may increase risk of High-Grade Prostate Cancer, Male Breast Cancer.
Men taking Avodart (dutasteride) to treat an enlarged prostate face an increased risk and danger of developing high-grade prostate cancer, which grows and spreads faster than the more common form of the disease.
In June 2011, the U.S. Food & Drug Administration (FDA) mandated that the labels for Avodart and other drugs in the class known as 5-alpha reductase inhibitors, or 5-ARIs, include warnings about this serious prostate cancer risk. Additionally, in August 2011 officials in Canada announced that another 5-alpha reductase inhibitor (finasteride) be upgraded to include information regarding the an increased risk of male breast cancer.
According to Health Canada, 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.
High-Grade Prostate Cancer Signs & Symptoms
A PSA blood test is performed to screen for prostate cancer and it is due to PSA testing that most prostate cancers are found before they can cause any symptoms. These prostate cancer signs may also be caused by other prostate problems that arer not cancerous. The symptoms are:
- Delayed or slow start of urinary stream
- Dribbling or leakage of urine after urinating
- Slow urinary stream
- Straining when urinating
- Blood in the urine
- Bone pain or tenderness, often in lower back or pelvic bones ( occurs when the cancer has spread)
If you or a loved one were diagnosed with high-grade prostate cancer and have been recently diagnosed with male breast cancer while taking Avodart or any other 5-alpha reductase inhibitor class of drug, you may be entitled to compensation.
Parker Waichman LLP urges you to contact our Avodart lawyers today for a free lawsuit evaluation.
Avodart (dutasteride) 5-alpha reductase inhibitors, or 5-ARIs, Prostate and Male Breast Cancer
Avodart (dutasteride) FDA warnings were based on two studies indicating men who took Avodart and any of the other 5-ARI class of drugs were more likely to develop aggressive prostate tumors compared to men on a placebo. One of those trials, Reduction by Dutasteride of Prostate Cancer Events (REDUCE), compared dutasteride with placebo. The trial followed more than 8,000 men aged 50-79 for four years. Men on dutasteride had a 23% overall lower risk of being diagnosed with biopsy detectable prostate cancer when compared to men on placebo due to a reduction in low-risk tumors.
However, there was an increased incidence of high-grade prostate cancers with dutasteride versus placebo (1% versus 0.5%, respectively). GlaxoSmithKline, the maker of Avodart, had used the REDUCE trial in an attempt to persuade the FDA to expand the drug’s uses to include prostate cancer prevention, but the FDA rejected that request. Glaxo gave up the effort once the FDA mandated the new prostate cancer warning for Avodart and other 5-ARIs.