Jalyn may increase Prostate Cancer and Male Breast Cancer. Jalyn, a drug used to treat enlarged prostate, may be associated with an increased risk of high-grade prostate cancer, an especially aggressive form of the disease. Jalyn contains a combination of dutasteride and tamsulosin, dutasteride is a type of drug known as a 5-alpha reductase inhibitors, or 5-ARIs.
In June 2011, the U.S. Food & Drug Administration (FDA) ordered the makers of 5-ARIs, including Jalyn, to add information about the high-grade prostate cancer risk to the “Warnings and Precautions” sections of the drugs’ labels. In August 2011, regulators in Canada announced that the labels of another 5-alpha reductase inhibitor product (finasteride) sold there would be updated to include information regarding their possible association with 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.
If you or a loved one were diagnosed with high-grade prostate cancer and have been recently diagnosed with male breast cancer while taking jalyn or any other 5-alpha reductase inhibitor class of drug, you may be entitled to compensation.
Parker Waichman LLP urges you to contact our Jalyn lawyers today for a free lawsuit evaluation.
Jalyn (dutasteride/tamsulosin) 5-alpha reductase inhibitors (5-ARIs), Prostate and Male Breast
Jalyn (dutasteride/tamsulosin) FDA warning was based on two studies indicating men who took Jalyn 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, and followed more than 8,000 men aged 50-79 for four years. While 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.
By contrast, there was an increased incidence of high-grade prostate cancer with dutasteride versus placebo (1% versus 0.5%, respectively). The maker of ‘Jalyn’, GlaxoSmithKline, hade used the REDUCE trial in an attempt to persuade the FDA to expand the drug’s use too include prostate cancer prevention
The FDA rejected the request and mandated the new prostate cancer warning for Jalyn and other 5-ARIs.