Proscar, Propecia Breast Cancer Reports Prompt Label Change in Canada

Health Canada announced yesterday that the manufacturers of finasteride products, including Propecia, <"">Proscar and their generic equivalents, are updating the drugs’ labels to add safety information on rare reports of breast cancer in men. Patients taking Proscar, <"">Propecia or another finasteride product should report any changes in their breasts, including breast enlargement, lumps, tenderness, pain or nipple discharge, to their doctor, Health Canada said.

Proscar and 5 mg finasteride drugs are used in the treatment and control of non-cancerous enlarged prostate. Propecia and 1 mg finasteride is used to treat male pattern baldness.

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. Based on the currently available evidence, it is not known with certainty whether finasteride can cause breast cancer, nor can this possibility be ruled out at this point in time, Health Canada said.

The Canadian of label for Propecia, Proscar and several 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, Health Canada said.

In June, the U.S. Food & Drug Administration (FDA) announced that the “Warnings and Precautions” sections in the labels of finasteride products, including Propecia and Proscar, would be changed to reflect a possible association with high-grade prostate cancer. The FDA label change applied to all drugs sold in the U.S. that are known as <"">5-alpha reductase inhibitors, or 5-ARIs, including Avodart (dutasteride) and Jalyn (dutasteride and tamsulosin).

The FDA announced the labeling change after two large studies showed that while 5-ARIs reduced the overall risk of prostate cancer, they increased the risk that a user would develop a more serious type of tumor known as high-grade prostate cancer. This type of tumor grows and spreads faster compared to low-grade prostate cancer.

According to the FDA, almost 5 million men were prescribed a 5-ARI medication between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.

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