FDA Issues Warning about Potential Propecia Side Effects

Washington, DCThe US Food and Drug Administration (FDA) has issued a warning about potential Propecia side effects. Although Propecia side effects in men are generally thought to involve Propecia sexual dysfunction, the FDA warns that Propecia and similar drugs could be linked to prostate cancer.

On June 9, 2011, the FDA issued a warning about drugs in the 5-alpha reductase inhibitor (5-ARI) class, which includes Propecia and Proscar. Specifically, the FDA noted that the Warnings and Precautions section of the medications' labels would be updated to include information about the risk of being diagnosed with high-grade prostate cancer.

According to the FDA, the information was based on a review of two large, controlled trials: the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. The studies showed a reduction in the risk of low-grade prostate cancer, but an increased risk of high-grade prostate cancer.

Although rare, high-grade prostate cancer is an aggressive form of cancer that spreads more quickly than low-grade cancer.

5-ARIs are primarily prescribed to treat symptoms of benign prostatic hyperplasia (enlarged prostate). Proscar and Avodart have been approved to reduce the risk of urinary retention. Propecia is prescribed to treat hair loss in men. Propecia was not included in either of the trials (Proscar and Avodart were the medications studied), but because Propecia contains 1 mg of finasteride, the active ingredient in Proscar, Propecia is included in the updated warnings.

Despite the updated warnings, FDA says it believes drugs in the 5-ARI class are safe for their approved uses. A risk/benefit assessment of the medications is ongoing. The FDA recommends that patients be evaluated prior to beginning treatment with 5-ARI medications to ensure the patient does not have other urological conditions that mimic benign prostatic hyperplasia. Furthermore, FDA advises physicians and patients that 5-ARI medications are not approved to prevent prostate cancer.

According to the FDA, approximately 5 million men were prescribed a 5-ARI medication from 2002 to 2009, with nearly 3 million of those men between the ages of 50 and 79.