Safety Alerts & Recalls

What does this mean?

The FDA believes that 5-ARIs remain safe and effective for their approved indications. Finasteride (Proscar), dutasteride (Avodart), and dutasteride/tamsulosin (Jayln) have been effective in controlling symptoms of benign prostatic hyperplasia (BPH), as well as in reducing the risks of acute urinary retention and the need for surgical intervention related to BPH.

If you are currently taking finasteride, dutasteride, or one of the brand names Proscar, Propecia, Avodart, Jalyn, you should follow up with your healthcare professional to review the risks and benefits of your medicine and decide the best treatment for your disease.

Please discuss any questions or concerns about 5-ARIs with your healthcare professional and do not stop taking your medication unless directed to do so by a healthcare professional. Healthcare professionals and patients are encouraged to report side effects related to the use of their medicines to the  FDA's MedWatch Safety Information and Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Issues Drug Safety Communication: Finasteride (Proscar, Propecia), Dutasteride (Avodart, Jalyn) May Increase the Risk of a More Serious Form of Prostate Cancer

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information that these drug products may increase the risk of high-grade prostate cancer. The product labeling will also state that 5-ARIs are not approved for the prevention of prostate cancer.

Medicines in the 5-ARI class are primarily used to treat the symptoms of benign prostatic hyperplasia (BPH) and include finasteride, marketed as Proscar and dutasteride, marketed as Avodart and marketed in combination with tamsulosin under the brand name Jalyn. Finasteride is also available under the brand name Propecia. The brand Propecia is only indicated for the treatment of male pattern hair loss in men.

The labels of all of these 5-alpha reductase inhibitors are being revised based on FDA's review of two large studies examining whether these medicines reduce the risk of prostate cancer. The studies did find an overall reduction in the risk of lower-grade forms of prostate cancer, but both studies also showed an increased risk of high-grade prostate cancer. High-grade prostate cancer is an aggressive type of prostate cancer, meaning it grows and spreads faster compared to low-grade prostate cancer. High-grade prostate cancer is a serious disease, but accounts for a small portion of all diagnosed prostate cancers. The applicability of the Avodart and Proscar studies to Propecia is currently unknown. While the dose of finasteride in Propecia is lower than the amount of finasteride in Proscar, the active ingredient is the same and the warnings are being added to the Propecia labeling out of caution. The FDA will continue its risk/benefit assessment of using 5-ARIs for the treatment for male pattern hair loss and will update the public when additional information is available.

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Source: FDA
Publication Date: 2011-06-09
Last Updated: 2011-06-09

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