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Change to labels of 5-ARIs reflects increased risk of high-grade prostate cancer

Thursday, June 9, 2011 (Last Updated: 06/10/2011)

THURSDAY, June 9 (HealthDay News) -- Drugs in the class of 5-alpha reductase inhibitors (5-ARIs), which includes finasteride and dutasteride, have undergone a label change to reflect current safety information concerning an increased risk of high-grade prostate cancer, the U.S. Food and Drug Administration has announced.

Data influencing the label revision came from two large randomized controlled trials, which evaluated long-term daily use of the drugs for reducing the risk of prostate cancer. Patients taking either of the two drugs, which are used mainly to treat symptoms associated with an enlarged prostate, had lower incidence of lower-risk prostate cancer, but a higher risk for high-grade prostate cancer was also seen.

The FDA recommends that physicians evaluate patients to rule out conditions such as prostate cancer that may look like benign prostatic hyperplasia prior to starting a patient on 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the FDA.

More Information

Specialties Urology
Hematology & Oncology
Internal Medicine
Family Practice

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