The drug labeling for 5-alpha-reductase inhibitors (5-ARIs), a class of medications that includes finasteride and dutasteride, must now include a warning that the drugs may increase the risk for high-grade prostate cancer (PCa), according to the FDA.

Finasteride and dutasteride are FDA approved for treating benign prostatic hyperplasia (BPH).

The new safety information is based on the agency’s review of two large, randomized controlled trial: the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCT) trial. In both studies, use of the medications was associated with an approximately 25% decreased risk of prostate cancer overall compared placebo. However, data suggested high-grade tumors were more likely to develop in men who took either medication.

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The FDA recommends that, prior to initiating therapy with 5-ARIs, clinicians perform evaluations to rule out other urological conditions, including PCa, that might mimic BPH.