EMA Safety Panel Warns of Brian Tumor Risks with Cyproterone

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that patients only use medicines containing daily doses of 10mg or more of cyproterone for androgen-dependent conditions when other options have failed, citing a risk of non-cancerous brain tumors.

The androgen-dependent conditions include excessive hair growth, hair loss, acne and excessively oily skin. Following success with higher doses, the dose should be gradually reduced as low as possible while still remaining effective.

The committee advised that drugs containing cyproterone only be used for reduced sex drive in men when other treatments are deemed unsuitable, and recommended no change in their uses for prostate cancer.