New warnings will be added to the packaging of Finasteride after five men in Britain taking the drug developed breast cancer.
An analysis by the Medicines and Healthcare products Regulatory Agency found a total of 53 men worldwide on the drug had developed breast cancer.
The report from the MHRA said: "Cases of male breast cancer have been reported for finasteride, and the review suggested that an increased risk of male breast cancer associated with finasteride use cannot be excluded.
"Patients using finasteride products should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain or nipple discharge because these may be signs of a serious condition, such as breast cancer.
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