MHRA Strengthens Safety Warnings for Finasteride and Dutasteride
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated safety advice to strengthen warnings regarding potential psychiatric and sexual dysfunction associated with finasteride. Additionally, precautionary advice has been introduced for dutasteride, a similar medication. This action follows a detailed review of evidence, including outcomes from a European regulatory review. The updates aim to provide clearer guidance for healthcare professionals and patients, emphasizing that sexual dysfunction may contribute to mood disorders. For finasteride 1mg, used for male pattern hair loss, warnings now clarify the link between sexual side effects and mood alterations. For dutasteride, used for benign prostatic hyperplasia, a precautionary warning notes reported mood alterations in its drug class. Existing patient alert cards highlighting risks of depression and suicidal thoughts remain in effect. Dr. Alison Cave, MHRA Chief Safety Officer, stressed the importance of informed discussions between prescribers and patients. Patients experiencing depression or suicidal thoughts are advised to stop treatment and seek medical help. The MHRA continues to encourage reporting suspected adverse reactions through the Yellow Card scheme to ensure ongoing patient safety and monitoring.
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MHRA Strengthens Safety Warnings for Finasteride and Dutasteride
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated safety advice to strengthen warnings regarding potential psychiatric and sexual dysfunction associated with finasteride. Additionally, precautionary advice has been introduced for dutasteride, a similar medication. This action follows a detailed review of evidence, including outcomes from a European regulatory review. The updates aim to provide clearer guidance for healthcare professionals and patients, emphasizing that sexual dysfunction may contribute to mood disorders. For finasteride 1mg, used for male pattern hair loss, warnings now clarify the link between sexual side effects and mood alterations. For dutasteride, used for benign prostatic hyperplasia, a precautionary warning notes reported mood alterations in its drug class. Existing patient alert cards highlighting risks of depression and suicidal thoughts remain in effect. Dr. Alison Cave, MHRA Chief Safety Officer, stressed the importance of informed discussions between prescribers and patients. Patients experiencing depression or suicidal thoughts are advised to stop treatment and seek medical help. The MHRA continues to encourage reporting suspected adverse reactions through the Yellow Card scheme to ensure ongoing patient safety and monitoring.
Medicines and Healthcare products Regulatory Agency - Activity on GOV.UK