Regulatory Update: MHRA Issues Drug-Safety Update on Finasteride

May 26, 2017

Dear Friends:

The UK’s equivalent of the US Food and Drug Administration, the Medicines and Healthcare Products Regulatory Agency (MHRA), has issued a drug safety update on finasteride.

The May 24 document, titled Finasteride: rare reports of depression and suicidal thoughts, states:

Some men have reported episodes of depressive illness in association with the use of Propecia for male pattern hair loss. Some men also reported having suicidal thoughts.

Depression and suicidal thoughts have been reported in men with and without a previous history of depression. Depressed mood has been previously recognised with Propecia. A recent review of the evidence has suggested more significant depression can occur and so the advice is being updated to reflect this.

The product information for Proscar already lists depression as a possible adverse reaction and is being updated in light of a recent review.

The update also recommends that health care professionals “advise patients to stop finasteride 1 mg (Propecia) immediately if they develop depression.”

This action, and forthcoming label change, would not have occurred if the family members of several PFS patients who took their own lives had not brought those cases to the attention of the MHRA—and demanded that something be done.

For that, we thank them. And we encourage families of other PFS patients in nations across the globe to speak out with equal determination.

If you or a loved one suffer from persistent finasteride side effects, please report those side effects to the appropriate agency:

Thank you.