- Medicines and Healthcare products Regulatory Agency
- 24 May 2017
- Therapeutic area:
- Dermatology, Endocrinology, diabetology and metabolism, and Psychiatry
We have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss. Be aware that depression is also associated with finasteride 5 mg (Proscar).
Advice for healthcare professionals:
- since finasteride has been marketed there have been a number of spontaneous adverse drug reaction reports suggesting a possible link to depression, and in rare cases, suicidal thoughts
- advise patients to stop finasteride 1 mg (Propecia) immediately if they develop depression and inform a healthcare professional
- be aware that the product information for finasteride 5 mg (Proscar) already lists depression as a possible adverse reaction
Finasteride is a 5α-reductase-type-2 inhibitor. In the 1 mg dose (Propecia), it is indicated for the treatment of male pattern hair loss (androgenetic alopecia). In the 5 mg dose (Proscar), it is indicated for the treatment and control of benign prostatic hyperplasia.
Reports of major depression and suicidal thoughts
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.
Healthcare professionals are reminded that adverse reactions related to sexual function have been reported in association with finasteride. These include decreased libido, erectile dysfunction, and ejaculation disorders (such as decreased volume of ejaculate).
Reporting of suspected adverse reactions
Suspected adverse reactions should be reported to us via the Yellow Card Scheme.
Article citation: Drug Safety Update volume 10 issue 10, May 2017: 1.
Published: 24 May 2017