The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours which may persist after treatment is stopped. Finasteride is also associated with sexual dysfunction.
The product information for finasteride and dutasteride containing medicines is being updated to provide more information on these side effects.
MHRA has recommended further measures to minimise this risk.
Advice for healthcare professionals
- finasteride is associated with depression, suicidal ideation and sexual dysfunction which may persist after treatment is stopped
- inform patients of the risks at point of prescribing and advise patients to read the finasteride patient cards and the patient leaflet for finasteride which are both supplied in the 1mg and 5mg packs
- the product information for finasteride 1mg will be updated with a warning that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has been reported without mood alterations
- when prescribing finasteride, review their medical record, ask patients if they have a history of depression or suicidal ideation and review patients regularly for psychiatric and/or sexual side effects
- patients prescribed finasteride 1mg should stop taking the medicine if they develop suicidal thoughts or depression and contact their healthcare professional as soon as possible
- patients prescribed finasteride 5mg or dutasteride should consult their healthcare professional as soon as possible if they develop suicidal thoughts or depression
- dutasteride works in a similar way to finasteride – therefore, as a precaution, a warning will be added to the dutasteride product information that mood alterations have been reported with the same class of medicine (finasteride)
- patients prescribed finasteride or dutasteride should contact their healthcare professional if they experience sexual dysfunction.
ScriptSwitch™ messages have been enabled to support prescribers.
