Dutasteride DHPC
For Healthcare Professionals
Summary of the safety concern:
•
Suicidal ideation is an adverse reaction of oral finasteride-containing products, mainly reported in patients treated for androgenetic alopecia.
•
Advise patients treated with oral finasteride for androgenetic alopecia to stop treatment and seek medical advice if they experience depressed mood, depression or suicidal ideation.
•
Sexual dysfunction that may contribute to mood alterations, including suicidal ideation, has been reported in some patients treated for androgenetic alopecia. Sexual dysfunction may also occur without mood alterations. Inform patients to seek medical advice in case of experiencing sexual dysfunction and consider discontinuation of treatment.
•
A Patient Alert Card is available in the package of medicinal products containing finasteride to highlight the risks of depressed mood, depression, suicidal ideation and sexual dysfunction reported with finasteride.
•
Despite the insufficient evidence to establish a direct association of suicidal ideation with dutasteride, based on the common mechanism of action for medicinal products of the class of 5-alpha reductase inhibitors, patients treated with dutasteride should be recommended to seek prompt medical advice if symptoms of mood alterations occur.
