Agenzia Italiana del Farmaco
EMA starts safety review of medicines containing finasteride and dutasteride - EMA starts safety review of medicines containing finasteride and dutasteride
EMA starts safety review of medicines containing finasteride and dutasteride
EMA started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.
During the review, PRAC will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours.
t will also evaluate the impact of suicidal ideation and behaviours on the benefit-risk balance of these medicines, taking into consideration the conditions they are used to treat
Published on: 04 October 2024