The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is going to evaluate data relating to suicidal ideation and behaviour.
The PRAC’S review concerns tablets/soft capsules containing 5 mg finasteride or 0.5 mg dutasteride, indicated for the treatment of benign prostatic hyperplasia (BPH), as well as tablets containing 1 mg finasteride and finasteride-based topical solutions, indicated for the treatment of the early stages of androgenetic alopecia.
During the review, the PRAC will assess all available data establishing a link between finasteride or dutasteride and suicidal ideation and behaviour. It will also evaluate the impact of suicidal ideation and behaviours on the benefit-risk balance of these medicinal products, taking into account the indications for which they are used.
In Belgium, only medicinal products indicated for the treatment of BPH are currently marketed, but magistral preparations are possible for the treatment of alopecia.
Medicinal products containing finasteride and dutasteride taken orally have a known risk of psychiatric side effects, including depression. Suicidal ideation has also recently been added as a possible adverse reaction, of unknown frequency, in the SPC and package leaflet of oral finasteride-containing medicinal products.
To minimise the risks, measures are already in place for finasteride-based medicinal products, for example:
• the SPC contains a warning for healthcare professionals to monitor patients for psychiatric symptoms and to stop treatment if symptoms appear;
• the package leaflet recommends patients to consult a doctor if they develop psychiatric symptoms.
The FAMHP recalls the importance of reporting any suspected adverse reaction in order to improve the safety profile of medicinal products including magistral preparations, and also in a context of off-label use.
Report adverse reactions via our website.
Specialities marketed in Belgium:
Finasteride 5 mg tablets: Proscar and generics
Dutasteride 0.5 mg soft capsules: Avodart and generics
Dutasteride 0.5 mg + tamsulosin 0.4 mg capsules modified release: Combodart and generics