During its October 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started safety review of medicines containing finasteride and dutasteride, to assess data related to suicidal thoughts and behaviours. Furthermore the PRAC formulated new safety information intended to healthcare professionals (DHPC) regarding a risk of medication errors due to change of dosing syringe for Keppra oral solution 150ml 100mg (levetiracetam)/1ml (with dosing syringe of 3 ml).
Finasteride and Dutasteride
The European Medicines Agency (EMA) started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.
Tablets containing 1 mg of finasteride and finasteride solution for application to the skin are used to treat the early stages of androgenic alopecia (hair loss due to male hormones) in men aged 18 to 41 years. Tablets containing 5 mg finasteride and capsules containing 0.5 mg dutasteride are used to treat men with benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged and can cause problems with the flow of urine.
During the review, the Pharmacovigilance Risk Assessment Committee (PRAC) will assess all available data linking finasteride and dutasteride to suicidal ideation and behaviours. It 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.
Medicines containing finasteride and dutasteride taken by mouth have a known risk of psychiatric side effects, including depression. Suicidal ideation has also recently been added as a possible side effect of unknown frequency in the product information for Propecia and Proscar, the first two finasteride-containing medicines authorised in several countries of the European Union (EU). To minimise the risks, measures are already in place for finasteride medicines, including warnings in the product information for healthcare professionals to monitor patients for psychiatric symptoms and stop treatment if symptoms occur, and recommendations for patients to seek medical advice if they experience psychiatric symptoms.
EMA will now review all available data on suicidal ideation and behaviours with finasteride and dutasteride and issue a recommendation on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the EU.
In Belgium, medicines containing finasteride or dutasteride, either alone or in combination with tamsulosin, are authorised and marketed under the following names:
- medicines with finasteride as the active ingredient: Finasteride Viatris, Finasteride Teva, Finasteride EG, Proscar;
- medicines with dutasteride as the active ingredient: Avodart, Dutasteride AB, Dutasteride Krka, Dutasteride Sandoz;
- medicines with dutasteride and tamsulosin as active ingredients: Combodart, Dutasteride/Tamsulosin EG, Dutasteride/Tamsulosin HCL AB, Dutasteride/Tamsulosin Sandoz, Dutasteride/Tamsulosin Teva, Dutasteride/Tamsulosin Viatris.
Keppra oral solution 150 ml 100 mg (levetiracetam)/1 ml (+ dosing syringe of 3 ml)
Keppra is a medicine used to treat epilepsy, on its own or as an add-on to another anti-epileptic medicine.
The PRAC discussed a direct healthcare professional communication (DHPC) regarding a change to the dosing syringe included in the product packaging of Keppra 100 mg/ml oral solution intended for use in children aged 6 months to 4 years (150 ml bottle). The 3 ml dosing syringe is being replaced with a 5 ml dosing syringe. The DHPC will inform healthcare professionals of the potential risk of medication errors due to the change in the volume of the dosing syringe.
When prescribing and dispensing Keppra oral solution with the new 5 ml syringe, healthcare professionals should inform caregivers about the change in the volume of the dosing syringe. Caregivers should be informed that while the new 5 ml syringe is graduated every 0.1 ml, it has additional graduations of 0.25 ml compared to the 3 ml syringe. Caregivers should be counselled on the correct dose and how to measure it with the 5 ml syringe. Caregivers should be advised to read the instructions in the package information leaflet on how to recognise signs and symptoms of a levetiracetam overdose and what to do in this situation.
The DHPC for Keppra will be forwarded to EMA’s human medicines committee (CHMP). When adopted, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.
Keppra oral solution in a 150 ml bottle, containing 100 mg of levetiracetam per ml, with a 3 ml dosing syringe, is authorised and marketed in Belgium.
More information is available on the EMA website.