Highlights from the September-October 2024 Medicines Safety Committee meeting

EZA starts a safety study on medicines containing finasteride and dutasteride

The review assesses data on suicidal ideation and behaviour

The National Medicines Agency states that the European Medicines Agency (EZA) has initiated a review of the safety of medicines containing finasteride and dutasteride due to concerns about suicidal thoughts and behaviour.

Tablets containing 1 mg of finasteride solution and topical finasteride are used to treat androgenic alopecia (hair loss caused by male hormones) in the early stages in men aged 18 to 41 years. Tablets containing 5 mg of finasteride and capsules containing 0.5 mg of dutasteride are used to treat benign prostatic hyperplasia (BPH) in men. BPH – an enlarged prostate gland that can cause urinary flow problems.

During the review, the EZA Pharmacovigilance Committee (PRAC) will evaluate all available data on suicidal ideation and behavior related to the use of finasteride and dutasteride. The PRAC also assesses the impact of these side effects on the benefit-risk balance of the medicine, taking into account the health conditions for which the medicine is being used.

Oral medicines containing finasteride and dutasteride have a known risk of psychiatric disorders (side effects), including depression. Recently Propecia and Proscar – the product description of the first two drugs containing finasteride, which were registered in several countries of the European Union (EU), included suicidal thoughts as a possible side effect exist, and it is not known how often they are.

Medicines containing finasteride already have measures in place to reduce the risk, including warnings in product information. They urge health care professionals to monitor patients for signs of psychiatric disorders and to stop treatment if such symptoms appear. Patients are advised to seek medical advice if they experience symptoms of a psychiatric disorder.

The EZA will evaluate all available data on suicidal ideation and behavior related to finasteride and dutasteride and will recommend whether the marketing authorizations for these medicines should be maintained, changed, discontinued or withdrawn across the EU.

Medicines containing finasteride and dutasteride are evaluated by the EZA Medicines Safety Committee (PRAC)*, in which medicine safety experts from the State Medicines Agency also participate.

New safety information for healthcare professionals: the associated risk of medication errors Plot and Levetiracetam UCB changing the oral solution dosing syringe

Plot and LevetiracetamUCB are medicines used to treat epilepsy alone or in addition to other anti-epileptic medicines.

The EZA Committee on the Safety of Medicines (PRAC) discussed the letter to healthcare professionals (HCPs) about the medicine Plot and Levetiracetam UCB Oral solution 100 mg/ml for use in children aged 6 months to 4 years (150 ml bottle), dosing syringe included in the package for volume adjustments. The 3 ml dosing syringe is replaced by a 5 ml dosing syringe. VVAS informs healthcare professionals about the potential risk of medication errors in relation to changes in the volume of the dosing syringe.

When prescribing and administering levetiracetam (Plot and Levetiracetam UCB) oral solution with the new 5 ml syringe, healthcare professionals should inform the patient’s caregivers about changes in the volume of the dosing syringe. Caregivers should be advised that although the new 5 ml syringe has 0.1 ml portions, it has an additional 0.25 ml portion compared to the 3 ml syringe. Caregivers should be instructed on the correct dose and how to measure it with a 5 ml syringe. Caregivers should be advised to read the instructions provided in the package leaflet on how to recognize the signs and symptoms of levetiracetam overdose and what to do in such a situation.

VVAS with Plot and Levetiracetam UCB It will be sent to the EZA Committee for Medicinal Products for Human Use (CHMP). Afterwards, the owner of the VVAS registration certificate will send to healthcare professionals, following the agreed communication plan. VVAS will be published on the website Direct healthcare professional communication (VVAS for healthcare professionals) and in the drug registers of the EU member states.

We invite you to see more information about what PRAC has done On the website of the European Medicines Agency – here (in English).

Experts from the State Agency of Medicines of Latvia also participate in the scientific committees of the European Medicines Agency, including the Medicines Safety Committee.

* PRAC – Pharmacovigilance Risk Assessment Committee EZA, or abbreviation – Medicines Safety Committee.

Source: ZVA