Review assesses data related to suicidal thoughts and behaviours
EMA has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.
Tablets containing 1 mg 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.
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, stop treatment if symptoms occur, and recommendations for patients to seek medical advice if they experience psychiatric symptoms.
More information is available in EMA’s public health communication.
Keppra and Levetiracetam UCB are medicines used to treat epilepsy, on their 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 and Levetiracetam UCB 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 levetiracetam (Keppra and Levetiracetam UCB) 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 and Levetiracetam UCB will be forwarded to EMA’s human medicines committee (CHMP). When adopted, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holders, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.
