Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025
Review of medicines containing finasteride and dutasteride concluded
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Review of medicines containing finasteride and dutasteride concluded
Finasteride and dutasteride tablets: Measures to minimise risk of suicidal thoughts
Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.
A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the product information for finasteride medicines. Patients who experience mood changes should seek medical advice and, if taking finasteride 1 mg, should also stop treatment.
Most cases of suicidal ideation were reported in people using 1 mg finasteride to treat hair loss due to male hormones. The product information for finasteride 1 mg will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction) that have been reported to contribute to mood alterations and suicidal ideation in some patients. A patient card will be included in the 1 mg finasteride package to remind patients of these risks and to advise them about the appropriate course of action.
Although a link between suicidal ideation and dutasteride was not established based on the reviewed data, dutasteride works in the same way as finasteride. Therefore, information about the mood changes seen with finasteride will also be added to dutasteride’s product information as a precaution.
The review found no evidence linking suicidal ideation to finasteride skin sprays and no new information is being included in the product information for these sprays.
Finasteride 1 mg tablets and finasteride skin spray are used to treat early hair loss due to male hormones, while finasteride 5 mg tablets and dutasteride 0.5 mg capsules are used to treat benign prostatic hyperplasia, a condition in which the prostate is enlarged and can cause problems with urine flow.
More information is available in EMA’s public health communication.
Start of safety review of Ixchiq (live attenuated chikungunya vaccine)
EMA’s safety committee (PRAC) has started a review of Ixchiq, a live attenuated chikungunya vaccine, following reports of serious adverse events in elderly people.
Many of the people affected also had other illnesses and the exact cause of these adverse events and their relationship with the vaccine have not yet been determined.
So far, 17 serious adverse events have been reported worldwide in people aged between 62 to 89 years who received the vaccine.
Given that clinical studies on Ixchiq mainly involved people below 65 years of age and that most serious cases concerned people 65 years of age and above, PRAC recommends that Ixchiq must not be used in adults aged 65 years and above as a temporary measure while the review is underway. Ixchiq vaccination can continue in people under 65 years of age, in accordance with official recommendations.
PRAC also reminds healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatments. Persons with a weakened immune system are at greater risk of having complications from vaccines containing live attenuated viruses, regardless of age.
Ixchiq is a vaccine used to protect people in endemic areas and travellers to endemic areas against a mosquito-borne disease caused by the chikungunya virus, mostly present in tropical and subtropical regions. Symptoms include fever, painful joints, headache, muscle pain, joint swelling and rash. Most patients recover within a week, but some develop joint pain for several months or longer and a small proportion of patients may develop severe acute disease, which can lead to multiorgan failure.
Ixchiq was authorised as a single-dose vaccine for chikungunya on 28 June 2024. Around 43,400 doses are estimated to have been used worldwide.
PRAC will now review all available data to assess the benefits and risks of the vaccine. EMA will communicate further when appropriate.
More information is available in EMA’s public health communication, published on 7 May 2025.
Agenda
PRAC statistics: May 2025
Glossary
- Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under 'Signal management'.
- Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under 'Periodic safety update reports: questions and answers'.
- Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans'.
- Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under 'Post-authorisation safety studies'.
- Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.