At its May 2025 meeting, the European Medicines Agency Risk Assessment Committee proposed new risk mitigation measures for finasteride and dutasteride. Suicidal thoughts were confirmed as an adverse effect for finasteride, but not for dutasteride. Belgium does not agree with the conclusion. The PRAC also initiated a review of Ixchiq (live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.
New risk mitigation measures for finasteride and dutasteride approved
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has completed the safety assessment of medicinal products containing finasteride and dutasteride. Suicidal thoughts were confirmed as an adverse effect of finasteride tablets; no direct association was found for dutasteride. New risk mitigation measures were proposed. Belgium expressed its disagreement with the conclusion of the procedure, believing that the measures proposed for the oral formulation of finasteride 1 mg are not sufficient to offset the risks. Finasteride 1 mg is currently not authorised in Belgium.
Based on the reported cases and the available relevant literature, the PRAC concluded that a causal relationship between oral finasteride 1 mg and suicidal thoughts has been confirmed and that a positive benefit-risk ratio in the indication androgenic alopecia remains positive when appropriate risk mitigation measures are implemented.
However, analysis of the data clearly revealed new aspects of the risks associated with psychiatric disorders and sexual dysfunction. These risks significantly alter the safety profile of oral finasteride 1 mg for the approved indication for androgenic alopecia, a benign, lifelong condition. The expected benefits of stabilising hair loss in this benign condition do not outweigh the severity of these risks, with potentially fatal consequences, in the target population of young, healthy patients. The recommended risk mitigation measures, including updates to product information, patient chart and communication with a Direct Healthcare Professional Communication (DHPC), will not adequately prevent the newly identified significant risk of suicidal thoughts.
Consequently, Belgium considers that the benefit-risk ratio of finasteride 1 mg in androgenic alopecia is negative. The oral form of finasteride 1 mg is not authorised in Belgium. Belgium made this opinion officially known to the PRAC through a divergent opinion that will be published on the EMA website at the end of the procedure.
More information is available on the EMA website.
Review of the Ixchiq vaccine
Following reports of serious adverse events in elderly people, the PRAC initiated a review of the Ixchiq vaccine, a live attenuated chikungunya-vaccine. 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 cases have been reported in people from 62 to 89 years of age, two of which resulted in death. Given that studies on Ixchiq mainly involved people below 65 years of age and the vast majority of the serious cases concerned persons 65 years of age and above, the Committee is temporarily recommending restricting the use of the vaccine. While an in-depth review is ongoing, Ixchiq will be contraindicated in adults aged 65 years and above. Vaccination with Ixchiq can be continued in people younger than 65 years of age according to official recommendations.
In addition to the new restriction, the Committee is also reminding healthcare professionals that Ixchiq must not be given to people whose immune system is weakened due to disease or medical therapy. Persons with a weakened immune system are at greater risk of having complications from vaccines containing live attenuated viruses, regardless of age.
The PRAC will now review all available data to assess the benefits and risks of the vaccine and make a recommendation on whether to change the terms of its marketing authorisation.
Chikungunya is a mosquito-borne disease caused by the chikungunya virus. It is 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 have been used worldwide. The Ixchiq vaccine is available in Belgium.
More information is available on the EMA website.