The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) convened remotely from May 5th to 8th, 2025, to address critical safety concerns and evaluate the risk-benefit profiles of several high-risk medicinal products. The meeting emphasized enhancing pharmacovigilance measures and implementing necessary risk mitigation strategies to ensure public health safety across the European Union.
Key Safety Procedures Initiated
During the session, PRAC reviewed urgent EU referral procedures, notably initiating a comprehensive assessment of the live attenuated Chikungunya vaccine, Ixchiq, following reports of serious adverse events in the elderly. Temporary measures restricting its use in individuals aged 65 and above were adopted to safeguard public health while a thorough investigation continues. Additionally, the committee scrutinized signals related to suicidal ideation in finasteride and dutasteride products, leading to mandatory updates in product information and enhanced patient communication strategies.
Major Product Evaluations
PRAC also evaluated new safety signals for medications such as sertraline and co-trimoxazole, resulting in updated warnings and risk management plans. The committee assessed periodic safety update reports (PSURs) for a range of products, reaffirming the favorable benefit-risk balance for most while recommending specific safety enhancements. Collaborative efforts with international regulators and ongoing scientific advice were highlighted as pivotal in maintaining robust pharmacovigilance frameworks.
– Rapid response to emerging safety concerns ensures timely protection of public health.
– Enhanced communication plans and patient information play a crucial role in mitigating risks.
– Continuous collaboration with global regulatory bodies strengthens overall safety surveillance.
EMA’s PRAC meeting underscored the agency’s commitment to proactive pharmacovigilance, demonstrating a vigilant approach in identifying and managing potential risks associated with medicinal products. The comprehensive evaluations and swift implementation of safety measures reflect PRAC’s dedication to maintaining high standards of drug safety and efficacy. Healthcare professionals and stakeholders are advised to stay informed about the latest updates to ensure the safe use of these medications.
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