The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has unveiled a series of critical recommendations targeting safety signals identified in various medicinal products. These measures, adopted during the May 5-8, 2025 meeting, aim to enhance patient safety across both centrally and nationally authorized medications within the EU.
Key Recommendations for Product Information Updates
PRAC has mandated that Marketing Authorization Holders (MAHs) of specific drugs, including sertraline and co-trimoxazole, must revise their product information within two months. For instance, sertraline’s adverse effects section will now include multiple acyl-coenzyme A dehydrogenase deficiency (MADD)-like disorders, while co-trimoxazole labels will warn of potential circulatory shock, especially in immunocompromised patients.
Supplementary Information and Regulatory Actions
In addition to label updates, PRAC requested supplementary information from MAHs of other medications such as Adalimumab and Dabigatran by specified deadlines. These actions reflect PRAC’s commitment to thorough post-marketing surveillance and proactive risk management. MAHs must adhere to both EU-wide and national procedures to implement these changes effectively.
• Enhanced monitoring of sertraline and co-trimoxazole for MADD-like disorders and circulatory shock
• Strict deadlines for MAHs to submit updated product information
• Increased scrutiny on medications like Adalimumab and Osimertinib through supplementary data requests
• Coordinated efforts between PRAC, CHMP, and NCAs to ensure compliance
• Emphasis on timely updates to keep product information aligned with the latest safety findings
The PRAC’s proactive stance underscores the EU’s dedication to safeguarding public health by promptly addressing newly identified drug risks. By enforcing these recommendations, the agency ensures that both healthcare providers and patients are well-informed about potential adverse effects.
Effective communication between PRAC and MAHs, along with adherence to established regulatory frameworks, plays a pivotal role in the successful implementation of these safety measures. The collaborative approach aims to minimize risks and enhance the overall efficacy of medicinal products available within the European market.
Healthcare professionals should stay updated with the latest PRAC recommendations to ensure they are providing the safest treatment options to their patients. Patients, in turn, are encouraged to consult with their healthcare providers regarding any concerns related to their medications.
These comprehensive actions by PRAC not only address immediate safety concerns but also reinforce the EU’s robust pharmacovigilance system. Continuous monitoring and timely updates are essential in maintaining the trust and well-being of the public regarding pharmaceutical treatments.
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