The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has commenced a review of medicines containing levamisole, focusing on the potential risk of leukoencephalopathy, a serious neurological condition. This decision was made during the PRAC meeting held from September 1 to 4, 2025, highlighting the committee’s ongoing commitment to patient safety and drug efficacy.
This review comes in the wake of emerging safety signals that suggest a potential causal association between levamisole and leukoencephalopathy. As levamisole is utilized in various therapeutic contexts, including as an anti-parasitic agent, the implications of this review could be significant for regulatory compliance and market access for affected products. Stakeholders in regulatory affairs, quality assurance, and supply chain management should closely monitor the outcomes of this assessment, as it may necessitate changes in labeling, usage recommendations, or even market withdrawal for certain formulations.
