The European Medicines Agency (EMA) has recommended the withdrawal of all medicines containing the active substance levamisole from the European Union (EU) market. The recommendation follows a detailed review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of levamisole medicines no longer outweigh their risks for treating parasitic worm infections.
Levamisole, historically used as an anti-parasitic agent, has been linked to serious neurological adverse effects, most notably leukoencephalopathy, a rare condition affecting the white matter of the brain. Cases have shown that symptoms can develop unpredictably, ranging from a single dose to several months after treatment. PRAC’s assessment found no effective risk-mitigation strategies or identifiable patient subgroups for whom the drug could be safely used. As a result, the committee recommended market withdrawal across the EU.
EMA has also stated that a Direct Healthcare Professional Communication (DHPC) will be issued to inform healthcare professionals about the safety concerns and to ensure the proper management of patients previously treated with levamisole-containing medicines. The DHPC will provide guidance on identifying potential adverse reactions and discontinuing use safely.
The withdrawal recommendation aligns with EMA’s commitment to pharmacovigilance and patient safety, reinforcing the importance of ongoing monitoring and risk assessment for medicines post-authorization. Regulatory authorities across EU member states will now take steps to implement the withdrawal, ensuring that levamisole medicines are no longer supplied or used in clinical practice.
Healthcare providers, patients, and distributors are advised to review their stock and treatment plans involving levamisole medicines and adhere to the EMA safety communication. For companies and distributors seeking support with regulatory compliance, pharmacovigilance, and supply chain management, professional services are available through Baupharma’s regulatory and distribution solutions to ensure alignment with EU requirements.
For more information: EMA recommends withdrawal of marketing authorisations for levamisole medicines
