EMA Recommends Withdrawal of Levamisole Medicines Across the EU Due to Serious Neurological Risk
The European Medicines Agency (EMA) has recommended the withdrawal of marketing authorisations for all medicines containing levamisole, an active ingredient primarily used in treatments for parasitic worm infections. This decision, made by the Pharmacovigilance Risk Assessment Committee (PRAC), follows an EU-wide safety review and concludes that the benefits of levamisole no longer outweigh the risks to patients.
Leukoencephalopathy: A Serious and Rare Side Effect
The EMA’s safety review identified leukoencephalopathy as a serious neurological side effect linked to levamisole. Leukoencephalopathy is a rare but severe disease that affects the white matter of the brain. Symptoms can appear even after a single dose of levamisole and may manifest from one day to several months after treatment [EMA].
Which Medicines are Affected?
The withdrawal applies to the following types of medicines:
- Anthelmintics (medicines against intestinal parasitic worms)
- Systemic antiparasitic medicines used for mild infections
- Products containing levamisole as monotherapy for human use
These medicines are typically prescribed for non-serious conditions, such as common parasitic infestations, for which safer alternatives are now available [EMA].
Unpredictable Risk and Lack of Mitigation Strategies
The EMA review found that there are no effective strategies to reduce the risk of leukoencephalopathy, and no specific patient groups were identified as being more exposed. A safe use of the active ingredient could not be defined. Due to this unpredictable risk and the lack of mitigation strategies, the benefit-risk ratio was deemed negative [EMA].
Market Withdrawal and Communication to Healthcare Professionals
Medicines containing levamisole will no longer be available in the European Union. The PRAC has also issued an official communication (DHPC) to inform doctors, pharmacists, and other healthcare workers about the risk of leukoencephalopathy and the decision to withdraw these medicines. This information will be disseminated through marketing authorization holders and published in the national health registers of EU countries [EMA].
About the PRAC
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines within the European Medicines Agency (EMA). The committee meets monthly and publishes agendas, minutes, and highlights of its plenary meetings [EMA].