European regulators are recommending the withdrawal of all medications containing levamisolo, an active ingredient commonly used in antiparasitic drugs to treat worm infections. The move comes as concerns grow over a rare but serious neurological side effect linked to the drug.
Antiparasitic Drugs to be Pulled from Market Across the EU
The recommendation from the European Medicines Agency (EMA)’s safety committee, known as the Pharmacovigilance Risk Assessment Committee (Prac), follows a comprehensive safety review that determined “the benefits no longer outweigh the risks.”
Levamisolo has been associated with leucoencephalopathy, a severe neurological condition that damages the brain’s white matter. This condition, while rare, can have serious consequences for patients.
Which Medications are Affected?
The action specifically impacts:
- Anthelmintic medications (used to treat intestinal parasitic worms)
- Systemic antiparasitic medicines for mild infections
- Products containing levamisolo as a single active ingredient for human use
These medications are typically prescribed for non-life-threatening conditions, such as common parasitic infestations, for which safer alternative treatments are now available.
Unpredictable Risk and Limited Mitigation Strategies
According to the EMA, symptoms of leucoencephalopathy can appear even after a single dose of levamisolo and may manifest anywhere from one day to several months after treatment. The safety review did not identify any effective strategies to reduce the risk, specific patient groups that are more vulnerable, or a safe way to use the drug. This led to the negative benefit-risk assessment.
Market Withdrawal and Communication to Healthcare Professionals
Medications containing levamisolo will no longer be available in the European Union. The Prac has also approved a direct communication (Dhpc) to:
- Physicians
- Pharmacists
- Healthcare professionals
This communication aims to inform them directly about the risk of leucoencephalopathy and the decision to withdraw the drugs, with distribution through marketing authorization holders and publication in national health registries across EU countries. This action underscores the importance of ongoing drug safety monitoring and the need to balance treatment benefits with potential risks.
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