Overview
- EMA’s Pharmacovigilance Risk Assessment Committee concluded after an EU safety review that the benefit–risk profile of levamisole medicines is negative.
- The committee reported cases of leukoencephalopathy occurring after a single exposure with symptom onset ranging from one day to several months.
- Most affected products are levamisole monotherapies used as anthelmintics for mild parasitic infections where safer alternatives are available.
- A Direct Healthcare Professional Communication was approved for distribution by marketing authorization holders and publication in national health registries.
- National authorities are implementing market withdrawal, which will make levamisole-containing medicines unavailable across the European Union.