Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) - 9-12 February 2026:

EMA’s safety committee, the PRAC, has recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide safety review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections due to the risk of leukoencephalopathy, a rare but serious side effect of levamisole that affects the brain’s white matter.

Overall, considering that levamisole medicines are used to treat mild parasitic worm infections, and that levamisole-induced leukoencephalopathy is a serious condition with an unpredictable onset, the benefit–risk balance of these medicines was considered negative.