EMA recommends withdrawal of marketing authorisations for levamisole medicines – www.ema.europa.eu

13 Feb, 2026

www.ema.europa.eu

EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections in adults and children.

The review confirmed that leukoencephalopathy is a rare but serious side effect of levamisole. Leukoencephalopathy damages the white matter of the brain, which is made of nerve fibres covered by myelin, a protective layer that allows efficient communication between different parts of the brain.  This condition can be debilitating and life-threatening, particularly if left untreated, and its diagnosis is complex.

The information reviewed by PRAC showed that leukoencephalopathy can occur after a single dose of levamisole and that symptoms may develop up to several months after treatment. The review did not identify any measures to reduce the risk or any group of people who may be at…

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