On February 13, 2026, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended the withdrawal of all levamisole-containing medicines from the European Union market.
The trigger was not a minor safety update. It was a rare but potentially devastating neurological condition — leukoencephalopathy, a disorder affecting the brain’s white matter. After reviewing accumulated pharmacovigilance data, PRAC concluded that the risk could not be adequately mitigated through warnings, dose adjustments, or monitoring. The benefit–risk balance, in their assessment, had turned negative.
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