On April 6, 2026, Italy’s Medicines Agency formally endorsed the European Medicines Agency’s recommendation to withdraw all levamisole-containing drugs from European markets. This regulatory milestone represents a coordinated response to safety data indicating serious neurological adverse effects in patients using the antiparasitic medication.
The decision followed thorough pharmacovigilance assessment by the EMA’s Safety Committee, which evaluated clinical evidence and adverse event reports. Levamisole’s mechanism—modulating immune system function—has been implicated in its neurological side effect profile, leading regulators to determine that risks outweigh therapeutic benefits.
This EU-wide action demonstrates the robustness of European pharmacovigilance frameworks in identifying and responding to emerging drug safety signals. International drug regulators, including Nigeria’s NAFDAC, have issued corresponding public alerts to ensure healthcare providers and patients receive timely notification of this significant safety action.
Read the full article on GMJ Newsroom.
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