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The National Agency for Food and Drug Administration and Control (NAFDAC) has warned healthcare professionals, importers, distributors and consumers against the purchase, sale and use of medicines containing Levamisole following safety concerns linked to a rare but potentially life-threatening brain disorder.
In a public safety alert, the agency said it received a notification that, on April 6, 2026, the Italian Medicines Agency (AIFA) endorsed a recommendation to withdraw all medicines containing Levamisole from the European Union market.
According to NAFDAC, the recommendation followed an extensive review by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the medicine’s risks now outweigh its benefits in treating parasitic worm infections in both adults and children.
“The review identified and confirmed leukoencephalopathy as a rare but serious side effect of levamisole,” the agency said.
NAFDAC explained that leukoencephalopathy is a condition that damages the brain’s white matter—the network of nerve fibres responsible for communication between different parts of the brain.
“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,” NAFDAC noted.
Levamisole is an anthelmintic medicine commonly used to treat parasitic worm infections by paralysing the worms, allowing them to be expelled from the body.
The agency noted that the European safety review found no practical measures to reduce the risk associated with the medicine and did not identify any patient category at higher or lower risk of developing the serious side effect.
Although the withdrawal recommendation applies to all Levamisole-containing medicines marketed within the European Union, NAFDAC said it would continue monitoring emerging safety data and could take further regulatory action in Nigeria if necessary.
The regulator urged importers, distributors, retailers, healthcare professionals and consumers to remain vigilant throughout the pharmaceutical supply chain to prevent the purchase or use of medicines containing Levamisole. It also advised Nigerians to obtain medicines only from authorised or licensed suppliers and to carefully verify the authenticity and physical condition of all medical products before use.
The agency further advised anyone who has recently taken medicines containing Levamisole and experiences symptoms such as muscle weakness, difficulty speaking, confusion, or problems with coordination and movement to stop using the medicine immediately and seek medical attention.
“Consumers who have purchased or recently taken medicines containing Levamisole and are experiencing any of the following symptoms: muscle weakness, difficulty speaking, confusion, or challenges with coordination and movement should stop using the product immediately and consult a qualified healthcare professional,” the statement said.
NAFDAC also directed healthcare professionals to inspect their inventories in hospitals, clinics and pharmacies without delay.
