The National Agency for Food and Drug Administration and Control received a notification that on 6 April 2026, the Italian Medicines Agency (AIFA) endorsed a safety recommendation to withdraw medicines containing levamisole from the EU market.
This recommendation was issued by the European Medicines Agency (EMA) safety committee known as the Pharmacovigilance Risk Assessment Committee (PRAC) following an EU-wide review which concluded that the benefits of Levamisole no longer outweigh its risks for the treatment of parasitic worm infections in adults and children.
Levamisole is an anthelmintic agent that acts by stimulating nicotinic acetylcholine receptors in parasitic worms, causing paralysis and subsequent expulsion of the parasites.
The review identified and confirmed leukoencephalopathy as 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.
RISK-STATEMENT
It is important to note that the review did not identify any measures to reduce the risk or any group of people who may be at higher or lower risk of levamisole use.
PRODUCT DETAILS
The affected products in this safety communication involve all levamisole-containing medicines marketed in the European Union (EU).
NAFDAC will continue to monitor emerging safety data and may take further regulatory actions as necessary to protect public health in Nigeria.
Importers, distributors, retailers, healthcare professionals, and consumers should be cautious and vigilant throughout the supply chain to prevent the purchase or use of medicines containing Levamisole.
All medical products must be obtained from authorized or licensed suppliers. The authenticity and physical condition of these products should be carefully checked before use.
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.
Healthcare professionals should immediately review their stock in hospitals, clinics, and pharmacies. They must quarantine any stock containing Levamisole, discontinue the sale or distribution, and submit to the nearest NAFDAC office for regulatory action.
Furthermore, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of Levamisole to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: (09097630506) (09097630507) or the NAFDAC call centre on (0800-1-623322). For enquiries, call (0700-1-623322) or email: reforms@nafdac.gov.ng
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