NAFDAC issues alert on Levamisole over severe brain risks following EU ban

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an urgent public alert warning Nigerians against the purchase, distribution, and use of medicines containing levamisole, an anti-worm medication, due to severe neurological risks.

The public alert (No. 030/2026) follows a recent safety recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), which was officially endorsed by the Italian Medicines Agency (AIFA) on April 6, 2026, to withdraw all levamisole-containing drugs from the European market.

According to the global review, the benefits of the drug no longer outweigh its severe health risks for both adults and children.

Levamisole is traditionally used as an anthelmintic agent, a medication used to treat parasitic worm infections by paralyzing and expelling worms from the body. However, the international safety review confirmed a direct link between the drug and a rare but life-threatening brain condition.

“The review identified and confirmed leukoencephalopathy as a rare but serious side effect of levamisole. Leukoencephalopathy damages the white matter of the brain. This condition can be debilitating and life-threatening, particularly if left untreated, and its diagnosis is complex,” the review read.

Health experts however noted that there are currently no known measures to mitigate this risk, nor is there any specific group of people who are safer from these side effects than others.

In light of this development, NAFDAC has urged importers, distributors, retailers, healthcare professionals, and consumers across Nigeria to be highly vigilant throughout the pharmaceutical supply chain.

The regulatory agency advised consumers who have recently taken levamisole-containing medicines to immediately stop using them and seek urgent medical attention if they experience symptoms such as muscle weakness, difficulty speaking, confusion, or challenges with coordination and movement.

Healthcare professionals in hospitals, clinics, and pharmacies have also been directed to immediately audit their inventory. They must quarantine any remaining stock containing levamisole, halt its sale or distribution, and hand it over to the nearest NAFDAC office for regulatory action.

NAFDAC stated that it will continue to monitor emerging safety data and take further regulatory steps to protect public health in Nigeria. Nigerians are encouraged to report any adverse drug reactions via the nearest NAFDAC office or through the agency’s official e-reporting platforms.