The National Agency for Food and Drug Administration and Control (NAFDAC) has directed healthcare professionals in Nigeria to withdraw levamisole-containing medicines following an international safety review that confirmed a rare but serious neurological risk associated with the anthelmintic.

In a Dear Healthcare Provider communication dated 3 September 2026, NAFDAC said the action followed notification of a recommendation endorsed by European regulators to withdraw levamisole-containing medicines from the European Union market after a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

The review concluded that the benefits of levamisole no longer outweighed its risks when used to treat parasitic worm infections in adults and children.

What prompted the withdrawal?

The European review focused on leukoencephalopathy, a disorder involving the brain's white matter.

The EMA said its review confirmed leukoencephalopathy as a rare but serious adverse effect of levamisole. The condition can damage the white matter of the brain and may be debilitating or life-threatening. Importantly, the review found that the condition could occur after a single dose, with symptoms potentially appearing several months after treatment.

The review was based on newly assessed safety data, including reports of serious cases of leukoencephalopathy and demyelination of the central nervous system, alongside evidence from published scientific literature. EMA also considered input from independent infectious-disease and neurology experts and the World Health Organization.

The PRAC did not identify measures that could adequately reduce the risk, nor a patient group that could be considered at lower risk. Other medicines are also available in the EU for the treatment of parasitic worm infections.

What has happened in Europe?

The EMA's safety committee recommended withdrawal of levamisole marketing authorisations, with the EU's Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsing the recommendation in March 2026. EMA subsequently published its formal referral information on 27 March.

The Italian Medicines Agency (AIFA) separately confirmed the European recommendation on 27 March 2026, stating that the withdrawal was related to the risk of leukoencephalopathy. AIFA also noted that no human medicinal products containing levamisole were authorised in Italy.

EMA later published a direct healthcare professional communication on 16 April 2026 concerning the withdrawal and the risk of leukoencephalopathy.

What is NAFDAC telling healthcare professionals?

NAFDAC's Nigerian communication identifies all medicines containing levamisole as affected.

Healthcare professionals have been instructed to:

• review existing stocks in hospitals, clinics and pharmacies;

• quarantine identified levamisole-containing products;

• discontinue their sale, supply, dispensing or use;

• submit affected products to the nearest NAFDAC office for appropriate regulatory action; and

• advise patients currently using levamisole-containing products to discontinue use and seek medical evaluation where appropriate.

NAFDAC also advises healthcare professionals to monitor patients for symptoms suggestive of leukoencephalopathy, including muscle weakness, difficulty speaking, confusion and impaired coordination or movement.

Levamisole is still listed in Nigeria's regulatory database

The regulatory development is particularly relevant in Nigeria because NAFDAC's product database shows that levamisole-containing medicines have been registered for use in the country.

For example, NAFDAC's Greenbook lists Samtrex Tablet 40 mg, containing levamisole hydrochloride, with an approval date of 28 September 2021 and an expiry date of 27 September 2026. The product is listed as an over-the-counter medicine.

The database also contains other levamisole products, including Evikt Tablet 40 mg, with an approval date of 28 April 2026. Its current database status is listed as inactive.

These records underscore why NAFDAC's latest directive is significant for pharmacies, hospitals and other medicine outlets: products containing the active ingredient may have been present in the Nigerian supply chain under different brand names.

What pharmacists and healthcare facilities should do

For pharmacists and other healthcare professionals, the immediate issue is identifying whether levamisole-containing products remain in stock.

NAFDAC's directive is not limited to a particular brand. It asks healthcare professionals to review stock for medicines containing levamisole, quarantine identified products and discontinue their sale, supply, dispensing or use.

Facilities should therefore check product labels, active ingredients and relevant stock records rather than relying solely on brand names.

NAFDAC has also asked facilities to report suspected adverse drug reactions associated with levamisole through its approved pharmacovigilance channels.

What patients should know

Patients who have previously taken levamisole should not assume that they have developed a neurological complication simply because they used the medicine.

The regulatory concern relates to a rare adverse effect, and the European review found that its onset can be unpredictable.

NAFDAC, however, advises patients currently using levamisole-containing medicines to discontinue use and seek medical evaluation where appropriate. Patients experiencing symptoms such as weakness, difficulty speaking, confusion or problems with coordination should seek medical attention.

What this means for levamisole use in Nigeria

The NAFDAC communication brings the European safety finding into the Nigerian regulatory environment.

The underlying evidence does not suggest that levamisole suddenly became unsafe in September 2026. Rather, European regulators conducted a formal safety review after accumulating evidence on serious neurological reactions and concluded that the medicine's benefits no longer outweighed its risks for the treatment of parasitic worm infections.

NAFDAC's September communication now directs healthcare professionals in Nigeria to take action on levamisole-containing medicines.

For the Nigerian medicines supply chain, the practical priority is therefore to identify affected stock, prevent further dispensing or use in line with NAFDAC's instruction, and ensure suspected adverse reactions are reported through the pharmacovigilance system.

Pharmacy Times Nigeria will continue to monitor further regulatory guidance from NAFDAC on levamisole-containing medicines.