Public Alert No. 030/2026: Alert on the Withdrawal of Levamisole-Containing Medicines as endorsed by the Italian Medicines Agency (AIFA) over serious Neurological risks

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued Public Alert No. 030/2026, notifying the Nigerian public of the withdrawal of all levamisole-containing medicines from the European Union (EU) market. This significant regulatory action, endorsed by the Italian Medicines Agency (AIFA) following a recommendation from the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), stems from a comprehensive EU-wide review. The review concluded that the benefits of levamisole, primarily an anthelmintic, no longer outweigh its risks, particularly the rare but serious neurological side effect of leukoencephalopathy. This alert underscores NAFDAC's commitment to safeguarding public health through international pharmacovigilance and necessitates immediate action from pharmaceutical stakeholders in Nigeria.

The landscape of pharmaceutical regulation is increasingly globalised, with national agencies often responding to safety alerts originating from international bodies. In a recent and critical development, the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria issued Public Alert No. 030/2026, drawing attention to a significant regulatory decision made in the European Union. This alert concerns the withdrawal of all medicines containing levamisole from the EU market, a decision endorsed by the Italian Medicines Agency (AIFA) on April 6, 2026, following a recommendation from the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC).

The core reason for this withdrawal is the confirmed risk of leukoencephalopathy, a rare but severe neurological condition, which has led the PRAC to conclude that the benefits of levamisole no longer outweigh its risks for the treatment of parasitic worm infections. This article delves into the legal and regulatory implications of this alert for legal practitioners and pharmaceutical stakeholders in Nigeria, examining the underlying scientific rationale, the regulatory frameworks involved, and the necessary compliance actions.

Levamisole is an anthelmintic agent historically used to treat parasitic worm infections in both humans and animals, acting by stimulating nicotinic acetylcholine receptors in parasitic worms, leading to paralysis and expulsion. Beyond its therapeutic use, levamisole has also been noted for its immunomodulatory properties and, notably, as a common adulterant in illicit drugs like cocaine, where it can exacerbate health risks.

The European Medicines Agency (EMA) and its Pharmacovigilance Risk Assessment Committee (PRAC) play a pivotal role in the EU's drug safety monitoring. The EMA operates under a robust pharmacovigilance legislative framework, primarily governed by Directive 2010/84/EU and Regulation (EU) No 1235/2010, which mandate continuous monitoring of drug safety and allow for regulatory actions, including market withdrawal, when a medicine's benefit-risk balance becomes unfavourable. National agencies like the Italian Medicines Agency (AIFA) implement these EU-wide recommendations within their respective jurisdictions.

In Nigeria, NAFDAC is the principal regulatory body responsible for safeguarding public health by regulating and controlling the manufacture, importation, exportation, distribution, advertisement, sale, and use of various regulated products, including drugs. The NAFDAC Act Cap N1 LFN 2004 provides the legal framework for its operations, which include pharmacovigilance, post-marketing surveillance, and the management of product recalls. NAFDAC's mandate extends to responding to international safety alerts to protect the Nigerian populace from harmful products.

The EMA's PRAC initiated a review of levamisole-containing medicines due to concerns over leukoencephalopathy, a severe condition that damages the white matter of the brain. The review, which included reported serious cases and published medical literature, confirmed leukoencephalopathy as a rare but serious side effect. Symptoms can include muscle weakness, difficulty speaking, confusion, and impaired coordination, with onset potentially occurring after a single dose and developing over several months. Crucially, the review found no identifiable measures to mitigate this risk or specific patient groups for whom the drug could be safely used. Given that alternative treatments for parasitic worm infections exist and the unpredictable, life-threatening nature of leukoencephalopathy, the PRAC concluded that levamisole's benefits no longer justified its risks, leading to the recommendation for withdrawal.

NAFDAC's Public Alert No. 030/2026 serves as a direct response to this international safety concern, demonstrating the agency's proactive approach to pharmacovigilance and its commitment to aligning with global best practices in drug safety. Under the NAFDAC Act, the agency possesses broad powers to regulate and control drugs, including the power to order the withdrawal of products deemed unsafe. The alert specifically instructs importers, distributors, retailers, and healthcare professionals to exercise caution, quarantine existing stock, discontinue sale or distribution, and submit affected products to the nearest NAFDAC office for regulatory action.

Legal practitioners advising pharmaceutical companies, distributors, and healthcare providers must ensure strict compliance with this alert. Failure to adhere to NAFDAC's directives could lead to severe penalties, including product seizure, fines, and potential criminal prosecution under the NAFDAC Act. Furthermore, the withdrawal raises potential product liability concerns for manufacturers and distributors who may have supplied levamisole-containing products, particularly if adverse events linked to the drug are reported in Nigeria. The challenge in Nigeria is compounded by the potential for unregistered or illicitly imported levamisole, especially given its use as an adulterant, making comprehensive market surveillance and enforcement critical. NAFDAC's emphasis on obtaining medical products from authorized suppliers highlights the importance of supply chain integrity in preventing the circulation of harmful substances.

The withdrawal of levamisole-containing medicines from the EU market, and NAFDAC's subsequent alert, represents a critical development in drug safety that demands immediate attention from all stakeholders in Nigeria's pharmaceutical sector. Legal practitioners must proactively advise their clients on the stringent compliance requirements outlined by NAFDAC, including the immediate cessation of sale, distribution, and the quarantine of all levamisole products. This incident underscores the interconnectedness of global pharmacovigilance efforts and the imperative for national regulatory bodies to act swiftly on international safety signals.

Going forward, practitioners should monitor NAFDAC's enforcement actions and any further guidance issued regarding the disposal or recall process. This event also serves as a reminder for pharmaceutical companies to review their internal pharmacovigilance systems, supply chain due diligence, and product liability exposures. The protection of public health remains paramount, and adherence to regulatory directives is not merely a legal obligation but a fundamental ethical responsibility for all involved in the provision of medicines.