EMA Recommends EU Withdrawal of Levamisole Medicines

Following a comprehensive safety review, EMA and its Pharmacovigilance Risk Assessment Committee (PRAC) have moved to significantly alter the regulatory status of levamisole-based therapies.¹ The committee noted in a press release that, "Leukoencephalopathy [has been] confirmed as a serious side effect of levamisole.”¹ Consequently, "EMA’s safety committee, the PRAC, has recommended that medicines containing levamisole be withdrawn from the EU market.”¹

Why Was There a Negative Conclusion for the Benefit-Risk Assessment for Levamisole?

The primary concern lies in the nature of the identified risk relative to the condition being treated.¹ The committee noted that "this follows an EU-wide safety review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections due to the risk of leukoencephalopathy, a rare but serious side effect of levamisole that affects the brain’s white matter.”¹ This type of regulatory action highlights the need to maintain rigorous post-market surveillance.

The difficulty in managing this specific safety profile is exacerbated by its lack of predictability. According to the review, "symptoms of leukoencephalopathy may occur after a single dose of levamisole and may develop within one day to several months after treatment.”¹ Furthermore, the investigation failed to find a way to mitigate these dangers through patient screening or dosage adjustments, noting that "the review did not identify any measures to reduce the risk or any group of people who may be at higher risk of developing leukoencephalopathy with levamisole use.”¹ From a lifecycle management perspective, the inability to define a safe use case for a product treating minor ailments often leads to its removal from the market. As the committee summarized, "Overall, considering that levamisole medicines are used to treat mild parasitic worm infections and that levamisole-induced leukoencephalopathy is a serious condition with an unpredictable onset, the benefit–risk balance of these medicines was considered negative.”¹

What Are the Immediate Regulatory Requirements for Marketing Authorization Holders?

The recommendation for withdrawal, which affects products such as Decaris and Levamisol Arena in specific EU territories, necessitates immediate action regarding communication with the medical community.² PRAC has already endorsed a Direct Healthcare Professional Communication (DHPC) to facilitate this process. This involves a coordinated effort across various member states of the EU. The dissemination of the DHPC will be the responsibility of the marketing authorization holders, who must ensure information is distributed "according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.”¹

This situation serves as a reminder to the industry that even rare adverse events can lead to the total withdrawal of marketing authorizations if they involve serious neurological conditions like leukoencephalopathy.² PRAC continues to utilize tools such as periodic safety update reports and risk management plans to identify such safety signals and conduct the necessary referrals to resolve concerns over a medicine’s safety profile.

References

1. European Medicines Agency (EMA). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9–12 February 2026. EMA website. Published 13 Feb 2026. Accessed 13 Feb 2026.
2. European Medicines Agency (EMA). EMA recommends withdrawal of marketing authorisations for levamisole medicines. EMA website. Published 13 Feb 2026. Accessed 13 Feb 2026.