Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 February 2026

13 February 2026

PRAC concludes safety review of levamisole, a medicine used to treat parasitic worm infections News Human Pharmacovigilance

PRAC recommends withdrawal of marketing authorisations for levamisole medicines

Leukoencephalopathy confirmed as a serious side effect of levamisole

EMA’s safety committee, the PRAC, has recommended that medicines containing levamisole be withdrawn from the EU market. 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.

The information reviewed showed that symptoms of leukoencephalopathy may occur after a single dose of levamisole and may develop within one day to several months after treatment. 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. 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.

More information is available in EMA’s public health communication.

New safety information for healthcare professionals

Levamisole-containing medicines will no longer be available in the EU

PRAC endorsed a direct healthcare professional communication (DHPC) to inform healthcare professionals of its recommendation to withdraw levamisole medicines from the EU market due to the risk of leukoencephalopathy (see above).

Healthcare professionals should be aware that symptoms of leukoencephalopathy may occur after a single dose of levamisole and may develop within one day to several months after treatment.

The DHPC for levamisole-containing medicines will be disseminated to relevant healthcare professionals by the marketing authorisation holders, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in EU Member States.

Agenda

Agenda of the PRAC meeting 9-12 February 2026

Draft Reference Number: EMA/PRAC/15618/2026 English (EN) (549.72 KB - PDF)

First published:

09/02/2026

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PRAC statistics: February 2026

PRAC statistics: February 2026

English (EN) (172.98 KB - PDF)

First published:

13/02/2026

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Concluded referrals

• Levamisole-containing medicinal products

Glossary

• Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under ' Signal management '.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under ' Periodic safety update reports: questions and answers '.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans '.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under ' Post-authorisation safety studies '.
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.

Related content

• EMA recommends withdrawal of marketing authorisations for levamisole medicines
• Pharmacovigilance Risk Assessment Committee (PRAC): 9 - 12 February 2026
• Pharmacovigilance Risk Assessment Committee (PRAC)

Related documents

Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities

Reference Number: EMA/899164/2022 Rev.4 English (EN) (491 KB - PDF)

First published:

05/10/2012

Last updated:

03/12/2025

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