Other safety alerts
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| European Union: European Medicines Agency recommends withdrawal of marketing authorisations for levamisole medicines |
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European Medicines Agency (EMA) announces that EMA’s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market. This follows an EU-wide review which concluded that the benefits of these medicines no longer outweigh their risks for the treatment of parasitic worm infections in adults and children.
Levamisole is active against intestinal nematodes and appears to act by paralysing susceptible worms which are subsequently eliminated from the intestines. In particular, levamisole is effective in the treatment of ascariasis. It is also used in hookworm infections.
The review confirmed that leukoencephalopathy is a rare but serious side effect of levamisole. Leukoencephalopathy damages the white matter of the brain, which is made of nerve fibres covered by myelin, a protective layer that allows efficient communication between different parts of the brain. This condition can be debilitating and life-threatening, particularly if left untreated, and its diagnosis is complex.
The information reviewed by PRAC showed that leukoencephalopathy can occur after a single dose of levamisole and that symptoms may develop up 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 or lower risk. In addition, other medicines are authorised in the EU for the treatment of parasitic worm infections. Given that levamisole medicines are used to treat mild parasitic worm infections, and that levamisole-induced leukoencephalopathy is a serious condition with an unpredictable onset, PRAC concluded that the benefits of levamisole medicines no longer outweigh the risks and recommended that their marketing authorisations be withdrawn in the EU.
The PRAC recommendation is based on the assessment of new data gathered through the continuous safety monitoring of medicines authorised in the EU. These included reports of serious cases of leukoencephalopathy and demyelination of the central nervous system (loss of myelin in the brain and spinal cord) following use of levamisole, as well as a review of the published scientific literature. The PRAC also considered input from a panel of independent experts in infectious diseases and neurologists, and from the World Health Organization.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisations-levamisole-medicines
In Hong Kong, there is no registered pharmaceutical product containing levamisole. Related news was previously issued by EMA, and was posted on the Drug Office website on 06 Sep 2025.
Ends/ Saturday, February 14, 2026
Issued at HKT 12:00
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