{"id":2892,"date":"2026-02-16T07:28:43","date_gmt":"2026-02-16T07:28:43","guid":{"rendered":"https:\/\/whmnews.ir\/En\/?p=2892"},"modified":"2026-02-16T07:28:43","modified_gmt":"2026-02-16T07:28:43","slug":"ema-recommends-withdrawal-of-marketing-authorisations-for-levamisole-medicines","status":"publish","type":"post","link":"https:\/\/whmnews.ir\/En\/index.php\/2026\/02\/16\/ema-recommends-withdrawal-of-marketing-authorisations-for-levamisole-medicines\/","title":{"rendered":"EMA recommends withdrawal of marketing authorisations for levamisole medicines"},"content":{"rendered":"

EMA recommends withdrawal of marketing authorisations for levamisole medicines<\/strong><\/p>\n

EMA\u2019s safety committee (PRAC) recommended that medicines containing levamisole be withdrawn from the EU market.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.<\/p>\n

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.\u00a0 This condition can be debilitating and life-threatening, particularly if left untreated, and its diagnosis is complex.<\/p>\n

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benefits of levamisole medicines no longer outweigh the risks and recommended that their marketing authorisations be withdrawn in the EU.<\/p>\n

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.<\/p>\n

EMA continuously monitors the safety of medicines authorised in the EU. When new evidence shows that a medicine\u2019s risks may outweigh its benefits, the Agency acts to protect public health. The recommendation to withdraw medicines containing levamisole reflects EMA\u2019s commitment to ensuring that medicines available in the EU meet robust standards of safety, effectiveness and quality.<\/p>\n

Information for patients<\/p>\n