Experts at the European Medicines Agency (EMA) have recommended withdrawing marketing authorizations for drugs containing levamisole, used in the treatment of parasitic worm infections, after assessments showed that the risks outweigh the benefits. The decision follows an analysis carried out by the Pharmacovigilance Risk Assessment Committee (PRAC) within the EMA.
The committee found that levamisole can cause leukoencephalopathy, a rare but severe condition that affects the white matter of the brain. Symptoms can appear even after taking a single dose and can appear from one day to several months after treatment.
The review was based on serious case reports, including off-label, and the literature, also consulting the opinions of independent experts in infectious diseases and neurology, as well as the World Health Organization (WHO) view.
“The assessment did not identify risk-reducing measures or categories of people at higher or lower risk. Levamisole treats mild parasitic infections and the induced leukoencephalopathy is serious and unpredictable. Therefore, the benefits no longer outweigh the risks and the PRAC recommends withdrawal of marketing authorizations in the EU”the EMA press release states.
As a result, medicines containing levamisole will no longer be available on the European market. Patients who have taken such drugs are advised to seek medical advice immediately if symptoms such as muscle weakness, difficulty speaking, confusion or problems coordinating movements occur.
For healthcare professionals, the EMA states that neurological symptoms associated with leukoencephalopathy may include muscle weakness, language impairment, cognitive impairment, ataxia and paresis.
Levamisole is a broad-spectrum anthelmintic used to treat parasitic worm infections in adults and children, including Ascaris lumbricoides, Necator americanus, Ancylostoma duodenale, Strongyloides stercoralis and Trichostrongylus colubriformis. It paralyzes the musculature of the parasite, facilitating its elimination from the digestive tract. Levamisole medicines are available as tablets taken orally, usually in a single dose, and were authorized in Romania, Hungary, Lithuania and Latvia under the names Decaris and Levamisol Arena.
The evaluation was initiated at the request of the National Agency for Medicines and Medical Devices in Romania (ANMDMR) and is to be submitted to the Coordination Group for Mutual Recognition and Decentralized Procedures (CMDh), which will adopt a final position at the EU level.
The EMA constantly monitors the safety of medicines authorized in the EU and intervenes when data indicate that the risks outweigh the benefits, applying strict standards of safety, efficacy and quality at European level.
