Moldova Pulls Levamisole Products After EU Safety Reassessment

Moldova's Medicines and Medical Devices Agency has ordered the withdrawal of all levamisole-containing products from the national pharmaceutical market, a direct consequence of a safety reassessment conducted at the European Union level. For manufacturers and QA leads holding marketing authorisations for legacy anthelmintic formulations, the decision signals how EMA pharmacovigilance findings translate into binding national regulatory action, often with limited transition time.

The withdrawal follows the identification of leukoencephalopathy, a serious central nervous system disorder, as a risk associated with levamisole use. The Agency concluded that no effective risk mitigation measures exist to restore a favourable benefit-risk balance for the treatment of helminthiasis. The decision explicitly names Decaris at the 50 mg and 150 mg dosages as the affected products in the Moldovan market.

The formal language of the withdrawal decision is instructive for regulatory affairs teams monitoring ICH Q10-aligned lifecycle management obligations: "In the absence of effective risk mitigation measures, the benefit-risk ratio of levamisole-containing products is no longer favorable for the treatment of helminthiasis." This framing reflects a benefit-risk methodology consistent with EMA post-marketing surveillance frameworks, and its adoption by a non-EU national agency underscores the reach of European pharmacovigilance decisions into neighbouring markets.

The Agency has directed patients and healthcare professionals to report any suspected adverse reactions through the national pharmacovigilance reporting system on its official website. Manufacturers with distribution exposure in Moldova or comparable markets operating under EU regulatory alignment should review their signal detection and variation management procedures accordingly.