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Following a comprehensive safety review, EMA and its Pharmacovigilance Risk Assessment Committee (PRAC) have moved to significantly alter the regulatory status of levamisole-based therapies.¹ The committee noted in a press release that, “Leukoencephalopathy [has been] confirmed as a serious side effect of levamisole.”¹ Consequently, “EMA’s safety committee, the PRAC, has recommended that medicines containing levamisole be withdrawn from the EU market.”¹
Why Was There a Negative Conclusion for the Benefit-Risk Assessment for Levamisole?
The primary concern lies in the nature of the identified risk relative to the condition being treated.¹…