Medicines containing levamisole will be withdrawn from the European market. The decision comes from the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), following a safety review that found that the benefit-risk balance is no longer favorable.
Why the EMA Ordered the Withdrawal of Levamisole
The PRAC (Pharmacovigilance Risk Assessment Committee), the EMA body responsible for the safety of medicines in the European Union, has recommended the withdrawal of all medicines containing levamisole.
After an in-depth analysis of the available data, experts concluded that the therapeutic benefits of the medicine no longer outweigh the potential health risks.
Under European regulations, when a medicine has side effects considered more significant than its expected benefits, health authorities may decide to suspend or withdraw its marketing authorization.
The Risk of Leukoencephalopathy
The main reason for the decision concerns the risk of developing leukoencephalopathy, a condition that affects the brain’s white matter.
White matter consists of nerve fibers covered with myelin, which are essential for the proper transmission of nerve signals. Damage to these structures can impair important neurological functions.
According to the EMA, levamisole-associated leukoencephalopathy is:
- Rare
- Potentially serious
- Possible even after a single dose of the medicine
Symptoms may appear within one day of taking the medicine or may develop several months after treatment.
What Was Levamisole Used For?
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