Levamisole: EMA Orders Withdrawal of Medicines Due to Rare but Serious Risk of Brain Damage

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