- EMA's PRAC recommends withdrawing levamisole medicines from the EU market.
- Leukoencephalopathy, a serious side effect, can occur after a single levamisole dose.
- No measures identified to reduce levamisole's risk or identify high-risk groups.
- Other medicines are available in the EU for treating parasitic worm infections.
Withdrawal Recommendation
The European Medicines Agency's safety committee, PRAC, has recommended the withdrawal of levamisole-containing medicines from the EU market. This decision follows a comprehensive review indicating that the risks of these medicines, particularly for treating parasitic worm infections, outweigh their benefits.
Serious Side Effects
The review highlighted leukoencephalopathy as a rare but severe side effect of levamisole. This condition affects the brain's white matter and can be debilitating or life-threatening. It can occur after a single dose, with symptoms potentially developing months later.
Risk Assessment
PRAC's assessment found no effective measures to mitigate the risk of leukoencephalopathy or identify specific high-risk groups. Given the availability of alternative treatments for parasitic infections, the committee concluded that levamisole's risks are unjustifiable.
Data and Expert Input
The recommendation is based on new data from continuous safety monitoring, including reports of serious cases and a review of scientific literature. Input from infectious disease experts, neurologists, and the World Health Organization was also considered.
