Why the Withdrawal Was Ordered
The European Medicines Agency (EMA) has decided to withdraw all medicines containing levamisole from the European market.
This decision follows a safety review by the Pharmacovigilance Risk Assessment Committee (PRAC).
After analyzing available data, experts concluded:
- The risks now outweigh the benefits
- European law allows withdrawal when a drug’s safety profile becomes unfavorable
Main Concern: Risk of Leukoencephalopathy
The key issue is the risk of Leukoencephalopathy, a condition affecting the brain’s white matter.
Why this matters:
- White matter enables communication between brain regions
- Damage can impair neurological function
According to EMA findings:
- The condition is rare but serious
- It can occur even after a single dose
- Symptoms may appear:
- Within 24 hours
- Or months after treatment
What Was Levamisole Used For?
Levamisole was mainly prescribed to treat:
- Mild parasitic worm infections
Because these conditions are generally not severe, the EMA determined:
The neurological risks are too high compared to the benefits
What Happens Now?
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