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?

• All levamisole-based medicines will be removed across the EU
• National health authorities will implement the recall
• Updated lists of affected medications have been issued

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