EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine

View source ↗

Summary

EMA confirms measures to minimise serious brain-related side effects (PRES and RCVS) with medicines containing pseudoephedrine.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Posterior Reversible Encephalopathy Syndrome
• Reversible Cerebral Vasoconstriction Syndrome

Snippet

On 25 January 2024, EMA’s human medicines committee (CHMP) endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.