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EMA introduces new measures to minimize risk of serious adverse effects associated with pseudoephedrine

The European Medicines Agency (EMA) has introduced new measures to minimize the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine-containing medications.

The EMA now recommends that pseudoephedrine-containing medications should not be used in patients with:

• Severe or uncontrolled hypertension

• Severe acute or chronic renal disease or failure

as these are risk factors for developing PRES or RCVS.

In addition, healthcare professionals should advise patients to stop using these medications immediately and seek treatment if they develop symptoms of either of these conditions (e.g., sudden onset of severe headache, nausea/vomiting, confusion, seizures, visual disturbances).

These rare conditions can reduce blood supply to the brain and result in serious and life-threatening complications. However, with prompt treatment symptoms usually resolve, and no fatal cases have been reported.

These recommendations follow a review of evidence and post-marketing surveillance safety data, which concluded that pseudoephedrine is associated with these conditions.

The risks of PRES and RCVS should be considered alongside other risks associated with pseudoephedrine-containing medications, including ischemic and cardiovascular events.

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