Warning about nasal congestion medications… “dangerous” for these patients

The Agency’s Pharmacovigilance Risk Assessment Committee stressed the need to… "Healthcare professionals advise patients to immediately stop using these medications and seek treatment if they develop symptoms of reversible posterior encephalopathy syndrome and reversible cerebral vasoconstriction syndrome, such as sudden severe headache, nausea, vomiting, convulsions, and visual disturbances.".

The committee also recommended updating information on all medications containing pseudoephedrine to include these risks.

The Scientific Committee of the European Medicines Agency is expected to study it

In the coming months, the risk assessment committee will recommend, provided that it transmits the opinion it reaches to the European Commission to take a final decision.

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The European Medicines Agency stated on its website that “patients with severe or uncontrolled high blood pressure (untreated or resistant to treatment), or acute (sudden) or chronic (long-term) kidney failure should not use medicines containing pseudoephedrine.” “.

Pseudoephedrine is a stimulant often used as a decongestant for colds or allergies, but it can cause posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome, two rare effects that can lead to a decrease in blood flow to the brain, which can cause serious, fatal complications.

Medicines containing pseudoephedrine are available in European Union countries under different brand names, including “Activade,” “Aspirin Complex,” “Clarinase,” “Omex Rom,” “Nurofen Cold & Flu,” and “Airinase.”

The agency’s Pharmacovigilance Risk Assessment Committee stressed the need for “health care professionals to advise patients to immediately stop using these medications and seek treatment if they develop symptoms of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome, such as sudden severe headache, nausea, vomiting, convulsions, and visual disturbances.” .

The committee also recommended updating information on all medications containing pseudoephedrine to include these risks.

The Scientific Committee of the European Medicines Agency is expected to study it

In the coming months, the risk assessment committee will recommend, provided that it transmits the opinion it reaches to the European Commission to take a final decision.