2023-12-01 20:55:12
The National Medicines Safety Agency (ANSM) has once once more recommended not using certain cold medications despite the measures taken this Friday by the European Medicines Agency.
“The responses provided do not appear sufficient to protect patients.” It is “a divergent opinion” that the Medicines Agency issued to the European health authorities regarding anti-cold medications.
Last October, the ANSM (the National Medicines Safety Agency) warned of the risks of serious complications linked to the consumption of cold medications, namely: Actifed Rhume, Actifed Rhume day and night, Dolirhume Paracetamol and Pseudoephedrine, Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine, Humex Cold, Nurofen Cold, Rhinadvil Cold Ibuprofen/Pseudoephedrine and Rhinadvilcaps Cold Ibuprofen/Pseudoephedrine.
Contraindications from the European Medicines Agency
Faced with these alerts which have followed one another over the years, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended on Friday – to certain patients – not to use medications that decongest the nose to minimize the risk of serious complications.
“Pseudoephedrine-containing medicines should not be used in patients with severe or uncontrolled (untreated or resistant to treatment) high blood pressure, or severe acute (sudden) or chronic (long-term) kidney failure “, indicates the EMA.
Pseudoephedrine is a stimulant often used as a decongestant for colds or allergies, but it is associated with risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), rare effects that can cause a reduction in blood supply to the brain, which can cause serious and life-threatening complications.
“Healthcare professionals should advise patients to immediately stop using these medications and seek treatment if they develop symptoms of PRES or RCVS, such as sudden onset severe headache, nausea , vomiting, confusion, convulsions and visual disturbances,” adds its Pharmacovigilance Risk Assessment Committee (PRAC).
Finally, the PRAC recommends updating the information on all medicines containing pseudoephedrine to include these risks.
Insufficient measures for the ANSM
“If the PRAC proposes measures to reduce the risks […] with the addition of contraindications and warnings in particular, it does not sufficiently take into account the seriousness of the adverse effects to which patients are unnecessarily exposed to relieve a benign symptom which benefits from safe alternatives”, writes the ANSM in a press release on its website.
“Accordingly, we maintain our position […] not to recommend the use of vasoconstrictors given the serious associated risks”, concludes the ANSM.
The EMA scientific committee (CHMP) will examine the recommendation made by the PRAC in the coming months in order to decide on the new benefit/risk ratio of these medicines. It will forward its opinion to the European Commission for decision.
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