“The responses provided do not appear sufficient to protect patients.” This is “a divergent opinion” that the Medicines Agency issued to European health authorities on cold medicines.
Last October, the ANSM (National Agency for Drug Safety) warned about the risks of serious complications related to the consumption of cold medicines, 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 of the European Medicines Agency
Given these alerts that have occurred 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.
“Medicines containing pseudoephedrine should not be used in patients with severe or uncontrolled (untreated or refractory) high blood pressure, or with severe acute (sudden) or chronic (long-term) kidney failure,” says 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 stop using these medications immediately and seek treatment if they develop symptoms of PRES or RCVS, such as sudden onset of severe headache, nausea, vomiting, confusion, seizures, and visual disturbances,” adds their Pharmacovigilance Risk Assessment Committee (PRAC).
Finally, the PRAC recommends updating the information for 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, does not sufficiently take into account the severity of the adverse effects to which patients are unnecessarily exposed in order to alleviate a benign symptom that benefits from safe alternatives,” writes the ANSM in a press release. on their website.
“As a result, we maintain our position […] not 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 to decide on the new benefit/risk ratio of these medicines. It will send its opinion to the European Commission for a decision.
Source: BFM TV
