2023-12-01 17:01:03
They are called Actifed Rhume, Dolirhume, Nurofen Rhume… Oral treatments for blocked noses are well on their way to remaining available in pharmacies, without a prescription. The pseudoephedrine they contain stimulates the heart rate and reduces the diameter of blood vessels, which decongests the nasal mucous membranes. This effect is not limited to the nose, but also affects the heart and the brain. It can therefore cause, in rare cases, cerebrovascular accidents (CVA) and myocardial infarction.
In February, the National Medicines Safety Agency (ANSM) requested a re-evaluation of these treatments from the European Medicines Agency (EMA). In October, the ANSM explicitly advised against using them. Friday 1is December, the EMA’s risk assessment committee, called PRAC, issued an opinion which certainly proposes new measures to limit cardiovascular risks, but without calling into question the availability of these drugs on the market. Another EMA committee must still give its opinion on pseudoephedrine, before the European Commission makes its final decision, not for several months.
Called to comment on the risk of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction (RCVS) associated with pseudoephedrine, the PRAC recommends that the molecule not be used by people with high blood pressure “severe or uncontrolled” or suffering from kidney disease. He also suggests that health professionals “recommend that their patients stop using these medications (…) if they develop symptoms of PRES or RCVS, such as sudden severe headache, feeling unwell, vomiting, confusion, seizures or vision changes.” Product information will be updated, the committee specifies.
“Missed opportunity”
In a press release, the ANSM considers that the PRAC “does not sufficiently take into account the seriousness of the adverse effects to which patients are unnecessarily exposed to relieve a mild symptom which benefits from safe alternatives”. “We expressed a divergent opinion to the committee during the vote on the conclusions,” underlines the agency. The PRAC’s opinion is “largely insufficient” and represents a “missed opportunity”also deplores Séverine Carré-Pétraud, editorial director of the specialized journal Prescribe. For her, “It is deplorable that it is up to caregivers to limit the risks.”
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