They are called Actifed Rhume, Dolirhume, Nurofen Rhume… Oral treatments for nasal congestion are on track to continue to be available in pharmacies without a prescription. The pseudoephedrine it contains stimulates the heart rate and reduces the diameter of the blood vessels, thereby decongesting the nasal mucous membranes. This effect is not only limited to the nose, but also affects the heart and brain. Therefore, cerebrovascular accidents (CVA) and myocardial infarction may occur in rare cases.
In February, the National Medicines Safety Agency (ANSM) requested that the European Medicines Agency (EMA) reassess these treatments. In October, the ANSM specifically advised against their use. Friday 1stum In December, the EMA’s risk assessment committee, known as PRAC, issued a statement which, while proposing new measures to limit cardiovascular risks, does not call into question the availability of these drugs on the market. Before the European Commission makes its final decision, another EMA committee must give its opinion on pseudoephedrine, not for several months.
The PRAC has been asked to comment on the risk of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction (RCVS) associated with pseudoephedrine and recommends that the molecule should not be used by people with high blood pressure “severe or uncontrolled” or suffer from kidney disease. He also suggests that health professionals “Recommend your patients to stop using these medications (…) if they develop symptoms of PRES or RCVS, such as: B. sudden severe headache, malaise, vomiting, confusion, seizures or visual disturbances.” Product information will be updated, the committee states.
“Missed opportunity”
In a press release, the ANSM is of the opinion that the PRAC “Does not sufficiently take into account the severity of side effects to which patients are unnecessarily exposed to relieve a mild symptom that benefits from safe alternatives.” “We expressed a dissenting opinion to the committee when voting on the conclusions” emphasizes the agency. The PRAC’s opinion is “largely inadequate” and represents a “missed opportunity”Séverine Carré-Pétraud, editorial director of the specialist magazine, also regrets Prescribe. For her, “It is unfortunate that it is incumbent on carers to limit the risks.”
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