2023-10-23 15:36:24
As in previous years, the National Agency for the Safety of Medicines and Health Products (ANSM) recommends once morest using tablets once morest this disease.
As the mercury gradually drops as winter approaches, the common cold is making a comeback. Runny nose, cough, hoarse throat, watery eyes… These symptoms, common at this time of year, are well known to everyone. To combat the disease and relieve its symptoms, patients may be tempted to swallow a tablet from a trusted brand. But it’s a mistake, alert, this Sunday, the authorities.
In a press release, the National Agency for the Safety of Medicines and Health Products (ANSM) recalls that the use of these products such as Dolirhume, Humex or Actifed is not without risk. “Myocardial infarction and stroke may occur following use of vasoconstrictor medications (pseudoephedrine) to relieve cold symptoms“. An admittedly rare risk – 307 serious cases between 2012 and 2018, according to the ANSM, cited by The Parisian -, more “these events can occur regardless of the dose and duration of treatment“. Recent data “report cases of posterior reversible encephalopathy syndromes (PRES) and reversible cerebral vasoconstriction syndromes (RCVS) following taking an oral vasoconstrictor containing pseudoephedrine», Explains the agency. She therefore prefers to advise once morest the use of these vasoconstrictor drugs, which are “available without a prescription and are often subject to inappropriate use», in oral form.
Only tablets, supplied without a prescription, are covered by this warning. Instead of these medications, the ANSM points out that colds normally heal in less than ten days, without any help. Patients who wish to alleviate symptoms that interfere with their daily lives can also use “suitable washing solutions” in the nose, such as physiological serum or sea water sprays. They must also drink enough, sleep with their head elevated, and maintain a temperature at home between 18 and 20 degrees, while ventilating the rooms.
This alert, launched in partnership with numerous actors, such as “the College of General Medicine, the National Professional ENT Council, as well as the National Order of Pharmacists and community pharmacists’ unions”, is not the first of its kind. For several years, the authorities have tried to limit the use of these drugs, the risks of which, associated with the presence of pseudoephedrine, are known. The efforts are bearing fruit: box sales have collapsed from sixteen million in 2010 to three million eleven years later.
In 2018, advertisements for these products had been banned, and in 2020 the ANSM suggested that patients wishing to take these medications talk regarding it with their pharmacist, so that the latter can advise or not recommend this product and alert them on risk factors and complications. The dosage must be respected, the treatment must not exceed five days, and vasoconstrictors must not be used in children under fifteen years of age, nor during pregnancy, nor in the case of breastfeeding. “Pay attention to symptoms that may indicate the occurrence of a stroke or myocardial infarction», also recommended the ANSM.
«Other restrictive measures might be taken to protect patients»: last February, the ANSM requested the re-evaluation of these drugs on a European scale. The marketing authorizations were in fact issued by Europe, so it is up to it to withdraw them, argues the French agency. The professional organization NèreS, which represents pharmaceutical laboratories producing and marketing products sold without a prescription, denounced « premature and alarmist communication,”‘amazing’that the ANSM does not respect the procedure that it itself initiated and communicates before even having obtained the conclusions of the European Pharmacovigilance Committee».
« The procedure, which began in February 2023, continuesindicates for its part lANSM. In the meantime, the reinforced surveillance put in place in France is maintained and other restrictive measures might be taken to protect patients. » This would not be quite a first: in 2022, the agency suspended the marketing of cough syrups containing pholcodine, due to a risk of cross allergy with curares, pending a re-evaluation by the European health authorities. Their marketing authorizations were definitively withdrawn in April 2023.
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