This article was automatically translated from HIBAPRESS, the Arabic version:
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Hibapress
Anti-cold medications will be banned from over-the-counter sales from Wednesday in France, according to the National Medicines Safety Agency (ANSM), which makes it mandatory to present a prescription to acquire these pseudoephedrine-based treatments which can cause side effects. serious, such as the risk of heart attack or stroke.
“The ANSM is changing the conditions for dispensing oral vasoconstrictors containing pseudoephedrine used to relieve cold symptoms. From December 11, 2024, a prescription must be presented to obtain these medications in pharmacies,” indicated the French medicines watchdog in a press release.
In total, eight medicines are affected by this measure, namely: Actifed Cold, Actifed Cold day and night, Dolirhume Paracetamol and Pseudoephedrine, Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine, Humex Cold, Nurofen Cold, Rhinadvil Cold Ibuprofen/Pseudoephedrine, Rhinadvilcaps Cold Ibuprofen/Pseudoephedrine.
“In view of the numerous contraindications, precautions for use and known adverse effects of pseudoephedrine, and the benign nature of the common cold (disease which heals spontaneously in 7 to 10 days), we consider that the possibility of obtaining these medications without medical advice poses too great a risk to patients,” explains the ANSM.
The new measure is, according to the agency, a continuation of actions undertaken for several years to “limit the exposure of patients to the rare but serious risks associated with these medications (notably myocardial infarction and stroke)”.
Last winter, the ANSM recommended against the use of oral vasoconstrictors based on pseudoephedrine to relieve cold symptoms (nasal decongestant), which led, according to the agency, to a temporary drop in sales without major impact on patient exposure, before noting “a further increase in laboratory sales since September 2024”.
“The risk reduction measures that we have put in place, such as the ban on advertising to the general public, regular information on the dangers linked to oral vasoconstrictors, as well as the provision of practical documents for patients and pharmacists, have not sufficiently reduced the population exposed to the risk of occurrence of rare but serious adverse effects,” notes the press release.
The ANSM cites new neurological risks confirmed by the European Medicines Agency (EMA) with medicines containing pseudoephedrine (posterior reversible encephalopathy syndromes and reversible cerebral vasoconstriction syndromes), which are added to the numerous risks already known, including stroke and myocardial infarction.
In France, nasal forms of vasoconstrictors have already been subject to medical prescription for many years, in particular because of their neurological and cardiovascular adverse effects, recalls the same source which estimates that adverse effects can appear in patients without risk factors or medical history, regardless of the dose and duration of treatment.
