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Alert in France for cold drugs with pseudoephedrine

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Alert in France for cold drugs with pseudoephedrine

‘Stuffy’ nose, watery eyes, headache. With the arrival of the cold season, many people, to combat nasal congestion caused by colds, flu or allergies, without consulting a doctor, take very common drugs containing pseudoephedrine, a molecule that can expose one to the risk of myocardial infarctions and strokes. “.

No to DIY

The French National Agency for the Safety of Medicines and Health Products (ANSM) has warned against ‘do it yourself’ in taking these medicines and has once again recommended caution this year at the beginning of the season. Last February, at the request of the ANSM, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started an evaluation of the safety of these products, which are available within the EU. under various trade names, including Actifed*, Aerinaze*, Aspirin Complex* Clarinase*, Humex rhume* and Nurofen Cold and Flu*.

The cases

The Ansm statement, which was spread all over the French press, explains how “cases of posterior reversible encephalopathy syndromes (Pres) and reversible cerebral vasoconstriction syndromes (Rcvs) have been reported after taking an oral vasoconstrictor containing pseudoephedrine” , which can result in reduced blood flow (ischemia) to the brain and, in some cases, cause serious and life-threatening complications. But it is specified that “this is certainly a rare risk: 307 serious cases between 2012 and 2018”.

In France, authorities have been trying to limit the use of these drugs for several years, with the result that sales have plummeted. In 2018, advertising was banned and “other restrictive measures may be taken to protect patients”, the note reads.

The recommendations

The Anms therefore reminds us that “the common cold normally heals in less than 10 days without any help. But if the symptoms are ‘unbearable’ for the patient, it is advisable to use nasal washing solutions, such as saline or water sprays sea, drink a lot, sleep with your head raised and observe a suitable diet”.

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Last year the agency had already recommended that patients who want to take these drugs inform their pharmacist, so that he can advise them or not, to respect the dosage and not to exceed 5 days of treatment. Furthermore, vasoconstrictors should absolutely not be used in children under 15 years of age or during pregnancy or breastfeeding. And again, the last warning from the Anms: “Pay close attention to the symptoms that may indicate the onset of a myocardial infarction or cerebral ischemia”, they recommend, still urging “prudence” which “is the best guarantee of safety “.

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