Starting this Wednesday, French people who want to buy a medicine with pseudoephedrine, a decongestant to combat cold symptoms, at the pharmacy will only be able to purchase it with a doctor’s prescription. The French medicines agency has decided to tighten access to these drugs due to the appearance of rare but serious side effects that have been identified associated with their consumption. These include an increased risk of suffering a heart attack or stroke, as well as cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (CRVS).
In Spain, some of the products with pseudoephedrine that are marketed are, among others: ‘Gelocatil Gripe with pseudoephedrine’, ‘Frenadol decongestive 16 capsules’, ‘Cinfatós decongestivo’, ‘Reactine cetirizina pseudoephedrine’, ‘Actifed’, ‘Aerinaze’, ‘Aspirin’ Complex’, ‘Clarinase’, ‘Humex rhume’ and ‘Nurofen Cold and Flu’.
Last year, the European Medicines Agency evaluated hundreds of cold medicines with this compound and finally decided to avoid its use in patients with severe hypertension, kidney disease and kidney failure. In addition to asking health professionals to warn their patients to stop treatment immediately if after use they suffer from sudden severe headache, nausea or vomiting, symptoms of encephalopathy and cerebral vasoconstriction syndrome.
France, like all European states, including Spain, launched these recommendations. The French health authorities even banned direct-to-consumer advertising of cold medicines. These measures only achieved a temporary decrease in laboratory sales. “We are witnessing a new increase in sales from September 2024,” says the company. National Agency for the Safety of Medicines and Health Products of France (ANSM). Hence the tightening of the measures and the prohibition of its sale without a medical prescription.
In a releasethe ANSM justifies its decision in the middle of the flu and cold season and states that the consumption of products with the anticongestant pseudoephedrine can have serious adverse effects even in people without risk factors or medical history.
French health authorities also believe that without a prescription cases of misuse increase, the maximum recommended duration of treatment and contraindications are not respected.
On the list of toxic substances
«Taking into account the large number of contraindications, precautions for use and known side effects of pseudoephedrine, as well as the benign nature of the common cold that heals spontaneously between 7 and 10 days, we consider that the possibility of obtaining these medicines without medical advice exposes patients at too high risk.
France’s decision places pseudoephedrine on the list of toxic substances. Consequently, from December 11, 2024, oral vasoconstrictor medications containing pseudoephedrine can only be obtained with a prescription, and their use will require prior systematic medical advice.
An information sheet aimed at raising patient awareness of the risks associated with the use of these medications will be made available to healthcare professionals to distribute to patients when these medications are prescribed or dispensed.
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