They are once again implicated. Anti-cold medications, popular with the arrival of winter, have long been considered dangerous by health authorities. However, they are still currently available over the counter on pharmacy shelves. And there are still numerous products available on the market: Actifed Rhume, Dolirhume, Humex Rhume, Nurofen Rhume, Rhinadvil Rhume… But that could soon change. After two alerts in 2021 and then in 2023, the National Medicines Safety Agency (ANSM) says it is considering “listing” these treatments. In other words: it could decide to place anti-cold products on the list of treatments only available on medical prescription.
Repeated warnings
“The delivery of these medications without a medical prescription no longer appears appropriate,” explained the medicine policeman on Thursday, November 21, in an email sent to Agence France Presse. Concretely, this “listing” would constitute a measure with immediate effect and would result, as soon as it was implemented, in prohibiting the over-the-counter sale of anti-cold medications in pharmacies. “In France, medicines are classified on different lists depending on their prescription and delivery conditions,” recalls the ANSM on its website. List 1 compiles all the products that can only be delivered for a given time by a prescription, while those placed on list 2 can be obtained several times during a year from the same prescription, “unless otherwise indicated by the prescriber” .
For the moment still available without a prescription in the form of tablets, these treatments – also sold by nasal spray on prescription – aim to decongest and unclog the nose. These are the main medications used for colds. But they are singled out for their risks of side effects, such as strokes and heart attacks. Last year, she explicitly asked not to use these products, causing the number of sales of the product to decrease for a while. But in recent weeks, with the return of winter and its viruses, purchases of such medications have rebounded.
Conflict between French and European agencies
Couldn’t a ban on the sale of these drugs have already been imposed by now? The ANSM explains that European regulations prevent it from doing so for the moment. The European Medicines Agency (EMA) must in fact validate the withdrawal of a medicine decided by the French body. However, the EU structure estimated last year that the anti-cold treatments concerned did not present sufficient risks to prohibit them definitively, although it imposed new contraindications on their use. The justification for this decision? Cases of side effects, although they can be very serious when they occur, remain extremely rare.
The ANSM, for its part, does not budge: people who are treating themselves for a mild illness, the common cold, should not run such a serious risk. “Too many patients remain exposed to serious risks compared to the modest benefits of these medications,” says the public health agency. The main French learned societies, such as those of ENTs and general practitioners, are also opposed to the use of these drugs.