French health authorities are making it compulsory from Wednesday to present a prescription at a pharmacy to receive eight famous anti-cold treatments widely considered dangerous. “In view of the numerous contraindications, precautions for use and known adverse effects of pseudoephedrine on the one hand and the benign nature of the common cold on the other hand,” the National Medicines Safety Agency (ANSM) considers that “the possibility of obtaining these medicines without medical advice poses too great a risk to patients”, according to a decision revealed Tuesday.
“We ask prescribing doctors to carefully assess the benefit/risk balance for each patient before prescribing one of these medications,” added the ANSM, whose ban decision was awaited.
This includes 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. What these drugs all have in common is that they contain the pseudoephedrine molecule.
Use not recommended since 2023
Widely considered dangerous for years, the main cold treatments were still over-the-counter. As winter approached, French health authorities were considering finally putting an end to this paradox.
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 therefore the main medications used against colds.
But they have been the subject of numerous criticisms for several years, starting with the ANSM itself, because they can cause serious side effects such as strokes and heart attacks. In 2023, the agency had for the first time explicitly recommended against their use. This decision had, for a time, caused sales of anti-cold treatments to decline. But these have rebounded since September.
“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 rare but serious adverse reactions. writes the ANSM.
Serious but very rare side effects
Why not have these drugs been banned altogether earlier? The French health authorities regularly explained that their hands were tied by European regulations which make the withdrawal of an authorization subject to the opinion of the European Medicines Agency (EMA). However, it estimated last year that the anti-cold treatments concerned did not present sufficient risks to ban them, even if it imposed new contraindications.
This opinion is explained by the fact that serious side effects remain very rare. A few are reported each year and, in France, no deaths have been reported. However, the French authorities ultimately decided, considering that the risk, even low, was unacceptable given the benign nature of the illness being treated: a simple cold.
This position is in line with the main French learned societies – ENT specialists, general practitioners, pharmacists – who all oppose the use of these drugs.
On the other hand, it risks offending pharmacists, many of whose representatives believe that such a restriction unfairly reduces the range of medications to be offered to their customers with colds, in a context marked by recurring difficulty in obtaining medical appointments.
“It will become complicated for us to respond to patients’ problems. People will no longer have a doctor and we will no longer be able to advise anything.” estimated in the Pharmacist’s Daily Béatrice Clairaz-Mahiou, co-president of the French-speaking Society of Pharmacy Sciences (SFSPO).
But, for other observers, the health authorities have, on the contrary, already been too slow to react.
