“In view of the numerous contraindications, precautions for use and known adverse effects of pseudoephedrine and the benign nature of the common cold”, the National Medicines Safety Agency (ANSM) considers that “the possibility of obtaining these drugs without medical advice poses too great a risk to patients”, according to a decision unveiled on 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.
Considered dangerous for years
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.
Why not ban them sooner?
Why not have these drugs been banned 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.
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