Get out your tissues: eight famous cold treatments are no longer available over the counter. Considered dangerous, the French health authorities are making it compulsory from this Wednesday to present a prescription at a pharmacy to receive them.
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.
The benefit/risk balance
“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 Monday.
Available in tablet form, these treatments – also sold by prescription nasal spray – aim to decongest and unclog the nose. 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 explicitly advised against their use for the first time. This decision had, for a time, caused sales to decline. But these have rebounded since September.
No deaths in France
So 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 these treatments 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 eventually 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, general practitioners, pharmacists) who all oppose the use of these medications.
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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.