Starting Wednesday, French health authorities will make it mandatory to present a prescription at the pharmacy to receive eight famous cold treatments, widely considered dangerous.
“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 medications without advice doctor poses too big.” a risk to patients,” according to a decision released Tuesday.
“We ask prescribing doctors to carefully evaluate the benefit/risk balance for each patient before prescribing one of these drugs,” added the ANSM, whose ban decision was expected.
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 all of these medications have in common is that they contain the pseudoephedrine molecule.
Its use is already discouraged
Widely considered dangerous for years, the main cold treatments were still over-the-counter. As winter approaches, French health authorities are considering finally putting an end to this paradox.
Available over the counter in tablet form, these treatments, which are also sold as a prescription nasal spray, aim to decongest and unclog the nose. Therefore, these are the main medications used against colds.
But for several years they have been the subject of numerous criticisms, starting from the ANSM itself, because they can cause serious side effects such as strokes and heart attacks.
In 2023, the agency explicitly recommended against using them for the first time. This decision had caused, for a time, a drop in sales of cold treatments. But these have recovered since September.
“The risk reduction measures we have implemented, such as the ban on advertising aimed at the general public, regular information on the dangers related to oral vasoconstrictors, as well as the provision of practical documents for patients and pharmacists, have not reduced enough the population is exposed to the risk of rare but serious adverse effects,” writes the ANSM.
A position shared by health professionals
Why haven’t these drugs been banned completely before? The French health authorities periodically explained that their hands were tied by European regulations that condition the withdrawal of an authorization to the opinion of the European Medicines Agency (EMA).
However, it estimated last year that the cold treatments in question did not present sufficient risks to ban them, even if they 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 finally decided, considering that the risk, even minimal, was unacceptable given the benign nature of the illness being treated: a simple cold.
This position coincides with that of the main French scientific societies (otolaryngologists, general practitioners, pharmacists) who oppose the use of these medications.
“Caregivers have better things to do”
On the other hand, there is a risk of offending pharmacists, many of whose representatives believe that such a restriction unfairly reduces the range of medicines they must offer their clients for colds, in a context marked by recurrent difficulties in obtaining medical appointments. .
“It will be difficult for us to respond to patients’ problems. People will no longer have a doctor and we will no longer be able to advise anything,” said Béatrice Clairaz-Mahiou, co-president of the French-speaking Society of Pharmaceutical Medicinal Sciences. (SFSPO).
But, for other observers, the health authorities, on the contrary, have already taken too long to react.
“Caregivers have better things to do than spend time advising patients against a drug that should be withdrawn from the market,” the independent magazine Prescrire estimated at the beginning of the year.
Source: BFM TV
