Mainstream cold treatments have been considered unsafe for years, but they are still available without a prescription. As winter approaches, French health authorities are considering finally putting an end to this paradox. “The delivery of these medicines without a prescription no longer seems appropriate,” the National Medicines Safety Agency (ANSM) stated in an email to AFP on Thursday, November 21.
It says it is considering listing these treatments, a move that would take effect immediately and would, in practice, result in them no longer being available over the counter in pharmacies.
What all of these medications have in common is that they contain the pseudoephedrine molecule. The main ones are called Actifed Rhume, Dolirhume, Humex Rhume, Nurofen Rhume and Rhinadvil Rhume. 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.
Use advised against by ANSM last year
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.
The measure planned by the drug agency – reported in recent weeks by specialized titles such as Le Quotidien du Pharmacien – is, therefore, the latest episode in a long series that has seen it progressively harden its positions regarding this family of deals.
In 2023 it explicitly discouraged its use for the first time. This decision had caused, for a time, a drop in sales of cold treatments. But these have been recovering since September, a situation that the ANSM considers especially worrying “in the face of the winter season” and its procession of diseases.
Why not ban these drugs completely? The French health authorities periodically explain that their hands are tied by European regulations, which 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.
A decision that will probably displease pharmacists
Therefore, the European and French authorities do not agree, the latter considering that the risk, even minimal, is unacceptable given the benign nature of the disease in question: a simple cold. “Too many patients remain exposed to serious risks compared to the modest benefits of these medications,” the ANSM believes.
This position is in line with the main French scientific societies, all of which oppose the use of these drugs. 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 Society, in the Quotidien du Pharmacist of Francophone Pharmaceutical 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, seeing in the European decision a “missed opportunity (to) protect patients.” .”
Source: BFM TV
