Active Rume, Goodbye or even Humex Rhumeanti-cold medications are flooding the market and are still in free sale. However, they are widely considered to be dangerous for years. As winter approaches, French health authorities are considering finally putting an end to this paradox.
“The delivery of these medications without a medical prescription no longer appears appropriate“, estimated Thursday, in an email toAFPthe National Medicines Safety Agency (ANSM). She says she is considering “listage” of these treatments, a measure which would take effect immediately and would in fact result in them no longer being available over the counter in pharmacies.
These drugs all have in common that they contain the molecule pseudoephedrine. The main ones are called Active Rume,Goodbye, Humex Rhume, Nurofen Cold et Rhinadvil Rhume.
Available without a prescription in tablet form, these treatments — also sold by spray nasal on prescription — aim to decongest and unclog the nose. These are therefore the main medications used against colds.
Serious side effects like strokes and heart attacks
But they have been the subject of numerous criticisms for several years, starting with the ANSM itself, because they can cause serious side effects like AVC and heart attack.
The measure envisaged by the medicines agency – relayed in recent weeks by specialized titles such as Pharmacist’s Daily — is, as such, the last episode in a long series which has seen him gradually harden his positions in the face of this family of treatments.
In 2023, it explicitly advised against their use for the first time. This decision had, for a time, caused sales of anti-cold treatments to decline. But these have been rebounding since September, a situation that the ANSM considers particularly worrying.ahead of the winter season” and its attendant illnesses.
Why not ban these drugs altogether? French health authorities regularly explain that their hands are tied by European regulationswhich subjects the withdrawal of an authorization to the opinion of the European Medicines Agency (EMA).
European and French authorities at odds
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.
The European and French authorities are therefore in disagreement, the latter considering that the risk, even low, is unacceptable given the benign nature of the illness being treated: a simple cold. “Too many patients remain exposed to serious risks compared to the modest benefits of these medications.“, judges the ANSM.
“It will become complicated for us to respond to patients’ problems”
This position is in line with the main French learned societies – ENT specialists, general practitioners – who all oppose the use of these drugs.
On the other hand, it risks offending the pharmacistsmany 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.“, believes, in the Pharmacist’s Daily, Béatrice Clairaz-Mahiouco-president of the French-speaking Society of Officinal Pharmaceutical Sciences (SFSPO).
Health authorities who are slow to act?
But, for other observers, the health authorities have, on the contrary, already been too slow to react.
“Healthcare providers have better things to do than spend time advising patients against a drug that should be withdrawn from the market“, estimated at the beginning of the year the independent review Prescribeseeing in the European decision a “missed opportunity (to) protect patients“.
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