Starting December 11, 2024, the sale of eight cold treatments will be restricted in France. In order to combat inappropriate or even dangerous uses of these drugs, the ANSM has decided to tighten the rules for obtaining them.
In order to reduce the risks, the National Agency for the Safety of Medicines, or ANSM, has decided to restrict certain cold medications. These treatments, used too commonly and without sufficient precautions, will now only be available on medical advice.
Which drugs are concerned?
In a press release published this Tuesday, the Ansm specifies that its decision concerns oral vasoconstrictors based on pseudoephedrine. That is to say that they promote the nasal decongestion.
200% Deposit Bonus up to €3,000 180% First Deposit Bonus up to $20,000The following are concerned: Actifed Rhume, Actifed Rhume day and night, Dolirhume Paracetamol and Pseudoephedrine, Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine, Humex Rhume, Nurofen Rhume, Rhinadvil Rhume, Ibuprofen/Pseudoephedrine, Rhinadvilcaps Rhume Ibuprofen/Pseudoephedrine.
A molecule criticized
"We have decided to classify pseudoephedrine on list I of substances poisonous”, the Ansm has just announced. This substance has been criticized for several years. The health agency pointed out as early as last winter that serious adverse effects weighed too heavily on the benefit/risk balance. This molecule, which aims to get rid of the common cold – a generally benign, although uncomfortable, illness – represents significant risks: encephalopathy, myocardial infarction, stroke … regardless of the history.
Under what conditions ?
These drugs have not disappeared for all that. Only, they will no longer be available over the counter. It will therefore be necessary, as with many treatments, to contact your doctor who will assess its relevance and will, or will not, issue a prescription.
And the health agency insists: “We ask prescribing doctors to carefully assess the benefit/risk balance for each patient before prescribing one of these drugs.”
The Ansm had already implemented certain measures, without seeing any improvement: “The risk reduction measures that we have implemented, such as the ban on advertising to the general public, regular information on the dangers associated with oral vasoconstrictors, as well as the provision of practical documents for patients and pharmacists, have not not sufficiently reduced the population exposed to the risk of occurrence of rare but serious adverse effects.”
These new restrictions will take effect from Wednesday, December 11, when pharmacies open.