These are medications widely consumed by the French to unclog the nose, but considered dangerous for health. From this Wednesday, “a prescription must be presented” to obtain eight vasoconstrictor drugs so-called “anti-colds”, we learned this Monday evening franceinfo who had access to the recommendations of the National Medicines Safety Agency (ANSM). “Prior and systematic medical advice” will be necessary, adds the ANSM. At the end of November, she had already indicated that she was considering removing these treatments from over-the-counter sales.
The ANSM wishes to limit “patient exposure to rare but serious risks associated with these medications” such as myocardial infarction and stroke. “It’s a shame to run the risk of having a stroke or a heart attack over a simple cold,” estimated at the end of November on franceinfo the doctor Jean-Paul Hamon, general practitioner and honorary president of the Federation of Doctors of France (FMF).
The medicines concerned are: Actifed Cold, Actifed Cold day and night, Dolirhume Paracetamol and Pseudoephedrine, Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine, Humex Cold, Nurofen Cold, Rhinadvil Cold Ibuprofen/Pseudoephedrine and Rhinadvilcaps Cold Ibuprofen/ Pseudoephedrine.
New neurological risks
According to the ANSM, “new neurological risks have been confirmed by the European Medicines Agency (EMA)”adding to the already known risks. “These adverse effects can appear in patients without risk factors or medical history, regardless of the dose and duration of treatment”also alerts the Medicines Agency. She also emphasizes cases of misuse. As these medications are over the counter, “the maximum recommended treatment duration and contraindications are not always respected”by patients. Thus, the ANSM considers “that the possibility of obtaining these medicines without medical advice poses too great a risk to patients”. Furthermore, the Agency calls on general practitioners to exercise the greatest caution and asks them “to carefully assess the benefit/risk balance for each patient before prescribing one of these medications”.
“We are taking this measure to protect patients“, declared this Tuesday, on franceinfo, Alexandre de La Volpilière, deputy director general of the ANSM
The institution tried to limit the sales of these vasoconstrictors, by banning all advertising in 2018 or by increasing recommendations to professionals. At the end of last yearthe ANSM for the first time officially recommended against the use of these drugs, which led to a temporary drop in consumption, reports franceinfo. However, since last September, the Medicines Safety Agency has noted “a further increase in laboratory sales”which motivates this new recommendation.
Why are these treatments not prohibited?
Why not ban these drugs altogether? The French health authorities regularly explain that their hands are tied by European regulations, which make the withdrawal of an authorization subject to the opinion of the European Medicines Agency. However, the EMA 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 consider 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 drugs”judges the ANSM.
