The National Agency for the Safety of Medicines and Health Products has warned of the risks associated with taking anti-cold tablets. The latter, documented for years, have not, however, led to the withdrawal of these drugs from the market. Explanations.
“There is no risk of stroke due to a blocked nose.” The director of the National Agency for the Safety of Medicines and Health Products (ANSM), Christelle Ratignier-Carbonneil, warned of the risk linked to taking anti-cold tablets, Monday October 23 on franceinfo. Humex, Dolirhume, Actifed, Nurofen, Rhinadvil… These tablets, which are available without a prescription, contain a substance called pseudoephedrine, which constricts the blood vessels, helping to decongest the sinuses. But undesirable effects, up to “of the myocardial infarction and stroke, can occur” after their ingestion, also warns the ANSM.
“The risk is very low, but these events can occur regardless of the dose and duration of treatment”, she adds. Since “LA cold heals spontaneously in seven to ten days.the ANSM therefore decided, for the first time, of “recommend against their use”. The College of General Medicine, the National Professional ENT Council, as well as the National Order of Pharmacists and community pharmacists’ unions have joined in this recommendation. Taking vasoconstrictors nasally, in spray form, is not affected, the latter being only issued by prescription.
Repeated alerts from the scientific community
This is not the first time that the scientific community has warned of the dangers of oral vasoconstrictors, which are very popular with the general public. Since 2006, the medical journal Prescribe believed that taking pseudoephedrine-based medications caused risks “disproportionate risks” to patients. The interest of the molecule is judged “weak”, “taking into account insufficiently established effectiveness and the cardiovascular risk“, also wrote the High Authority of Health in 2012.
Between 2012 and 2017, data from the national pharmacovigilance database reported “40 cases of serious adverse effects with oral vasoconstrictors, including two deaths”, underlined the ANSM in 2017. The agency then noted that in more than a third (35%) of reports of serious adverse effects, the instructions on taking the medication were not followed (duration greater than five days , combination of several vasoconstrictors, age less than 15 years, etc.). And, in almost half (45%) of cases, patients suffering from these serious adverse effects “had at least one known cardiovascular risk factor”which should have contraindicated taking the medication.
A series of measures to reduce consumption
While the observation is shared by many scientific authorities, why are these drugs still authorized on the market? “Measures have been taken in recent years” to regulate the consumption of oral vasoconstrictors, reminds franceinfo Gilles Munier, vice-president of the national council of the Order of Physicians.
In 2017, the ANSM banned advertising (PDF document) for these medications. In 2019, then in 2022 and in 2023, it has “solicited all the stakeholders concerned (users, patients and health professionals, then industrialists) in order to initiate discussions on the measures to be put in place” with a view to limiting the consumption of these products, recalls the agency. In 2020, it published two practical sheets, one for pharmacists and the other for patients (PDF document)to remind you of the rules governing the taking of these medications.
EFinally, in February 2023, the French agency contacted the European Medicines Agency (EMA) so that it could reassess the benefit/risk ratio of oral vasoconstrictors, which could lead to a suspension or withdrawal. European markets. “As these drugs are available in many other European countries, the ANSM has requested their re-evaluation at the European level“, she explained. After the EMA’s opinion, it will be up to the European Commission to make a decision on whether or not to withdraw vasoconstrictors from the market, which will have the force of law for the Member States.
Laboratories denounce “premature communication”
The French agency’s communication efforts were not in vain, since the consumption of oral vasoconstrictors was halved, from 7.3 million boxes sold in the winter of 2016-2017 to 3 million in the winter. winter 2022-2023, according to her. But “the seriousness of these accidents and the persistence of cases”despite the drop in consumption, pushed it to take a step forward by purely and simply recommending against their use, without waiting for a European decision.
“The EU investigation is long, and its results will not be known for several months, or even several quarters.”, also justifies Gilles Munier. For the doctor, it was therefore important that the medical profession made a decision without delay, “as we enter the period where we encounter seasonal rhinitis”.
An assessment that NèreS, the professional association which represents pharmaceutical laboratories, does not share. In a press release (PDF document) published Monday, she denounces “a communication from the ANSM (…) premature and alarmist”, while the EMA evaluation is still ongoing. To combat the misuse of these medications, she reminds “the importance of a controlled dispensation” oral vasoconstrictors,by further valuing advice and the role of the pharmacist”. “In terms of safety, I believe that you can never go too fast”replied the president of the ANSM on BFMTV.