The National Medicines Safety Agency (ANSM) warns on Monday October 23 about vasoconstrictors, allowing to unclog the nose, while a representative of the pharmaceutical laboratories judges the opinion “premature”.
“In case of cold, avoid oral vasoconstrictor medications”advises the ANSM against communicated. She calls for not using Actifed Rhume, Humex, Rhinadvil, Nurofen Rhume or Dolirhume tablets, containing pseudoephedrine. “There are risks of adverse effects, rare, but very very serious in all populations even without risk factors and with limited uses”insists Christelle Ratignier-Carbonneil, the director of the organization at the microphone of Franceinfo.
The use of these medicines may cause “heart attacks and strokes”, warns the National Medicines Safety Agency (ANSM). For the director “there are non-drug alternatives”believing that for a blocked nose, one must avoid exposing oneself to “very serious side effects”. In particular, it recommends“moisten the inside of the nose with suitable washing solutions: physiological serum, thermal water or sea water sprays” or even “drink enough”.
The College of General Medicine, the National Professional ENT Council, as well as the National Order of Pharmacists and community pharmacists’ unions joined in this opinion, not to use oral forms of vasoconstrictor drugs.
A “premature” opinion, according to pharmaceutical laboratories
NèreS, representative of pharmaceutical laboratories, judges, for his part, “the benefit/risk ratio of these drugs is still favorable”considering the ANSM warning “premature”.
NèreS argues that “At this stage, the number of pharmacovigilance cases does not seem to have changed.” According to his data for “a total of 1.16 billion boxes dispensed”in sixteen years, “18 cases of PRES [syndrome d’encéphalopathie postérieure réversible] or RCVS [syndrome de vasoconstriction cérébrale pouvant provoquer des AVC] were noted »it is explained.
“According to a report presented to the experts of the pharmacovigilance risk assessment committee, among the 18 cases identified, two can be directly associated with the molecule. For the other 16, there are other confounding factors that can cause or favor PRES or RCVS”, adds NèreS.
In February 2023, the ANSM had requested reassessment vasoconstrictors on a European scale on the basis of new data, the details of which have not been specified. The European Union’s conclusions have not yet been issued and the sale of the above-mentioned medicines remains authorized.
The opinion of the European Union will decide on their availability on the market and whether it should be maintained, modified, suspended or withdrawn, throughout the European Union. These medications are available in many countries without a prescription.