Medicines that can be bought without a prescription to treat blocked noses pose a rare but very serious risk to users, the French National Agency for the Safety of Medicines and Health Products (ANSM) said on Monday as cold and flu season gets underway.
The medicines referred to in the agency’s warning are so-called vasoconstrictor drugs used to unblock the nose, with those most popular being Actifed, Dolirhume, Nurofen Rhume, Humex or Rhinadvil. Last year, three million boxes were sold in France.
“Myocardial infarctions and strokes can occur after using vasoconstrictor drugs (pseudoephedrine) to relieve cold symptoms”, the agency said in the press release published on Monday.
“There are risks of undesirable effects, rare but very, very serious, on all populations, even those without risk factors and with limited use”, Christelle Ratignier-Carbonneil, the medicine agency’s director, told Franceinfo on Monday.
Even though strokes and heart attacks linked to these specific drugs remain rare, the French agency believes the risk to be too great for a mere blocked nose.
But because the agency can only advise citizens not to use them, as only the European Union can order their withdrawal from the market or ban them outright, the French agency requested an EU-level evaluation in February to reassess the drug’s risks based on new data.
While the EU has not yet reacted to the French request, an EU-wide ban would need EU health agencies to agree with the French agency.
In the meantime, the French agency’s director recommends “moistening the inside of the nose with appropriate cleansing solutions: saline solution, thermal water or seawater sprays” and “drinking enough water”.
But the agency’s warning is “premature”, said NèreS, the French association representing pharmaceutical companies, adding that “the benefit-risk ratio of these drugs is still favourable”.
(Clara Bauer-Babef | Euractiv.fr)
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