Myocardial Infarctions and Strokes Linked to Over-the-Counter Cold Medicines, French Agency Warns
A recent announcement by the French National Agency for the Safety of Medicines and Health Products (ANSM) has unveiled a potential risk associated with over-the-counter cold medicines – they may lead to myocardial infarctions and strokes. While the risk is rare, it is still considered very serious and has prompted calls for a total ban on these medications.
As the cold and flu season starts, many people rely on over-the-counter cold medicines to relieve symptoms such as a stuffy nose. In France, popular brands like Actifed, Dolirhume, Nurofen Rhume, Humex, or Rhinadvil are commonly used to alleviate nasal congestion. These medications contain vasoconstrictor drugs that help unblock the nose. Shockingly, in France alone, three million boxes of these drugs have been sold.
The ANSM stated in a press release published on October 23 that “Myocardial infarctions and strokes may occur after the use of vasoconstrictor drugs (pseudoephedrine) to relieve cold symptoms.” The agency also emphasized that the risk persists regardless of the dosage and duration of treatment. Although the adverse effects associated with these drugs are rare, the ANSM believes that the risk is too high to justify their use for a mere stuffy nose.
The severity and persistence of cases related to these medications, despite previous actions taken, have prompted the ANSM to strongly advise against their use. The agency demands a complete ban on these products. In February, the ANSM requested the European Union to assess the risks of these drugs based on emerging data from recent studies. The agency highlighted the emergence of cases involving posterior reversible encephalopathy syndromes (PRES) and reversible cerebral vasoconstriction syndromes (RCVS) after the consumption of oral vasoconstrictors containing pseudoephedrine. The final report on the safe use of drugs containing pseudoephedrine is anticipated by the end of 2023.
Notably, pharmaceutical companies represented by NèreS have voiced opposition to the ANSM’s concerns. NèreS argues that only 18 cases of PRES or RCVS have been reported in Europe over the past 16 years, despite 1.16 billion packs of pseudoephedrine-containing products being dispensed. Additionally, a report presented to the Pra experts indicates that only two cases can be directly attributed to the compound, while other factors may have caused the remaining 16 cases. Based on this analysis, the pharmaceutical companies believe that the risk/benefit ratio of these drugs remains favorable.
However, the ANSM remains convinced that the potential harm outweighs the benefits and advises against the use of these drugs. Christelle Ratignier-Carbonneil, the director of the ANSM, emphasized the risks of serious adverse effects, even among populations without risk factors and with limited use. Instead of relying on vasoconstrictor drugs, the director suggests using suitable cleansing solutions to moisten the inside of the nose, such as saline solution, thermal water, or sea water spray. Staying hydrated is also recommended.
The debate around the safety of over-the-counter cold medicines is ongoing, with the ANSM advocating for a complete ban while pharmaceutical companies argue for their continued use. As the evaluation of the risks associated with these drugs progresses, it remains crucial for consumers to stay informed and consult healthcare professionals for the safest alternatives to alleviate cold symptoms.