Over-the-counter cold medications can cause myocardial infarctions and strokes. This is a “rare” but very serious risk, as the French National Agency for the Safety of Medicines and Healthcare Products (ANSM) claims. The announcement comes with the start of cold and flu season. A number of medications are available to relieve nasal congestion, usually available without a prescription. In France, the most common names are Actifed, Dolirhume, Nurofen Rhume, Humex or Rhinadvil. These are vasoconstrictor drugs used to relieve nasal congestion, and three million boxes of them have been sold at Hexagon alone. “Myocardial infarction and stroke may occur following the use of vasoconstrictor medications (pseudoephedrine) to relieve cold symptoms,” the agency said in a press release issued Oct. 23. “The risk is very low, but these events can occur regardless of the dose and duration of treatment. Although the consequences associated with these drugs are rare, the French institution still considers the risk to be too high for a simple nasal congestion.” The escalation of these events and the persistence of cases (despite precautions already implemented), combined with the non-essential nature of vasoconstrictors, leads the ANSM to recommend against their use,” the press release states.
Total ban request
The warning is merely a recommendation, but as recently as February the agency asked the European Union to conduct an assessment of the risks associated with such drugs, based on new data from recent studies. “Recent data from pharmacovigilance databases and medical literature report cases of posterior reversible encephalopathy syndromes (PRES) and reversible cerebral vasoconstriction syndromes (RCVS) after receiving an oral vasoconstrictor containing pseudoephedrine,” ANSM writes in the press release. The hypothesis put forward by the agency is for a real ban on these products. The analysis was entrusted to the Pharmacovigilance Risk Assessment Committee (Prac), whose final report on the safe use of drugs containing pseudoephedrine is expected by the end of 2023. Although the final evaluation is still awaited, the position of the transalpine institution is rather mixed. harsh and at the same time advises all citizens against the use of these drugs.
Opposition from pharmaceutical companies
NèreS, the agency representing pharmaceutical companies in the Alps, has a completely different view. “As a reminder, in the last 16 years, 18 cases of PRES or RCVS following administration of a pseudoephedrine-containing product have been reported across Europe, with a total of 1.16 billion packs distributed,” the pharmaceutical companies write in a statement. “Also, according to a report submitted to Pra experts, two of the 18 recorded cases can be directly attributed to the compound. In the other 16, there are other confounding factors that may have caused the diseases studied,” adds Nères, noting that “the risk/benefit ratio of these drugs is still positive.” However, the drug safety agency remains convinced that the potential harm is not sufficient to justify the use of these medicines. “There are rare but very, very serious risks of undesirable effects in all populations, even in the absence of risk factors and with limited use,” ANSM director Christelle Ratignier-Carbonneil told Franceinfo. Alternatively, to relieve nasal congestion, the director recommends “moisten the inside of the nose with appropriate cleansing solutions: saline solution, thermal water, or seawater spray.” Another helpful tip: “drink enough water”.
Source: Today IT
Karen Clayton is a seasoned journalist and author at The Nation Update, with a focus on world news and current events. She has a background in international relations, which gives her a deep understanding of the political, economic and social factors that shape the global landscape. She writes about a wide range of topics, including conflicts, political upheavals, and economic trends, as well as humanitarian crisis and human rights issues.
