Categories: HEALTH

Popular nasal congestion drug suspected of carrying serious risks

Stuffy nose. One of the most annoying effects of the common cold, flu, or certain allergies is difficulty breathing and a bad night’s rest, as well as excess mucus that can cause pain and coughing if it travels down the throat. In principle, these symptoms can be easily relieved by dozens of drugs, available in pharmacies with or without prescription, containing pseudoephedrine, a nasal decongestant that has been reviewed by the authorities due to the risk of cardiovascular accidents.

France’s medicines regulator has launched a campaign to advise against the use of some popular cold vasoconstrictor drugs due to their risk of heart attacks and strokes. “The risk is very small, but these events may occur regardless of the dose and duration of treatment,” the organization said.

Spanish pharmacies have 31 medicines, with or without a prescription, containing the controversial substance

Meanwhile, the European Medicines Agency (EMA) has been reviewing since February medicines containing pseudoephedrine, a highly potent vasoconstrictor that can cause narrowing of blood vessels in the nasal passages, reducing blood flow and thus causing nasal congestion. Facilitates the passage of air. breathe.

Spanish pharmacies supply 31 medicines that are under investigation by the EMA, some of which are widely used and appear in advertisements, such as Iniston Mucus and Congestion, Frenadol Decongestive, Gelocatil Gripe with Pseudoephedrine, Vincigrip… who at some point did not resort to Have these drugs pseudoephedrine helped? “This is the problem with over-the-counter medicines: they are widely used, but we cannot ignore the fact that they have side effects,” explains Santi Grau, director of the medical field at Barcelona’s Del Mar Hospital.

According to health ministry sources, there is no reason to panic. The risks of medicines containing pseudoephedrine are known and are described in the Summary of Product Characteristics for professionals and the package insert for patients. Ischemic cardiovascular and cerebrovascular events “occur with very low frequency”, which is why “the benefit/risk balance of these drugs remains favorable to date,” they said.

They are prescription and over-the-counter medications.

Harvey Yurio

Joan Martí-Fàbregas, head of the Stroke Department at Sant Pau Hospital, believes that the isolated cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) registered in France represent only “anecdotal situations”. . In his opinion, there are no conclusive studies on the alleged risk: “In real life, millions of people taking these drugs do not suffer strokes. There is a small risk that is questionable and anecdotal, and if it exists, It will affect people who abuse it more.”

Precisely, abuse is one of the big problems with pseudoephedrine, and exceeding recommended doses increases the likelihood of causing harm. “If you use it in large amounts, you typically get a tolerance effect and you need more doses to have the same effect. And the frequency of dosing increases, especially through the nasal route. People are very fascinated,” Dr. Grau explained. He warned that caution must be taken when treating children and people with cardiovascular problems, reduced kidney function, or changes in liver function: “They may accumulate more of the drug and be more sensitive to adverse effects.”

spanish pharmaceutical association

They advise pharmacists and users to exercise caution

In a document published yesterday, the Spanish Society of Clinical, Family and Community Pharmacy (Sefac) recommended the “responsible use of medicines containing pseudoephedrine and consultation with a pharmacist”, although it noted that most of these medicines have been used for more than five years , marketed in Spain, without any reports similar to the cases registered in France. However, given the current expected increase in the prevalence of influenza, colds and rhinitis, as well as an increase in the number of patients with contraindications, Sefac advises community pharmacists to take extra care when dispensing medicines containing pseudoephedrine. In this sense, it requires professionals to inform that the maximum dose is 120 mg every 12 hours, which should exclude children under 12 years of age, pregnant or breastfeeding women, patients with hypertension, hyperthyroidism or coronary heart disease, etc. “Discontinue treatment and seek medical advice if you develop high fever, dizziness, insomnia or nervousness, tachycardia or palpitations, nausea, vomiting, or persistent abdominal pain.”

To avoid repeated exposure and addiction issues, Grau is not optimistic that the drug may be repurposed and must be distributed under medical prescription controls. In this sense, the health department explains that new recommendations for use can be implemented based on the evidence being studied, “to avoid as far as possible potential social alarms arising from erroneous interpretations extracted from the initial information before the assessment of all data.” ” The ministerial source added: “This analysis is currently being completed (by the EMA) and the necessary harmonization measures will be taken at European level. “

Experts emphasize that pseudoephedrine relief is only a symptom and does not solve the underlying problem, which is usually a viral infection that will resolve itself within seven to ten days. Humidifying the inside of the nose with a saline solution or seawater spray, drinking plenty of fluids, sleeping with your head elevated, maintaining a cool environment (between 18 and 20°C), and regularly ventilating the room are all alternatives to medications that promote nasal congestion relief .

Monitored by EMA