“Avoid oral vasoconstrictor drugs if you have a cold!” This is the advice given by the French Medicines Agency on its website, warning that people who consume the drug may develop reversible posterior encephalopathy syndrome and reversible cerebral vasoconstriction syndrome cases. Medications containing pseudoephedrineIt is a commonly used medicine to treat nasal congestion during colds, flu, or rhinitis. In February, the European Medicines Agency (EMA) launched a review of the drugs at the request of French and Spanish regulators. Spanish Society of Clinical, Family and Community Pharmacy (SEFAC) Pharmacists are advised to use extreme caution and responsibly.
Pseudoephedrine acts as an agonist at alpha-1 adrenergic receptors, causing vascular stenosis nostril, which reduces local blood flow and results in the desired relief of nasal congestion. On the market, it can be found in the form of tablets, powder sachets dissolved in water or syrup.
Available medications Spain Pseudoephedrine medications include prescription and other over-the-counter medications. Prescription-free pseudoephedrine medicines are available in varying amounts from 6 mg to 240 mg and can be dispensed by community pharmacists for the relief of symptoms of congestion, runny nose and sinus congestion associated with the common cold, flu and in adults and Allergic rhinitis in children over 6 years of age.
Although there are no reported cases in Spain similar to those recorded in France, its adverse effects are known, such as nervousness, irritability, insomnia or taste disorders. Additionally, it is contraindicated in patients with medical conditions such as heart disease, hyperthyroidism, or glaucoma.In fact, pseudoephedrine has a known risk for ischemic cardiovascular and cerebrovascular events, including Stroke and myocardial infarction.
under the spotlight
this National Agency for the Safety of Medicines and Health Products (ANSM) Putting drugs containing pseudoephedrine in the spotlight. According to the French regulatory agency, “myocardial infarction and stroke may occur after the use of vasoconstrictor drugs (pseudoephedrine) to relieve cold symptoms.” Regardless, ANSM suggests, Risk ‘very low’But given the severity of the events, the persistence of cases and the fact that these events can occur “regardless of dose and duration of treatment,” it is recommended not to use the drug and to increase monitoring. In addition, other restrictive measures are being considered to protect patients.
safety committee European Medicines Agency (EMA)For its part, it launched a review process in February 2023 to assess possible measures aimed at restricting the use of these products, but has yet to comment on the matter. Common drugs such as Gelocati Gripe with Pseudoephedrine, Frenadol Decongestive or Cinfatós Complex are being monitored.
SEFAC recommendations
In Spain, medicines containing pseudoephedrine have been on the market for more than five years without any reports similar to the cases registered in France.However, SEFAC recommends that community pharmacists extreme caution When dispensing medicines containing pseudoephedrine, “taking into account the current expected increase in the prevalence of these symptoms, the severity of the cases that have occurred, and the large number of patients with contraindications and precautions for pseudoephedrine in routine pharmaceutical practice.”
Likewise, to ensure patient safety, pharmacists are advised to provide patients with the following advice: Correct dosage and risk of overdose. In this sense, the maximum limit for taking pseudoephedrine is 120 mg every 12 hours, but children under 12 years of age, pregnant and lactating women should be excluded.
SEFAC also requires verification of its contraindications in patients with: Hypertension, hyperthyroidism, coronary heart disease and those receiving monoamine oxidase inhibitors.Likewise, it insists on its use in patients with Glaucoma, Prostatic Hypertrophy and Diabetes, as they can exacerbate these conditions. It is also not recommended for use in elderly patients or during heat waves.
Finally, patients are reminded to stop treatment and seek medical advice if they develop high fever, dizziness, insomnia or nervousness, tachycardia or palpitations, nausea, vomiting, or persistent abdominal pain.