by Health Editorial Staff
Aifa notes after the reports regarding posterior encephalopathy syndrome and cerebral vasoconstriction syndrome. «It is not a cure for colds, but only blocks the symptoms»
Medicines containing pseudoephedrine, an active ingredient effective against nasal congestion, must not be used in patients with severe or uncontrolled high blood pressure (untreated or resistant to therapy) or with severe or chronic acute renal disease or failure. The Italian Medicines Agency (AIFA) reiterated this in an online note after the European Medicines Agency (EMA) had confirmed the restrictions on the use of medicines containing pseudoephedrine in December. Pseudoephedrine is an active ingredient often used in cases of colds or allergies. In February the PRAC started a review of the safety of the products, after some cases described by the French Medicines Agency. The reports concerned posterior encephalopathy syndrome (Pres) and cerebral vasoconstriction syndrome (Rcvs), both reversible, which occurred in people who had used the drug.
I symptoms of Pres and Rcvs
«These are rare conditions, which however can lead to a reduced blood supply to the brain, potentially causing serious and life-threatening complications – the EMA points out -. With timely diagnosis and treatment, symptoms of PRES and RCVS usually resolve. Available evidence has demonstrated that pseudoephedrine is associated with risks of Pres and Rcvs and this information will be indicated on the products.
The Aifa note
«Some cases of posterior reversible encephalopathy syndrome (Pres) and reversible cerebral vasoconstriction syndrome (Rcvs) have been reported with the use of medicines containing pseudoephedrine. Such medicines are contraindicated in patients with severe or uncontrolled hypertension, or with acute or chronic renal disease or renal failure, as these conditions increase the risks of Pres or Rcvs.” Thus the Italian drug agency Aifa.
Healthcare professionals should advise patients to immediately stop using pseudoephedrine-containing medicines and undergo specific therapy if they develop symptoms of PRES or RCVS, such as severe headache with sudden onset, feeling sick, vomiting, confusion, seizures, and discomfort. visual”.
It is not a cure for colds
«Drugs containing pseudoephedrine can only be useful against colds in a few cases – commented the general secretary of the Federation of general practitioners (Fimmg), Silvestro Scotti -. In general they prolong its duration, the symptom is simply blocked but then returns. And prolonged use is not beneficial. The drug can be used in selected situations: for example for a person who cannot sleep due to a stuffy nose and has a commitment that cannot be postponed the next day. In this case you can take advantage of it. But it is a mistake to think that it is a cure for a cold. To purchase the drug you do not need a prescription or a visit, but a consultation and advice is needed, particularly for patients with risk factors and if you tend to continue using it over time. Talking about it with your doctor is absolutely necessary.”
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December 12, 2023 (modified February 12, 2024 | 8:05 pm)
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