The Safety Committee of the European Medicines Agency (EMA) has initiated a review of medicines containing pseudoephedrine to investigate possible links with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Conditions affecting blood vessels in the brain.
France’s medicines regulator has launched a campaign advising people not to use a range of vasoconstrictor drugs to treat colds. risk of myocardial infarction and cerebrovascular accident, Meanwhile awaiting a ban from the European Union (EU). Specifically, these cold medicines contain pseudoephedrine, an active ingredient that the EMA is monitoring and found in well-known medicines such as the decongestant Frenadol or Gelocatil Flu.
Pseudoephedrine is taken by mouth, alone or with other medications, to treat nasal congestion (stuffy nose) caused by colds, flu, or allergies.
Some medicines containing pseudoephedrine are sold under various trade names, e.g. “Gelocatil Gripe with pseudoephedrine”, “Frenadol Decongestant 16 Capsules”, “Cinfatós Decongestant”, “Reactine cetirizina pseudoephedrine”, “Actifed”, “Aerinaze”, “Aspirin Complex”, “Clarinase”, “Humex rhume” and “Nurofen Cold” ‘and the flu’.
Pseudoephedrine works by stimulating the release of the chemical norepinephrine from nerve endings, which causes blood vessels to constrict (narrow). This reduces the amount of fluid released by the blood vessels, thereby reducing inflammation and mucus production in the nose.
Some EU member states approve medicines containing pseudoephedrine for use alone or in combination with medicines to treat cold and flu symptoms such as headache, fever and pain, or allergic rhinitis (inflammation of the nasal passages) in people with nasal congestion.
PRES and RCVS may cause reduced blood flow to the brain (ischemia), which in some cases may lead to serious and life-threatening complications. The most common symptoms associated with PRES and RCVS include headache, nausea, and seizures.
This revision is based on new data from pharmacovigilance databases and the medical literature on a small number of cases of PRES and RCVS reported in people taking pseudoephedrine-containing medicines.
Medications containing pseudoephedrine are known to carry a risk of ischemic cardiovascular and cerebrovascular events (side effects involving ischemia of the heart and brain), including stroke and myocardial infarction. Limitations and warnings are included in the product information to reduce these risks.
Taking into account the seriousness of PRES and RCVS, the overall safety of pseudoephedrine and the indications for which the medicine is approved, EMA will review the available evidence and decide whether the marketing authorization of medicines containing pseudoephedrine should be maintained, modified or suspended throughout the EU Withdrawal within range.