A new advisory issued by the European Medicines Agency (EMA) notes that the adverse effects of pseudoephedrine medicines used to relieve nasal congestion may be serious and life-threatening in people with severe or uncontrolled hypertension and patients with kidney disease. , in which it recommends that these types of drugs are contraindicated.
The new contraindications for the use of pseudoephedrine are based on an analysis by the Pharmacovigilance Risk Assessment Committee (PRAC) of the available evidence on these drugs with the aim of minimizing the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), after several cases have been reported in the European Union.
The Spanish Agency for Medicines and Health Products (Aemps) has explained that these pathologies are very rare and are characterized by a reduction in cerebral blood flow due to the involvement of blood vessels. Although they are generally reversible, they can be very serious, and even cause the death of the patient.
Awaiting a binding decision on the use of pseudoephedrine
Pseudoephedrine is used alone or in combination with other substances for short-term symptomatic relief of nasal or sinus congestion caused by common conditions such as colds or rhinitis and, according to Aemps, 23 medicines containing pseudoephedrine are marketed in Spain. among them Frenadol decongestant, Gelocatil influenza with pseudoephedrine, or Termalgin cold.
Health recommends that people with very high or uncontrolled blood pressure and kidney patients do not take drugs with pseudoephedrine to minimize the risk of developing PRES and RCVS.
The PRAC evaluation has been carried out over the past 10 months and has concluded that pseudoephedrine is associated with an increased risk of PRES and CRVS. The process that has just concluded constitutes a prior step to the ratification of the Committee for Medicinal Products for Human Use, of which European regulators are part and, subsequently, by the European Commission, which will make a binding decision.
The technical specifications and leaflets of the medicines will be updated with the new information, but, in the meantime, the Ministry of Health recommends that people with very high or uncontrolled blood pressure and kidney patients do not take this drug to minimize the risk. risk of developing these syndromes which, although they have a very low incidence, can be fatal.
In addition, they indicate that patients being treated with pseudoephedrine should urgently see a doctor if they experience symptoms such as headache, nausea, vomiting, confusion, seizures, and visual disturbances. The EMA has also recommended that healthcare professionals warn patients likely to be affected by the adverse effects of pseudoephedrine and withdraw them from medicines that include it.
