The Aemps recommends avoiding flu medications with pseudoephedrine in patients with hypertension or kidney disease

2023-12-05 12:05:26

The Spanish Agency for Medicines and Health Products (AEMPS) has recalled that people with severe hypertension or uncontrolled and patients with renal disease or kidney failure should avoid pseudoephedrine, authorized in Spain alone or in combination with other active ingredients for short-term symptomatic relief of nasal or sinus congestion caused by the common cold or rhinitis.

Some medications containing pseudoephedrine are marketed under various trade names, such as ‘Gelocatil Gripe con pseudoephedrine’, ‘Frenadol decongestive 16 capsules’, ‘Cinfatós decongestivo’, ‘Reactine cetirizina pseudoephedrine’, ‘Actifed’, ‘Aerinaze’, ‘Aspirin Complex’ , ‘Clarinase’, ‘Humex rhume’ and ‘Nurofen Cold and Flu’.

Recently, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (CRVS) have been reported in the European Union following the use of pseudoephedrine. Both conditions they are very rare, presenting a reduction in cerebral blood flow due to involvement of blood vessels. Its symptoms generally resolve with prompt diagnosis and treatment, although occasionally they can cause serious complications and be life-threatening. However, no fatal cases of PRES or RCVS have been reported with pseudoephedrine.

Following knowledge of these cases, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has carried out a review of all available evidence. After completing the evaluation, the PRAC has recommended the contraindication of use of medicines containing pseudoephedrine in patients with severe hypertension or uncontrolled and in patients with severe kidney disease (acute or chronic) or with kidney failure, as these are conditions that increase the risk of PRES and RCVS.

The PRAC also recommends that healthcare professionals warn patients about the need to stop treatment immediately and seek healthcare if they develop symptoms of PRES or SVCRsuch as sudden intense headache, thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.

The recommendations must be ratified by the Committee for Medicinal Products for Human Use (CHMP), of which all European medicines agencies are part and, ultimately, by the European Commission, which will conclude with a final and binding decision for the entire Union. European.