The European Medicines Agency EMA announces the start of a safety review of medicines containing pseudoephedrine, an active ingredient administered orally alone or in combination with others to treat stuffy nose caused by colds, flu or allergies, and symptoms related to nasal congestion such as headache, fever, pain and rhinitis.
The Prac Pharmacovigilance Committee of the EU regulatory body, in its last meeting on 6-9 February, decided to investigate these drugs – explains the EMA – after fears relating to serious ischemic risks associated with taking pseudoephedrine, potentially life threatening.
The Prac will review the available evidence and decide whether the marketing authorizations for pseudoephedrine medicines should be maintained, varied, suspended or withdrawn across the European Union.
The review of pseudoephedrine-based drugs is motivated by the possible risk of posterior reversible encephalopathy syndrome (Pres) and reversible cerebral vasoconstriction syndrome (RCVS), conditions that affect the cerebral blood vessels and which can lead to a reduced blood supply (ischemia) to the brain and in some cases cause serious and life-threatening complications. Common symptoms associated with Pres and Rcvs include headaches, nausea, and seizures. The review follows new data on a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines reported in pharmacovigilance databases and medical literature.
Medicinal products containing pseudoephedrine have a known risk of ischemic cardiovascular and cerebrovascular events, including stroke and heart attack. Restrictions and warnings to reduce these risks are therefore already included in the product information. But considering the seriousness of Pres and Rcvs, the safety profile of pseudoephedrine and the indications for which it is approved, the Prac will analyze all the available information and decide whether to change or revoke the authorization of the medicines that contain it.