Flagship cold treatments, pseudoephedrine drugs have been linked to brain damage. The European Medicines Agency decides to re-examine them.
Actifed®, Nurofen®, Humex®, Dolirhume®… Do you know what these medicines indicated to unclog the nose in case of cold, flu or allergy? They all contain pseudoephedrinea substance that causes constriction or the narrowing of blood vessels (hence their other name “vasoconstrictors“) et reduces mucus production in the nose. On February 10, the European Medicines Agency (EMA) announced in a communiqué initiate a review of these drugs following the identification of “a small number of cases” posterior reversible encephalopathy syndrome and of reversible cerebral vasoconstriction syndrome. These conditions affecting the blood vessels of the brain can reduce blood supply (ischemia) and lead to complications “major and potentially fatal”. The review undertaken by the EMA was initiated at the request of the French Medicines Agency (ANSM). EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will analyze this data and then decide “if the marketing authorizations of the drugs containing pseudoephedrine have to be maintained, modified, suspended or withdrawn. across the EU”.
What symptoms should alert?
Common symptoms associated with posterior reversible encephalopathy syndrome and at reversible cerebral vasoconstriction syndrome include headaches, nausea and seizures.
What are the drugs containing pseudoephedrine in France?
According to list updated by ANSM in December 2022, pseudoephedrine is a substance present in France in the following medicines:
- ACTIVATE RHUMEcompressed
- ACTIFED COLD DAY AND NIGHT, tablet
- DOLIRHYMS PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet
- DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, tablet
- HUMEX RHUMEtablet and capsule
- NUROFEN RHUMEcoated tablet
- RHINADVIL COLD IBUPROFEN/PSEUDOEPHEDRINE, coated tablet
- RHINADVILCAPS COLD IBUPROFEN/PSEUDOEPHEDRINE 200 mg/30 mg, soft capsule
- RHINUREFLEXcoated tablet
- RHUMAGRIPcompressed
Drugs containing pseudoephedrine are already associated with a known risk of ischemic events cardiovascular and cerebrovascular events, including stroke (AVC) and the heart attack. Of the restrictions and warnings are already included in the leaflets of these medicines in order to reduce these risks.
Source : PRAC starts safety review of pseudoephedrine-containing medicines, EMA, 10 février 2023
