Health authorities in France have warned that a common cold medication can, in very rare cases, cause brain problems and even heart attacks, in an alert that has attracted the attention of the European Medicines Agency (EMA).
The EMA started a safety review of the medicine on February 10.
The warning from health authority Agence nationale de sécurité du médicament et des produits de santé (ANSM) concerns medicines based on pseudoephedrine. This is often found in commonly-used sprays, liquid, and tablets.
The drug can, in very rare cases, cause “issues with a risk of reversible posterior encephalopathy syndrome (RPEIS) and reversible cerebral vasoconstriction syndrome (RCVS)”, it said. Both are conditions that affect the blood vessels in the brain.
In some extremely rare cases, they can lead to strokes or heart attacks.
In practice, the medicines affected are relatively common, and include well-known cold remedies such as Actifed, Dolirhume, and Humex.
They work by relaxing blood vessels to help unblock the respiratory tubes when they are ‘stuffed up’ during a cold or flu-like episode.
The low risk of these brain issues are clearly marked on the leaflet inside the pack already.
However, the ANSM decided to issue a further warning to raise awareness, and the UK then launched an inquiry into the medicine as a result of the notice, and EMA response.
This is not the first time that the medicines have attracted criticism and alarm. As far back as 2016, consumer group 60 Millions de Consommateurs said that over-the-counter medicines such as Actifed, Humex, Dolirhume, Rhinédrine and Nurofen came at “too large a risk for a simple cold”.
The ANSM always warns people that remedies for the common cold only reduce the impact of symptoms, rather than cure the problem. It reminds people that the virus responsible will clear up on its own after a few days.