Eight common cold and cough medicines to be pulled from open sale in France

These drugs containing the vasoconstrictor pseudoephedrine are banned from over-the-counter sale from December 11 due to the increased risk of complications

ANSM identified Dolirhume, Nurofen Rhume and Actifed Rhume among the eight medicines it considers potentially dangerous
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Eight drugs containing the vasoconstrictor pseudoephedrine have been banned from over-the-counter sale in France from December 11 due to the increased risk of complications they present.

Pseudoephedrine is included in certain drugs to improve cold symptoms by narrowing the blood vessels in the nose. 

However, as the molecule also affects other parts of the body it can lead to increased blood pressure and heart rate.

The French drug agency l’Agence nationale de sécurité du médicament (ANSM) says that pseudoephedrine can cause serious side effects, such as the risk of heart attack or stroke, even in healthy subjects. 

“The risk is very low, but these events can occur regardless of the dose and duration of treatment”, says ANSM.

The agency previously recommended banning the sale of the molecule in over-the-counter drugs in 2023.

Read more: French doctors repeat warning of stroke risk from common cold medicines

The eight drugs affected by the ban include:

  • Actifed Rhume, Actifed Rhume jour et nuit, 

  • Dolirhume Paracétamol and Pseudoéphédrine, 

  • Dolirhumepro Paracétamol Pseudoéphédrine and Doxylamine, 

  • Humex Rhume, 

  • Nurofen Rhume, 

  • Rhinadvil Rhume Ibuprofène/Pseudoéphédrine, 

  • Rhinadvilcaps Rhume, 

  • Ibuprofène/Pseudoéphédrine.

ANSM has fought for a ban on over-the-counter drugs containing pseudoephedrine for over a decade, having first become aware of the potential risks they pose in 2006.

At that time, the use of a pseudoephedrine to unclog blocked noses via a vasoconstriction effect, was judged to present a “disproportionate risk” to patients by the medical review Prescrire.

The national health advisory board, the Haut autorité de la santé (HAS), said in 2012 that the medical value of such treatments was “low[…] due to their insufficiently established efficacy and the cardiovascular risk”.

However, France cannot ban the drugs completely as their safety has been approved at a European level, meaning that patients with a prescription can still acquire them.