The French health agency has warned that some readily-available cold medications should not be used due to potentially severe side-effects.
Pharmacists and doctors have been warned against prescribing these drugs by the medicines safety authority ANSM (l’Agence nationale de sécurité du médicament et des produits de santé). It has raised the alarm previously but has repeated the same advice after concerns that people may still be using them.
“We have been advising against them for years,” said Philippe Besset, president of the pharmaceutical union la Fédération des syndicats pharmaceutiques de France, to Le Parisien.
The advice is supported by GP and pharmaceutical authorities and unions including the Ordre national des pharmaciens and the Collège de la médecine générale.
Severe side effects
The drugs can - in very rare cases - cause serious side effects that are worse than the original flu or cold. This is described as an insufficient ‘benefit-risk ratio’.
The medicines are already considered harmful for people with hypertension, diabetes, a history of stroke or convulsion, heart problems, hyperthyroidism, ocular glaucoma, and pregnancy.
“Heart attacks and strokes can occur after their use,” said the director of the ANSM, Christelle Ratignier-Carbonneil to Le Parisien. “The risk is very low, but these very serious events can occur regardless of the dose and duration of treatment. I want to tell everyone in France: Do not use them anymore.”
She told FranceInfo: “There is no point risking a stroke for a blocked nose.”
These severe side effects can occur because the drugs are ‘vasoconstrictors’ - the chemical pseudoephedrine - which cause your body’s blood vessels to close up slightly. This stops your nose from running, as this is caused by the blood vessels dilating to allow the circulation of more of your immune system’s white blood cells.
But the drugs do not only constrict the blood vessels in your nose; it happens all over the body. If you already have a heart problem, this extra narrowing can cause a total blockage and lead to a heart attack or stroke.
‘Too many’ boxes still sold
In February, the European Union decided to re-evaluate the safety of these drugs, but French authorities have said there is no need to wait for the EU’s conclusions (expected at the start of 2024), and that people should stop taking the medicines now.
“Despite the measures that have been put in place, cases continue to occur,” said Ms Ratignier-Carbonneil. “Recent data still show serious effects, even though the common cold is benign, which is why we are working with doctors and pharmacists [to stop the use].”
Between 2012 and 2018, the national pharmacology database recorded 307 serious issues caused by these medicines. Three million boxes of the drugs were sold in 2021, up from 2.8 million in 2020, but down from 11 million in 2014, and 16 million in 2010.
“This is still too many.” said Ms Ratignier-Carbonneil.
Some of the forms of the medicines are only available on prescription, but some are available to buy from pharmacy shelves.
‘Withdraw them from sale’
Pharmacologist Jean-Paul Giroud, author of 33 medical books and a member of the Académie de Médecine, has been warning for years about vasoconstrictors for years, and has called for them to be withdrawn from sale completely.
During his career as head of department at the Parisian hospital Cochin, he saw “dozens and dozens of patients” fall victim to these tablets.
“Do you think that every time you buy them, [the pharmacists] check whether your state of health is compatible? The answer is no!” he said. “The best thing to do is to withdraw them from the market for good.”
List of medicines to avoid
The medicines to avoid are those in tablet form that aim to stop a running nose (decongestants), including:
- Humex Rhume
- Actifed Rhume
- Nurofen Rhume
- Rhinadvil Rhume
Instead, people with a blocked nose can find relief by using sea salt nose sprays, or by inhaling steam from hot water with menthol, said Ms Ratignier-Carbonneil.