What are the criticisms of anti-cold medications?

“ I want to say to the French: don’t use them anymore! » In this sentence, the director of the ANSM, Christelle Ratignier-Carbonneil, refers to anti-cold medications. In an interview for Le Parisien, we learned that the National Medicines Safety Agency is indeed stepping up to the plate against these famous winter tablets against the symptoms of winter colds.

This public statement takes place in parallel with a press release from the agency, published on October 22, 2023, against these so-called “vasoconstrictor” drugs. The medicines concerned are:

• Active Cold
• Actifed Cold day and night
• Dolirhume Paracetamol and Pseudoephedrine
• Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine
• Humex Cold
• Nurofen Cold
• Rhinadvil Cold Ibuprofen/ Pseudoephedrine
• Rhinadvilcaps Cold Ibuprofen/ Pseudoephedrine

Several medical organizations support this recommendation aimed at discouraging their use: the College of General Medicine, the National Professional ENT Council, the National Order of Pharmacists and community pharmacists’ unions. But why ?

The benefit-risk balance is unfavorable for these drugs, according to the ANSM

Cold medications available without a prescription are called “vasoconstrictors” because they contain, among other things, pseudoephedrine. They aim to unblock the nose. The tablets combine pseudoephedrine with painkillers, such as paracetamol, and/or with an antihistamine. They also exist in a spray form, limited to medical prescription.

Vasoconstrictors are relatively effective against cold symptoms, particularly for clearing up congestion in the nose. When you have a cold, the blood vessels in the lining of the nose dilate, so that white blood cells can pass through and heal. The mucus is drained by this process, and flows out, so you blow your nose. Vasoconstrictors work well, because that they partially close the vessels.

The problem is that they pose risks because they act throughout the body. Tightening of the vessels can affect the heart, for example. “ Myocardial infarction and stroke may occur after use of vasoconstrictor medications (pseudoephedrine) to relieve cold symptoms », Explains the ANSM. These are extremely serious complications. They were highlighted in “ recent data from pharmacovigilance databases » and more broadly in medical studies.

These serious events are rare, the risk is low. But the ANSM highlights two problems:

• These events can occur “ whatever the dose and duration of treatment » (even without a prior risk factor);
• These medications are absolutely not essential: colds heal spontaneously in a week or ten days, and a few simple actions can help you get better (use physiological serum for the nose, drink very regularly, get some fresh air, etc.)

The problem is therefore a disproportion in the benefit-risk ratio, and this motivates the recommendations and authorizations for all pharmaceutical products. The balance must always be in favor of profits. In this case, the ANSM considers that the risks are greater than the benefits, and that the balance is therefore unfavorable for these drugs.

At the start of the year, the ANSM requested a re-evaluation of these anti-cold medications at the European level, from the Pharmacovigilance Committee (PRAC) of the European Medicines Agency (EMA). The re-evaluation is underway, and the decision is expected by the end of 2023, but the French agency did not wait for the conclusions to publicly reiterate its position against these pharmaceutical products.

“ Despite the implementation of measures, we see that cases persist. Recent data still shows serious effects, while the common cold is a benign pathology, which is why we are mobilizing with doctors and pharmacists », Explains Christelle Ratignier-Carbonneil to Le Parisien – who recalls that from 2012 to 2018, pharmacovigilance reported 307 serious cases linked to these drugs.

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