Anti-cold medications are no longer offered in French pharmacies and the national medicines safety agency recommends abandoning these tablets because they are too dangerous.
The cold season has begun and the National Medicines Safety Agency (ANSM) is once again warning against certain medications. Anti-cold tablets known as Humex, Acitfed and Dolirhume are in its sights. And the position of the drug policeman is clear, as proven by the declarations of the president of the ANSM, Christelle Ratignier-Carbonneil, in the columns of Le Parisien: “I want to say to the French: don’t use them anymore!” The cause ? Potentially very serious side effects for a mild illness and an unfavorable benefit-risk balance.
These anti-cold medications are vasoconstrictors that use the molecule pseudoephedrine and while their effects are almost immediate and radical in relieving a blocked nose, they can also pose risks. The principle of these tablets is to reduce the size of blood vessels, which has the effect of decongesting the nose and sinuses by deflating the mucous membranes. But this retraction of the vessels is not targeted and can occur anywhere in the body, including near the heart. “This tightening can cause total obstruction and lead to a stroke or heart attack” warns Doctor Gilles Munier, vice-president of the National Council of the Order of Physicians, to Le Parisien.
“The risk is very low but these events can occur regardless of the dose and duration of treatment” specifies the ANSM. Although cases are rare, they remain observed every year: 307 serious cases were recorded between 2012 and 2018 according to the national pharmacology database. A ratio considered too high and risks considered too serious by the drug police, to quickly treat a cold which generally resolves itself in 7 to 10 days.
The ANSM recommends against the use of these medications, which are available without a prescription at the pharmacy counter, as do the College of General Medicine, the National Professional ENT Council, the National Order of Pharmacists and the main unions of community pharmacists. . As a result, from October 23, these vasoconstrictors will no longer be highlighted, sometimes not even visible, in pharmacies and pharmacists are asked to advise against patients seeking these cold remedies. Faced with the most persistent colds, the ANSM asks for precise information on the benefits and risks.
This is a new step in the process to limit the use of cold tablets. Many pharmacists already point out the long list of contraindications which are hypertension, diabetes, history of stroke, convulsion, coronary insufficiency, hyperthyroidism, ocular glaucoma or even pregnancy. And advertising for these medications has been banned since 2017. Note that only anti-cold tablets are affected by these measures since the delivery of nasal sprays is already regulated and can only be done with a doctor’s prescription. Note that the use of vasoconstrictors has already decreased significantly, from 16 million boxes sold in 2010 to 3 million in 2021, but “it’s still too much” for Christelle Ratignier-Carbonneil.
But the scope of action of the medicine policeman ends there, because only the European Medicines Agency can comment on the banning of medicines. The European Union undertook a re-evaluation of these vasoconstrictors at the beginning of 2023 and must deliver an opinion in February 2024.
