2023-09-17 23:17:55
The US Medicines Agency has concluded that phenylephrine, a component of cold medicines used for decades, is ineffective.
A widely used drug that would actually be of no use? This is what the American Medicines Agency, the Food and Drug Administration (FDA), concluded regarding phenylephrine, a substance belonging to the family of vasoconstrictors, drugs used to decongest the nose. The organization declared that these medications, used by many patients, were completely useless in curing a cold.
In France, phenylephrine is no longer marketed for the treatment of colds, but has been replaced by another substance with a similar mode of action: pseudoephedrine. The latter is the component of medications available without a prescription such as Dolirhume or RhinAdvil, among others. Vasoconstrictors simply shrink the size of the blood vessels, and therefore reduce the swelling of the nasal mucosa. This mode of action certainly reduces the runny nose, but only alleviates a symptom, without treating the condition itself. Furthermore, insists Séverine Carré-Pétraud, publishing director of the medical journal Prescrire, “the cold is a benign infection which heals spontaneously, without doing anything”. Resorting to medication is therefore not necessary.
Not very effective, and sometimes even dangerous
Since the creation of Prescrire in 1980, doctors have denounced in the pages of the medical journal the low effectiveness of this type of medication, and especially the risks to which patients are exposed by using them. Numerous cases of cardiovascular accidents have, among other things, been reported. The publication director believes that taking these medications presents “disproportionate risks compared to benign conditions such as colds or rhinitis”. “There are serious, even fatal, adverse effects that have been established, that have been documented,” she adds.
Health services have been aware of these problems for a long time. The High Authority for Health has revoked the reimbursement of decongestants containing pseudoephedrine for around ten years, judging that they represented too great a risk for the patient’s health in view of too little clinical benefit. The National Agency for the Safety of Medicines and Health Products (ANSM) has also published a number of warnings on this subject. Pharmacists are now asked to inform users before dispensing them with one of these products. “This is a category of medicines which has been the subject of several measures at the national level to try to regulate its prescription as well as its delivery,” notes the ANSM. “We provide information about the risks, but the drugs are still there,” wonders Séverine Carré-Pétraud.
Reassessment in progress
In France, for the marketing of a drug to be called into question, it must first go through a re-evaluation at European level. At the request of France, the safety committee of the European Medicines Agency (EMA) began the re-evaluation of pseudoephedrine in February.
Ultimately, this review could lead to the withdrawal of these drugs from sale or the restriction of their delivery under certain conditions. “As long as the examination is in progress, we cannot make comments or speculate on the final result,” indicated the AEM, contacted by Libération on this subject.
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