Is this a new health scandal that was revealed on Monday on the antenna of France Info? A dozen patients, victims of serious adverse effects of fluoroquinolones have taken legal action. This family of antibiotics marketed under various names (Oflocet, Ciflox, Tavanic, Izilox and their generics) is in principle reserved for the treatment of serious bacterial infections. But many doctors prescribe them for trivial cystitis, otitis or sinusitis. This is what happened to the plaintiffs, whose state of health is said to have seriously deteriorated, who are filing a complaint once morest their doctors and once morest X. They are demanding the opening of a criminal investigation to establish the responsibility of the authorities. health.
According to this patient association, six million prescriptions in breach of medical recommendations have been made over the past 3 years. Because as early as 2018-2019, the European Medicines Agency (EMA) reassessed the benefit/risk ratio of fluoroquinolones, “given the seriousness of some of the adverse effects, such as damage to the nervous system (peripheral neuropathies), neuropsychiatric disorders, musculoskeletal system disease (pain and swelling in the joints, inflammation or even rupture of the tendons, pain and/or weakness in the muscles), and their long-lasting, disabling and potentially irreversible nature“. This reassessment led to their indications being restricted and their job security profile to be updated.
This is what the National Agency for the Safety of Medicines and Health Products (ANSM) indicates on its website, adding that information for health professionals has been disseminated throughout the European Union and in France. . Besides, “patients must be warned (…) of the need to contact their doctor quickly as soon as certain symptoms mentioned in this file appear“ indicates the ANSM.
Six million undue prescriptions?
Problem: This note was only published on October 20, 2022, followed, two months later, by an alert in the drug-indexed decision support system (SAM) for healthcare professionals. Was there a delay in the ignition of the French health authorities? For Olivier Blin, head of the clinical pharmacology department at AP-HM, “the risk of these drugs was known from the outset and was subject to the precautions for use appearing in their leaflets. The problem is that fluoroquinolones, like other antibiotics, are prescribed in France for infections where the benefit is not high enough. The ANSM sends alerts to health professionals but we see that this is not respected“.
Despite recurrent awareness campaigns, the prescription of antibiotics still remains “automatique” in France, the 4th most consuming European country behind Greece, Romania and Bulgaria. In 2021, no less than 700 prescriptions per 1,000 inhabitants were carried out, 80% in city care. According to the French pharmacology society ( SFPT), fluoroquinolones are “three times more prescriptions outside the recommendations than in the recommendations“.
If the responsibility of the practitioners is patent, “there is also a complexification of medicine, a mass of pharmacological data, an increasingly fine perception of the risk/benefit ratio that practitioners find it difficult to integrate“, emphasizes Professor Blin. “These drugs are too old for the pressure of the laboratories to have weighed“, estimates Professor Joëlle Micaleff, director of the regional center of pharmacovigilance. On the other hand, “the current conditions of practice caused by the shortage of doctors sometimes make it difficult to take charge on a case-by-case basis“Not to mention the recent antibiotic shortages,”who were able to add blur to the blur“.
