Antibiotics prescribed off-label that have produced serious adverse effects. Here is the heart of the case taken up by three lawyers: Me Noémie Klein, Maxime Bailly and Martin Vettes announced Monday, March 13 by press release the upcoming filing of a series of complaints aimed at "unintentional injuries". The lawyers represent the interests of Philippe Coville, who already filed a lawsuit last October, and a "dozen other patients" who "have taken fluoroquinolone antibiotics and suffer from adverse effects that are sometimes serious and potentially irreversible".
According to this advice, "despite several alerts on their dangerousness, in particular from Mr. Coville, and the restrictions of indications that intervened late in 2019 with regard to their adverse effects known for years, these antibiotics remain today massively prescribed outside the scope of the marketing authorization [AMM]".
A number of these patients "believe that they were not informed both of the off-label prescription of the antibiotic that was issued to them, but also of the adverse effects they began to suffer from immediately after their consumption", further write the lawyers.
All of these patients hope through these complaints for "unintentional injuries" and "aggravated deception" to obtain the opening of an investigation by the public health unit of the Paris court "in order to centralize the investigations", while the first Mr. Coville's complaint, filed in Paris, was, according to one of the advisers, disoriented with the Versailles court.
On its website, the National Medicines Safety Agency (ANSM) states that "Fluoroquinolones are a class of antibiotics that can be used in serious bacterial infections". "Like any drug, fluoroquinolones can cause undesirable effects", warns the ANSM, referring to "damage to the nervous system", "neuro-psychiatric disorders", "a condition of the musculoskeletal system" , but also "very rare but serious cardiac adverse effects".
Since 2018-2019, the European Medicines Agency "has reassessed" their "benefit/risk ratio", leading in particular "to restricting their therapeutic indications and updating their job safety profile", recalls the ANSM. On its website, the national agency indicates that fluoroquinolones "should only be prescribed after carefully weighing their benefits against the risks of expected adverse effects, and after informing the patient of this".
