EMA Communication on Fluoroquinolone and Quinolone Antibiotics
EMA's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation of the Risk Assessment Committee for the Pharmacovigilance (PRAC) and concluded that the marketing authorization for quinolone medicines should be suspended.
The CHMP also concluded that the use of the remaining fluoroquinolone antibiotics should be restricted.
The product information will be updated to describe disabling and potentially permanent side effects and will advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving the muscular system, tendons or joints and nervous system.
Related news: EMA Communication on Fluoroquinolone and Quinolone Antibiotics (16/11/2018)
Note. Quinolones and fluoroquinolones are antibiotics used to fight infections caused by Gram-negative and Gram-positive bacteria. They include the active substances cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.
As part of a review initiated in February 2017, at the request of the German medicines authority (BfArM), carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), several anomalies emerged which led the European Agency for medicines (EMA) to review the serious, disabling and potentially permanent side effects associated with the use of these medicines, given by mouth, injection or inhalation.
Well, with reference to medicines containing the active ingredients cinoxacin, flumequine, nalidixic acid and pipemidic acid, EMA's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), concluding that the relevant marketing authorizations should be suspended. Whereas, for all other fluoroquinolone antibiotics, the CHMP concluded that their use should be restricted.
