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Europe rules on harm from fluoroquinolone antibiotics

The European Medicines Agency (EMA) held a public hearing last year on the potentially permanent side effects of quinolone antibiotics. The resulting report from the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) incorporates the views of patients, health-care professionals and academics, including our group (see Its recommendations, such as restricting the use of these drugs, have been adopted by the EMA’s Committee for Medicinal Products for Human Use, and will be ratified by the European Commission next month.

Quinolone antibiotics accounted for almost 30 million antibiotic prescriptions in the United States in 2016 (see They are effective against a range of bacterial infections, and most people do not experience serious side effects. However, as noted in the EMA report, these drugs can impair mitochondrial function, trigger oxidative stress and result in epigenetic changes in tissues in up to 10% of cases. International campaigning by patient groups led to the formal recognition in 2016 by the US Food and Drug Administration of a potentially permanent multisystem syndrome — fluoroquinolone-associated disability (L. E. Tennyson and T. D. Averch Urol. Pract. 4, 383–387; 2017).

We and others (see Nature 555, 431–433; 2018) have established that people with this syndrome require a multidisciplinary approach to treatment, with input from physiotherapists, rheumatologists, orthopaedic surgeons, neurologists, musculoskeletal radiologists and occupational therapists. The evidence we submitted to the PRAC highlighted the importance of recognizing this debilitating drug reaction, and of referring patients to musculoskeletal or neurological specialist services, depending on their symptoms.

Nature 566, 326 (2019)



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