EMA restricts fluoroquinolone and quinolone prescribing

In light of reports of rare but disabling side-effects of fluoroquinolone and quinolones, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the use of these antibiotics is restricted.

Fluoroquinolones and quinolones are broad-spectrum antibiotics that are effective against a wide range of Gram-negative and Gram-positive bacteria. The PRAC recently carried out a review of the side-effects of fluoroquinolones and quinolones, incorporating the views of patients, health professionals and scientists gathered at the EMA’s public hearing on the topic in June.

The PRAC recommends that all medicines that contain a quinolone antibiotic (eg nalidixic acid) should be removed from the market, because they are authorised only for infections that should no longer be treated with these medicines. Furthermore, fluoroquinolone antibiotics (eg ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin) should not be used for the following: to treat infections that are not severe or that may resolve without treatment; for the prevention of traveller’s diarrhoea or recurring lower urinary tract infections; in patients who have previously had a serious side-effect with a fluoroquinolone or quinolone; or to treat mild or moderately severe infections, unless other antibiotics cannot be used. Fluoroquinolones should also be used with caution in the elderly, in patients with kidney problems, in patients who have had an organ transplant or in those who are being treated with a systemic corticosteroid, due to a higher risk of tendon injury.

Healthcare professionals should advise patients to stop taking their fluoroquinolone treatment at the first sign of a side-effect involving muscles, tendons or bones (eg inflamed tendon, muscle or joint pain) or the nervous system (eg confusion, depression, paresthesia, vision or hearing problems). A final opinion on the PRAC recommendations will be issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in due course.


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