The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) made its recommendations following a review of serious adverse effects reported with the use of quinolone antibiotics given orally, parenterally or by inhalation. Such effects have been reported very rarely and mainly involve muscles, tendons and bones, and the nervous system.
The PRAC warns that fluoroquinolones should not be used to:
- treat infections that may be self-limiting or are not severe (eg, throat infections)
- prevent traveller's diarrhoea or recurring lower UTIs
- treat patients who have previously had serious adverse effects with a quinolone antibiotic
- treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
The PRAC recommends that fluoroquinolones should be used with caution, especially in those at higher risk of tendon injury caused by these antibiotics (including the elderly, organ transplant patients, patients with kidney problems and those being treated with corticosteroids).
The PRAC also recommends that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of an adverse effect involving muscles, tendons or bones (including an inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (including pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).
The PRAC recommends that medicines containing the non-fluorinated first-generation quinolone antibiotics (cinoxacin, nalidixic acid or pipemidic acid) should be removed from the market because they are authorised only for infections that should no longer be treated with this class of drug. Currently, there are no quinolones of this type marketed in the UK.
The prescribing information for individual fluoroquinolone antibiotics will be updated to reflect the recommendations.