The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restricting the use of fluoroquinolone antibiotics and removing quinolone products from the European market. The decision follows a public hearing on the drugs in June.
Following its evaluation, the PRAC has recommended that all quinolone-containing products be removed from the market and that the remaining fluoroquinolone antibiotics should not be used for:
- Mild infections that may resolve without treatment
- Prevention of traveller’s diarrhoea or recurring lower urinary tract infections
- Patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic
- Mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used
The committee has also advised that these medicines should be used with caution in elderly patients, those with kidney problems, patients who have undergone organ transplantation or those being treated with systemic corticosteroids.
The PRAC has recommended that healthcare professionals should advise patients to discontinue fluoroquinolone treatment at the first sign of a side effect involving muscles, tendons or bones, or the nervous system.