EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects.

These restrictions were introduced in 2019 following an EU-wide review of these very rare, but serious side effects. An EMA funded study  has shown that although the use of fluoroquinolone antibiotics has reduced, these medicines may still be prescribed outside of their recommended uses.

Restrictions on the use of fluoroquinolone antibiotics mean that they should not be used: 

• to treat infections that might get better without treatment or are not severe (such as throat infections); 
• to treat non-bacterial infections, e.g., non-bacterial (chronic) prostatitis; 
• for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
• to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Importantly, fluoroquinolones should be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and in those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.

The study2, which evaluated data from the primary care setting in six European countries (Belgium, France, Germany, the Netherlands, Spain and the United Kingdom) between 2016 and 2021, suggests that the measures taken to restrict the use of these medicines as a result of the EU-wide review had a modest impact.

A Direct Healthcare Professional Communication (DHPC) will now be sent to healthcare professionals in the EU. The DHPC will emphasise that these products should only be prescribed for their approved indications and after a careful assessment of the benefits and risks in individual patients.