Fluoroquinolones are among the most widely used antibiotics in both systemic and specialist medical fields, and in ophthalmology they are used in eye drops to treat many eye infections, including conjunctivitisas their ability to penetrate ocular tissues makes them particularly effective.
For years, there have been growing concerns about the risks in terms of antibiotic resistance, related to their increasing use, and today these drugs are also the focus of careful re-evaluation by European regulatory authorities due to their security profileparticularly with regard to serious, disabling and sometimes irreversible adverse reactions.
AWaRe classification
Fluoroquinolones are antibiotics that fall entirely within the Watch Group of classification AWaRe (Access, Watch, Reserve), introduced by the World Health Organisation in 2022.
The antibiotics Watch are broad-spectrum antibiotics, which are recommended only as first-choice options for patients with more severe clinical manifestations or for infections where pathogens are more likely to be resistant to narrow-spectrum antibiotics, such as upper urinary tract infections (UTI).
The antibiotics Access have a narrow spectrum of activity, with a good safety profile and generally low resistance potential.
Fluoroquinolones, precisely because they are Watch antibiotics, are among the treatment options that should be considered second-rate compared to other molecules with less impact on antibiotic resistance.
In this context, the AIFA (Italian Medicines Agency) deemed it necessary to launch an online information campaign on their correct use and published a guide aimed at healthcare professionals and one specifically dedicated to patients.
Undesirable effects of concern
Already in 2019, the European Medicines Agency (EMA) had introduced some major restrictions on the use of fluoroquinolones, based on evidence-based data highlighting significant risks for the musculoskeletal system and the nervous system.
The risk of serious adverse reactions was further confirmed by a review of the EMA's EudraVigilance database, which recorded 426 reports of disabling reactions to fluoroquinolones or quinolones, characterised by a duration of 30 days or more, over 21 years. The molecules most frequently implicated in these cases were ciprofloxacin, levofloxacin, ofloxacin and moxifloxacin.
The most common reactions, 30% of the total, involve the musculoskeletal system and include tendinitis, joint pain, neuropathy. One of the most severe and early reactions is the tendinitiswhich may occur as early as 48 hours after the start of treatment and affect the Achilles tendon in particular, but also other tendon districts. The risk is significantly increased in patients over 60 years of age, with kidney problems or undergoing transplantation.
If symptoms such as swelling, pain or inflammation occur, fluoroquinolones should be discontinued immediately and replaced with alternative antibiotic therapy. In addition, the concomitant use of corticosteroids should always be avoided.
Other adverse reactions of fluoroquinolones include general disorders (15%) and nervous system disorders (13%), in particular cognitive disorders, fatigue, insomnia, neuralgia and, recently, also mental disorders, with manifestations such as anxiety, panic and suicidal thoughts.
I most affected patients Adverse reactions occurred in a wide age range, between 30 and 69 years, with a slight predominance of females. Adverse events were also reported in previously healthy subjects, confirming the need for careful risk assessment prior to prescription.
The adverse reactions that were detected made it urgent for national and international health authorities to intervene to protect patients' health.
In the meantime, the Summaries of Product Characteristics of medicinal products belonging to this class of antibiotics are being updated precisely to incorporate this new evidence, while at European and national level there is a renewed call for caution and rationalisation of use.
Situation in Italy
In Italy at present, the authorised fluoroquinolones are ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin. According to data from the latest OsMed Report on the use of drugs in Italy, there was a slight decrease in the consumption of fluoroquinolones in 2023 (which accounted for 9.7% of the antibiotics prescribed, compared to 10.5% in 2022), but our country continues to show values above the European average, which stands at 6.9%.
The use of these antibiotics remains high in certain sections of the Italian population, especially the elderly (with a prevalence of use of 14.1%) and women between 20 and 59 years of age (5.2%).
Southern Italy still remains the geographical area with the highest levels of prescription, both in contracted and hospital care, with consumption double that of the North.
Vademecum for operators
To support healthcare professionals in the appropriate and prudent use of fluoroquinolones, AIFA has published seven key recommendations.
Firstly, it is reiterated that these antibiotics should not be prescribed for non-serious or self-limiting infections (e.g. for the prevention of traveller's diarrhoea or recurrent lower urinary tract infections), just as they are not indicated for infections of non-bacterial origin.
Prescription should be avoided even in the presence of safer and more appropriate therapeutic alternatives for mild or moderate infections.
Fluoroquinolones must not be administered to patients who have already experienced serious adverse reactions to these drugs. Extreme caution should be exercised when treating individuals at risk of tendinopathy, such as the elderly, patients with renal insufficiency or transplant patients, as well as patients being treated with corticosteroids, for whom co-administration is contraindicated. Physicians are required to informing patients to stop treatment immediately at the first sign of unwanted effects such as tendonitis, joint pain or swelling, muscle weakness or neurological symptoms. At the same time, they should warn patients to pay attention to any mood swingssuicidal or self-destructive ideations that may also occur at an early stage. Finally, it is essential report any suspected adverse reaction to the National Pharmacovigilance Networkthus contributing to the continuous monitoring of the safety profile of these antibiotics.
When not to prescribe a fluoroquinolone
In terms of indications, fluoroquinolones are not recommended for a long series of conditions.
The AIFA Note lists the cases in which systemic and inhaled fluoroquinolones should not be prescribed:
- in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic;
- for non-serious or self-limiting infections (such as pharyngitis, tonsillitis and acute bronchitis);
- for mild to moderate infections (including uncomplicated cystitis, acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease (COPD), acute bacterial rhinosinusitis and acute otitis media) unless other antibiotics commonly recommended for these infections are deemed inappropriate;
- for non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
- to prevent traveller's diarrhoea or recurrent lower urinary tract infections.
There are some situations in which the use of fluoroquinolones may be considered as second-line treatment, such as in the case of resistance to first-choice molecules, in the case of intolerance or side effects to alternative drugs, or when there has been therapeutic failure with more recommended antibiotics.
In light of the latest evidence, it is clear that fluoroquinolones must be considered antibiotics of second linewhose use is only justified in selected conditions and under clinical supervision. Promoting the rational use of these drugs not only helps to protect the health of patients, but is also an essential step in the fight against antibiotic resistance, a major global health emergency.
On the AIFA website, the Guide for health workers for the proper management and prescription of these antibiotics.
Regarding the issues related to the use of fluoroquinolones in the strictly ophthalmological field, we refer you to what has been published on our platform:
- Fluoroquinolones and the eye - Oculist Italiano
- Keratitis and resistance to fluoroquinolones - Oculista Italiano
- Adverse ocular reactions associated with fluoroquinolones: implications for intracameral use - Oculista Italiano
https://www.aifa.gov.it/documents/20142/2918343/Fluorochinoloni_guida_operatori_sanitari_09.06.2025.pdf
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