Adverse events of fluoroquinolones use in primary care: a systematic review and meta-analysis

Problem

Fluoroquinolones are synthetic broad-spectrum antimicrobials used for the treatment of certain respiratory tract infections (RTIs) and urinary tract infections (UTIs). Their use is associated with a risk of adverse events (AEs). When considering prescribing an antimicrobial in primary care, a shared decision-making consultation should include an explanation of both the benefits and potential harms. This review aims to summarize the occurrence of common AEs associated with fluoroquinolones prescribed for any indication in primary care.

Approach

The approach used for this study is systematic review and meta-analysis. We searched for randomized controlled trials conducted in a primary care setting in the Cochrane Central Register of Controlled Trials, MEDLINE (Ovid), Embase, PubMed, and CINHAL. Fluoroquinolones had to be administered orally, for any indication and to adults only. A citation search was also performed. The main outcome was any reported AEs.

Findings

AEs were reported in 39 studies. Fluoroquinolones were prescribed for UTIs (54%) and RTIs (46%). Nausea, diarrhoea, headache, vomiting, dizziness, abdominal pain, rashes and vaginal itching were the most commonly reported AEs. A meta-analysis of AEs was performed which included 28 studies, not included were 9 studies that compared types or durations of fluoroquinolones and 2 studies that were not explicit about the type of AEs. Overall, central nervous system (CNS) related AEs (Peto odds ratio [OR] 1.40, 95% confidence interval [CI] 1.12-1.75, I2 0%) and gastrointestinal (GI) related AEs (Peto odds ratio [OR] 1.20, 95% confidence interval [CI] 1.06-1.36, I2=80%) were significantly more often associated with fluoroquinolone use when compared to any other antimicrobial. No significant differences were observed in the total number of AEs between the fluoroquinolones and any other antimicrobial. Withdrawal and discontinuity due to drug related AEs were higher for fluoroquinolones (Peto odds ratio [OR] 1.19, 95% confidence interval [CI] 1.00-1.42, I2=5%). Nearly 80 % of the studies had low reporting and attrition bias. Sensitivity analyses did not change these results.

Consequences

Fluoroquinolones uses are associated with more CNS-related and GI-related AEs compared to any other type of antimicrobial. This can be useful information in a shared decision making discussion on benefits and harms of fluoroquinolones in comparison with no or any other antimicrobial for any infections in primary care.