Related Experiment Videos
Antimicrobial safety: focus on fluoroquinolones
Robert C Owens1, Paul G Ambrose
1Division of Infectious Diseases, Department of Clinical Pharmacy Services, Maine Medical Center, Portland, Maine 04102, USA. Owensr@mmc.org
Summary
Quinolone antibiotics are generally well-tolerated, with most side effects being mild gastrointestinal or central nervous system issues. Rare but serious risks like tendon rupture and heart rhythm changes exist, necessitating careful patient selection.
Area of Science:
- Pharmacology
- Drug Safety
- Antimicrobial Agents
Background:
- Infrequent toxicities of certain drugs necessitate ongoing safety surveillance.
- Data from preclinical studies, clinical trials, and postmarketing surveillance are crucial for risk assessment.
- This review focuses on the safety and tolerability of quinolone antibiotics.
Purpose of the Study:
- To summarize safety and tolerability data for the quinolone class of antibiotics.
- To provide an overview of common and serious adverse events associated with quinolones.
- To inform healthcare providers about the risk-benefit profile of quinolones.
Main Methods:
- Review of safety and tolerability data from preclinical testing.
- Analysis of data from Phase 1-3 clinical trials.
- Inclusion of postmarketing surveillance data.
Main Results:
- Common adverse events include gastrointestinal issues (nausea, diarrhea) and CNS effects (headache, dizziness), typically mild.
- Less common but serious events involve the cardiovascular system (QT prolongation), musculoskeletal system (tendinitis, rupture), endocrine system (glucose dysregulation), renal system (crystalluria, renal failure), and CNS (seizures).
- Severe idiosyncratic reactions are agent-specific; some quinolones with higher discontinuation rates (e.g., trovafloxacin) are no longer marketed.
Conclusions:
- Currently marketed quinolones exhibit favorable safety profiles, comparable to other antimicrobial classes.
- While generally well-tolerated, quinolones may present a higher incidence of tendinitis and CNS effects than other antimicrobials.
- Rare adverse events like Torsades de Pointes, hepatotoxicity, and dysglycemias can occur in susceptible populations and may be managed by avoiding specific agents or weighing therapeutic benefits against risks.