Fluoroquinolones: old drugs, putative new toxicities

Area of Science:

• Pharmacovigilance
• Drug Safety
• Regulatory Science

Background:

• Fluoroquinolone (FQ) antibiotics, approved in 1986, are used for infections like UTIs, sinusitis, and bronchitis.
• Recent reports indicate numerous adverse events associated with FQ use, prompting regulatory review.

Approach:

• This review examines international regulatory agency actions and guidance concerning FQ-associated toxicities.
• Key focus areas include long-term disability and aortic aneurysm/dissection risks.

Key Points:

• US FDA guidance in 2016 cautioned against first-line FQ use for common infections due to potential disabling toxicity.
• EU agencies warn against using FQs for mild infections.
• Product labels in Australia, New Zealand, Japan, and Canada lack disability warnings, unlike revised US, EU, and Japan advisories regarding aortic risks.

Conclusions:

• Harmonization of warnings, particularly for FQ-associated disability, is recommended.
• Discrepancies in regulatory warnings across different countries highlight the need for consistent global drug safety standards.