ISSUE 2 APRIL
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 7 March 2025.
Summary
Fluoroquinolones, including ciprofloxacin, norfloxacin and moxifloxacin, are broad-spectrum antibiotics used against susceptible infections and are usually reserved for patients who have no other treatment options.
More prominent warnings are being added to the product information (PI) and consumer medicine information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects. These include:
- central nervous system stimulation leading to transient tremor, restlessness, light-headedness, confusion, and very rarely hallucinations or seizures
- tendonitis and tendon ruptures
- psychiatric reactions.
Although rare, these side effects can be disabling and potentially irreversible. They can occur in patients of any age without pre-existing risk factors and have been reported simultaneously in the same patient. The nervous system and psychiatric reactions can occur after the first dose.
These updated warnings do not apply to fluoroquinolone eye or ear drops.
What health professionals should do
Health professionals should:
- be aware of these potential serious side effects and are reminded to use fluoroquinolones judiciously in line with Australian antibiotic prescribing guidelines
- warn patients to be alert to any unusual symptoms following treatment with fluoroquinolones and to seek health advice
- promptly discontinue fluoroquinolones in the event of an adverse reaction and consider prescribing alternative treatment.
See the full article on the TGA website.
