Strengthened warnings for broad-spectrum antibiotics

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 and Consumer Medicine Information for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects. These include:

• tremors, restlessness, light-headedness, and very rarely hallucinations or seizures
• tendonitis (inflamed tendons) and tendon ruptures
• psychiatric reactions, e.g. confusion, anxiety and depression. 

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 patients or their carers should do

You should immediately let your doctor know if you, your child or someone you care for who is taking a fluoroquinolone starts to have any of the symptoms listed above or any other unusual symptoms.

Ask for a Consumer Medicine Information leaflet for the fluoroquinolone that is being taken.

What health professionals should do

Be alert to the updated warnings in the Product Information for ciprofloxacin, norfloxacin and moxifloxacin.

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
• provide the relevant Consumer Medicine Information to patients to remind them of these effects, if needed
• promptly discontinue fluoroquinolones in the event of an adverse reaction and consider prescribing alternative treatment.

For more detailed information written for health professionals, including the full text of the additional warnings, see the Medicine Safety Update article.