This article was sponsored and developed in collaboration with PSA and Carers NSW[/caption]
However, pharmacists may perceive medication errors or non-adherence as a carer’s inability to fulfil this role,
The Therapeutic Goods Administration (TGA) issued an alert over the use of broad-spectrum antibiotics commonly used to treat infections such as urinary tract, respiratory and gastrointestinal infections.
What class of antibiotics prompted the alert?
Antimicrobials from the broad-spectrum fluoroquinolone class of antibiotics, including ciprofloxacin, norfloxacin and moxifloxacin. This includes all oral and injectable forms of fluoroquinolones.
What are the documented adverse effects?
Central nervous system (CNS) and psychiatric events. Although rare, the complications are serious – and are potentially disabling and irreversible.
Adverse events include:
- tremors, restlessness, light-headedness
- hallucinations or seizures (very rarely)
- tendonitis and tendon ruptures
- psychiatric reactions, including confusion, anxiety and depression.
These adverse effects can occur in patients who do not have any known risk factors. A notable case involved the suicide of a respected UK-based consultant cardiologist who died 11 days after starting ciprofloxacin treatment for prostatitis before undergoing a biopsy for prostate cancer investigations.
The coroner noted that in a letter left for his wife, the doctor expressed ‘uncharacteristically confused and illogical’ worries.
What’s changing?
There will be updates to the Product Information (PI) and Consumer Medicine Information (CMI) for all oral and injectable fluoroquinolones to raise awareness among healthcare professionals and patients about severe adverse effects.
For example, the boxed warning for ciprofloxacin will now state:
Serious disabling and potentially irreversible adverse reactions
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions involving different body systems that have occurred together in the same patient. Patients of any age or without pre-existing risk factors have experienced these adverse reactions. These include but are not limited to serious adverse reactions involving the nervous system (see section 4.4 Effects on the CNS), musculoskeletal system (see section 4.4 Tendonitis and tendon rupture) and psychiatric effects (see section 4.4 Psychiatric reactions).
Why is this change occurring?
A 2023 investigation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) examined severe adverse effects linked to fluoroquinolones. The review found that earlier measures taken by the MHRA in 2019, aimed at limiting prescriptions for minor, temporary, or non-bacterial illnesses (such as non-bacterial prostatitis), did not significantly decrease usage rates. The MHRA advised enhancing safety warnings and directly informing healthcare providers about these risks.
Following a review of this issue, prominent ‘boxed warnings’ will now be added to Australian PI and CMI to clearly communicate these serious adverse effects, consistent with international regulatory guidance.
What should pharmacists do?
Fluoroquinolones should be reserved for patients who have no other treatment options. Pharmacists should ensure that fluoroquinolones are prescribed judiciously and in line with antibiotic guidelines.
When dispensing fluoroquinolones such as ciprofloxacin, norfloxacin and moxifloxacin, pharmacists should advise patients to be aware of any unusual symptoms following initiation of treatment. Patients should be advised to seek medical advice in the event of an adverse reaction, with fluoroquinolone treatment promptly ceased.
