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TGA strengthens warnings on antibiotic side effects

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The Therapeutic Goods Administration (TGA) has issued a safety update on fluoroquinolone antibiotics, following the strengthening of product warnings to highlight ‘serious disabling and potentially irreversible’ side effects.
 
The move by the TGA comes in response to a 2023 review by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) into the serious side effects associated with fluoroquinolones.
 
The more prominent warnings, added to the product information and consumer medicine information for all oral and injectable (systemic) fluoroquinolones include:

• central nervous system stimulation leading to transient tremor, restlessness, light-headedness, confusion, and very rarely to hallucinations or seizures
• tendonitis and tendon ruptures 
• psychiatric reactions.

Fluoroquinolones are broad spectrum oral and intravenous antibiotics, usually used as a last line of defence against infections.
 
In Australia, more than 80 fluoroquinolone products are on the market, including ciprofloxacin, norfloxacin and moxifloxacin.
 
While many are available on the Pharmaceutical Benefits Scheme, there are restrictions on their use to prevent or reduce instances of antibiotic resistance.
 
However, the UK review found that regulatory changes by the MHRA in 2019 to restrict the medication’s use had not appeared to reduce prescribing rates in that area.
 
In contrast to the UK, Dr Michael Tam, a member of the RACGP Expert Committee – Quality Care, said Australia ‘doesn’t actually use a huge amount of fluoroquinolones’.
 
‘In Australia, I think there’s always been relatively good control of the use of fluoroquinolones; we tend to use the first and second-line antibiotics first,’ he told newsGP.

Dr Tam said Australia’s use of fluoroquinolones has fallen significantly in recent years.
 
According to a report from the Australian Commission on Safety and Quality in Health Care, ‘Antimicrobial use in the community: 2023’, the use of fluoroquinolones in Australia more than halved between 2015 and 2023 – from 0.42 daily defined doses per 1000 people per day, to 0.19.
 
‘Because fluoroquinolones are a potentially really useful group of antibiotics, in Australia there has been a tendency to preserve their use,’ Dr Tam said.
 
‘If we’re getting to that point, literally we’re getting bacterial infections that cannot be treated with oral medications.
 
‘So, as an individual prescriber, the odds that your patient will get the serious adverse events is really quite low; it’s very unlikely.’
 
As of December 2024, a search of the Database of Adverse Event Notifications for ciprofloxacin, norfloxacin and moxifloxacin showed:
 

• 128 adverse event reports involving the musculoskeletal system reported as serious
• 152 adverse event reports involving the nervous system
• 29 adverse psychiatric events, most commonly anxiety, depression and confusional state.

However, the inclusion of the events in the report did not mean they were confirmed or actually related to the medication named.
 
RACGP Expert Committee – Quality Care Chair, Professor Mark Morgan, said drug surveillance systems ‘should not rely on active reporting of adverse effects.’
 
‘GP electronic medical records are able to provide de-identified information to passively identify potential side effects after medication prescriptions,’ he told newsGP.
 
‘Big data approaches can do a better job of finding rare side effects and even estimate frequency.’
 
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adverse reactions fluoroquinolone TGA Therapeutic Goods Administration

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