The TGA is implementing boxed warnings about the serious side effects of these antibiotics.
The broad-spectrum oral and injectable antibiotics ciprofloxacin, norfloxacin and moxifloxacin are associated with serious musculoskeletal, nervous system and psychiatric adverse events, the TGA has reminded clinicians.
The regulator decided to emphasise these risks on product information and consumer information (except for the eye or ear drops) after a 2023 review by the UK’s Medicines and Healthcare products Regulatory Agency found that regulations implemented in 2019 to restrict their use did not seem to have worked.
“These regulatory changes stated that fluoroquinolones should not be prescribed for non-severe or self-limiting conditions, or non-bacterial conditions, for example non-bacterial prostatitis. As a result, the MHRA review recommended several updates to the safety information to highlight the risks of these side effects. They also recommended the updates should be communicated directly to health professionals,” the TGA update said.
“After investigating this issue, we are introducing ‘boxed warnings’ to the Australian PIs and CMIs to raise awareness of these serious side effects in line with warnings from other international regulators.”
Australian guidelines emphasise that fluoroquinolones are a valuable reserve antimicrobial. There are more than 80 products on the market, but PBS restrictions have kept usage levels in check and resistance in the community low.
However, their use is increasing globally and resistance is emerging.
Fluoroquinolones are indicated for urinary tract infections, pneumonia, gastroenteritis and gonococcal infections. “Oral ciprofloxacin and norfloxacin treat resistant Gram-negative infections such as Pseudomonas, gastroenteritis in immunocompromised patients, osteomyelitis, epididymo-orchitis and prostatitis. Ciprofloxacin is especially effective against Pseudomonas aeruginosa, and is actually the only oral option for the treatment of this bug. Moxifloxacin has additional broader-spectrum activity against anaerobes and Gram-positives, including Streptococcus pneumoniae, and is available largely in hospitals and on private, non-PBS scripts for patients with penicillin hypersensitivity,” haematology fellow Dr Diva Baggio told Australian Prescriber Podcast in 2021.
Related
Patient-reported allergies to other antibiotics, especially beta-lactams, have also been noted as a consideration when prescribing, and investigation into whether a patient is still allergic is suggested.
At the end of last year, there were 128 serious adverse events related to the musculoskeletal system reported in the Database of Adverse Event Notifications (DAEN), which involved GPs, hospital admissions or hospital emergency visits. Tendonitis, arthralgia and myalgia were the most common. There were 152 serious nervous system adverse events, mostly peripheral neuropathy, headache and paraesthesia. And there were 59 serious psychiatric events, most often confusion, anxiety and depression.
The TGA warning will read as follows:
“WARNING: Serious disabling and potentially irreversible adverse reactions
“Fluoroquinolones … 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 … musculoskeletal system … and psychiatric effects.”
