The Therapeutic Goods Administration (TGA) announces that 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 to 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.
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. Fluoroquinolones are broad-spectrum antibiotics that are active against a wide range of bacteria, including gram-negative and some gram-positive organisms. Oral and intravenous fluoroquinolone antibiotics marketed in Australia include ciprofloxacin, norfloxacin, moxifloxacin.
A 2023 review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) into the serious side effects associated with fluoroquinolones found that regulatory changes taken by the MHRA to restrict use in 2019 had not appeared to reduce prescribing rates. 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.
After investigating this issue, the TGA is 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. Boxed warnings are included on the first page of PIs and CMIs to highlight significant medicine safety risks. The boxed warning will be included in the Australian PIs for oral and injectable ciprofloxacin, norfloxacin and moxifloxacin products and relates to existing information in Section 4.4 Special warnings and precautions. Health professionals should refer to the PI of the relevant product for more detailed information as the wording in section 4.4 differs between products.
The boxed warning text (ciprofloxacin is given as the example) is:
- 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).
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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/more-prominent-warnings-about-serious-side-effects-fluoroquinolone-antibiotics
In Hong Kong, there are registered pharmaceutical products containing oral and injectable (systemic) fluoroquinolones for use in human, including ciprofloxacin (49 products), levofloxacin (42 products), moxifloxacin (6 products), norfloxacin (3 products), ofloxacin (12 products), prulifloxacin (one product) and delafloxacin (2 products). All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction with regard to levofloxacin (13 cases; of which 3 cases were reported as musculoskeletal, nervous and/or psychiatric reactions) and ofloxacin (4 cases; all of these cases were reported as attempted suicide/completed suicide). The DH has received adverse drug reaction related to ciprofloxacin (2 cases) and moxifloxacin (one case), but these cases were not related to the disabling side effects mentioned in the above TGA’s announcement. The DH has not received any case of adverse drug reaction related to norfloxacin, prulifloxacin and delafloxacin.
Related news on the risk of musculoskeletal, nervous and psychiatric adverse reactions associated with the use of fluoroquinolones was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 8 Nov 2011, with the latest update posted on 23 Jan 2024. Letters to inform local healthcare professionals were issued by the DH on 8 Nov 2011, 16 Aug 2013, 13 May 2016, 11 Jul 2018, 8 Oct 2018 and 23 Jan 2024.
The Registration Committee of the Pharmacy and Poisons Board discussed the matter related to the above risks associated with the use of fluoroquinolones in Sep 2016, Jun 2019 and Sep 2024. Currently, the sales pack labels and/or package inserts of locally registered pharmaceutical products containing fluoroquinolones for systemic use should contain safety information about the risk of disabling and potentially irreversible serious adverse reactions, including tendinitis, tendon rupture and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Mar 7, 2025
Issued at HKT 19:00
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