Therapeutic Goods Administration (TGA) announces that, following the Medicines Safety Update (MSU) article regarding fluoroquinolone antibiotics and risk of aortic aneurysm/dissection in Apr 2019, the Product Information (PI) for fluoroquinolone antibiotics have been updated to include more information about various potential adverse events. Fluoroquinolone antibiotics marketed in Australia include ciprofloxacin, norfloxacin and moxifloxacin.
The TGA investigated a safety signal relating to the rare but serious potential adverse event of aortic aneurysm and dissection associated with these medicines. An aortic aneurysm is an abnormal dilation of the main artery in the body that can in some circumstances rupture or dissect. This can lead to haemorrhage and in severe cases result in death.
Recent epidemiologic studies have shown an association between fluoroquinolone antibiotic use and aortic aneurysm and dissection. All PIs for fluoroquinolone antibiotics are being updated to include a precaution regarding this risk, particularly in the older population, which aligns with similar warnings being required by other international regulators (including the European Medicines Agency and the US Food and Drug Administration). The precaution advises that fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection.
During the TGA's investigation, it was also identified that the PIs for these medicines should be updated to ensure that precautions regarding the potential adverse events of dysglycaemia and psychiatric adverse reactions are included for all products and the information presented consistently. The precaution for dysglycaemia also contains reference to hypoglycaemia and hypoglycaemic coma. The precaution for psychiatric adverse reactions is included under a separate heading titled 'Central Nervous System Effects'. It advises that these medicines have been associated with an increased risk of psychiatric adverse reactions including: toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations or paranoia; depression, or self-injurious behaviour such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These reactions may occur following the first dose and if patients experience any of these symptoms, they should inform their doctor immediately and discontinue the drug.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication/update-fluoroquinolone-antibiotics-and-adverse-events
In Hong Kong, there are 166 registered pharmaceutical products containing fluoroquinolones which are oral preparations or injectables for use in human, including ciprofloxacin (73 products), levofloxacin (56 products), moxifloxacin (6 products), norfloxacin (5 products), ofloxacin (25 products) and prulifloxacin (1 product). All products are prescription-only medicines. So far, the Department of Health (DH) has received 7 cases of adverse drug reaction related to levofloxacin and 1 case related to moxifloxacin. One of the levofloxacin cases is related to insomnia. All other cases are not related to aortic aneurysm and dissection, dysglycaemia or psychiatric adverse reactions.
Related news on the risk of aortic aneurysm and dissection of fluoroquinolones was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 15 Nov 2018, with the latest update posted on 28 Jun 2019. Letters to inform local healthcare professionals were issued by the DH on 15 Nov 2018.
Related news on the risk of central nervous system effects (such as hallucinations and confusion) of fluoroquinolones was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 13 May 2016, with the latest update posted on 22 Mar 2019. Letters to inform local healthcare professionals were issued by the DH on 13 May 2016.
Related news on the risk of serious low blood sugar levels and mental health side effects (such as disturbances in attention and delirium) of fluoroquinolones was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 11 Jul 2018. Letters to inform local healthcare professionals were issued by the DH on the same day.
In Jun 2019, the Registration Committee of the Pharmacy and Poisons Board decided that the sales pack labels and/or package inserts of registered pharmaceutical products containing fluoroquinolones for systemic use should be updated and include safety information on the risk of aortic aneurysm and dissection and central nervous system effects, and to remain vigilant on any related safety updates issued by overseas drug regulatory authorities for serious low blood sugar levels and mental health side effects.
The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Thursday, Feb 27, 2020
Issued at HKT 17:00
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