The TGA is investigating a rare but serious adverse event of aortic aneurysm/dissection associated with fluoroquinolone antibiotics.

Our investigation follows a Drug Safety Communication published by the US Food and Drug Administration (FDA) and recommendations made by the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to update local product information to include warnings regarding this risk.

Fluoroquinolones are broad-spectrum antibiotics that are active against both Gram-negative and Gram-positive bacteria.

Fluoroquinolone antibiotics marketed in Australia include:

• Ciprofloxacin
• Norfloxacin
• Moxifloxacin

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.

We are liaising with international counterparts and will investigate to see what regulatory action should be taken in the local context.

The TGA has not received any Australian adverse reports of aortic aneurysm or dissection/rupture associated with fluoroquinolones. However we continue to monitor the situation closely.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.

Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.

Acting Editor: Dr Grant Pegg

Deputy Editor: Mr Michael Pittman

Contributors include: Dr Rona Hiam and Dr Nicola Murphy