The TGA is investigating Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection

is following up on FDA (USA) and EMA (EU) drug agencies studies on Fluoroquinolones are broad-spectrum antibiotics that are active against both Gram-negative and Gram-positive bacteria. If you are taking any of the following antibiotics, please be vigilant.

• Ciprofloxacin
• Norfloxacin
• Moxifloxacin

Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection

12 April 2019

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.

Please followup at the TGA website for further information.