Fluoroquinolones linked to aortic aneurysms


The TGA says it is monitoring the safety of fluoroquinolones after receiving global alerts of a link to aortic aneurysms and dissections.

Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recommended that local product information be updated to include the serious but rare adverse event.

In its Drug Safety Communication the FDA advises clinicians to avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm.

However the TGA says it has not received any reports of aortic aneurysm or dissection/rupture associated with the antibiotics but would continue to liaise with its international counterparts to determine what action, if any, needed to be taken locally.

Fluoroquinolone antibiotics have recently made headlines in the UK, following an EU-wide safety review.

In a drug safety update the Medicines and Healthcare products Regulatory Agency (MHRA) said long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems lasting for 30 days or more had been reported in 286 cases in the EU over a 21-year period.

Fluoroquinolone antibiotics currently marketed in Australia include: ciprofloxacin, norfloxacin, and moxifloxacin.

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