Updates to Fluoroquinolone Safety Alert

December 20, 2018 – The U.S. FDA has updated a safety alert originally issued in May 2017 regarding fluoroquinolone antibiotics. These antibiotics, when used systemically, may raise a patient’s risk of rare but serious ruptures or tears in the aorta. This can lead to life-threatening bleeding, and may occur with either oral or injectable fluoroquinolones.

As a result, the FDA advises that fluoroquinolones should not be used in certain patients unless all other treatment options have been exhausted. These patients include the elderly, and individuals who have high blood pressure, certain genetic disorders associated with blood vessel changes, or a history of blockages or aneurysms in the aorta or other blood vessels. The FDA is also requiring a new warning be added to the prescribing information and Medication Guide for all fluoroquinolone products.

Fluoroquinolone antibiotics have been in use in the United States for more than three decades, and are used to treat a variety of bacterial infections. The FDA cautions that patients should not stop taking any fluoroquinolone that they have been prescribed without first speaking to their healthcare provider. Patients should seek medical help immediately if they experience sudden, severe, and constant pain in the stomach, chest or back. Any unusual side effects experienced while on fluoroquinolone should be reported to the prescriber immediately, as aortic aneurysms may often be difficult to identify until they burst or become large.

The full safety alert can be found at: https://www.fda.gov/Drugs/DrugSafety/ucm628753.htm