The Food and Drug Administration (FDA) has determined that the use of fluoroquinolone antibiotics is associated with the rare adverse effect of rupture or dissection of aortic aneurysms. The agency has added a warning about this risk to the labeling for all fluoroquinolone antibiotics (for a list of FDA-approved fluoroquinolones, see Table 1). This warning will also be included in the medication guide provided with each filled prescription.
The association between fluoroquinolones and rupture or dissection of aortic aneurysms was discovered after a review of cases reported to the FDA's Adverse Event Reporting System database and four epidemiological studies published between 2015 and 2018. The risk appears to be independent of the route of fluoroquinolone administration, and its underlying mechanism has not been determined.
People at risk for aortic aneurysms include those with a history of peripheral atherosclerotic vascular diseases, hypertension, certain genetic disorders that involve blood vessel changes such as Marfan syndrome and Ehlers-Danlos syndrome, and the elderly.
This new warning for fluoroquinolones follows several other warnings, including one issued in July 2018 related to significant decreases in blood sugar and certain mental health adverse effects associated with these antibiotics, and a black box warning issued in July 2016 of tendonitis; tendon rupture; and problems with muscles, joints, nerves, and the central nervous system.
NPs should avoid prescribing fluoroquinolone antibiotics to those at risk for or who have a history of aortic aneurysm unless no other treatment is available. Patients prescribed fluoroquinolones who have been diagnosed with an aortic aneurysm should be instructed to promptly seek medical attention if they experience any signs or symptoms of aneurysm growth, which can include
* a throbbing feeling in the stomach area.
* deep pain in the back or side of the stomach area.
* steady, gnawing pain in the stomach area that lasts for hours or days.
* pain in the jaw, neck, back, or chest.
* coughing or hoarseness.
* shortness of breath and trouble breathing or swallowing.
Nurses should teach all patients-whether they have been prescribed fluoroquinolones or not-to decrease their risk of developing an aortic aneurysm by eating a healthy diet, managing high blood pressure and cholesterol, and not smoking. All patients receiving fluoroquinolones should be taught to read the medication guide that comes with each filled prescription for the most current information about potential adverse effects. To read the FDA Drug Safety Communication on fluoroquinolone antibiotics, go to http://www.fda.gov/Drugs/DrugSafety/ucm628753.htm.