(Reaffirmed September 2022)
(Replaces July 20, 2018, ACOG Practice Advisory, “New FDA Safety Warning for Fluoroquinolone Antibiotics”)
The U.S. Food and Drug Administration (FDA) has updated its drug safety information for oral and injectable fluoroquinolone antibiotics to include the rare but serious risk of aortic ruptures or tears in certain patients 1. The FDA advises that health care providers should not prescribe systemic fluoroquinolones for patients who have an aortic aneurysm or are at risk of an aortic aneurysm (such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients) unless no other treatments are available 1. This updated warning will be added to the prescribing information and patient medication guide for all fluoroquinolones for systemic use.
This latest safety communication reinforces existing guidance from the FDA, which advises against prescribing systemic fluoroquinolones to patients who have other treatment options for bacterial infections, including uncomplicated urinary tract infections, because the risks outweigh the benefits in these patients 2. Potential risks associated with fluoroquinolone use include hypoglycemic coma and certain adverse mental health effects 3; disabling and potentially permanent adverse effects to the tendons, muscles, joints, nerves, and central nervous system 4; peripheral neuropathy 4; and tendinitis and tendon rupture 4.
The FDA is continuing to assess safety issues with fluoroquinolones as part of its ongoing review of drugs and will provide updates if additional actions are needed. See the FDA’s Fluoroquinolone Antimicrobial Drugs Information page for more information 5.
A Practice Advisory is issued when information on an emergent clinical issue (e.g. clinical study, scientific report, draft regulation) is released that requires an immediate or rapid response, particularly if it is anticipated that it will generate a multitude of inquiries. A Practice Advisory is a brief, focused statement issued within 24-48 hours of the release of this evolving information and constitutes ACOG clinical guidance. A Practice Advisory is issued only on-line for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal or incorporation into other ACOG guidelines.
This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on www.acog.org or by calling the ACOG Resource Center.
While ACOG makes every effort to present accurate and reliable information, this publication is provided “as is” without any warranty of accuracy, reliability, or otherwise, either express or implied. ACOG does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither ACOG nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with this publication or reliance on the information presented.
Publications of the American College of Obstetrician and Gynecologists are protected by copyright and all rights are reserved. The College's publications may not be reproduced in any form or by any means without written permission from the copyright owner.
The American College of Obstetricians and Gynecologists (ACOG), is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 58,000 members, ACOG strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women's health care. www.acog.org
