Practice Advisory: FDA Issues Updated Fluoroquinolone Warning

The American College of Ob/Gyn 

The U.S. Food and Drug Administration (FDA) recently issued a Drug Safety Communication advising that oral and injectable fluoroquinolones should be reserved for use in patients who have no other treatment options for serious bacterial infections, including uncomplicated urinary tract infections, because the risks of serious adverse effects generally outweigh the benefits. The FDA has revised the current “Boxed Warning” on the labels of systemic fluoroquinolone antibacterial drugs to indicate that these medications are associated with disabling and potentially permanent adverse effects to the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. 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.

For more information on the updated fluoroquinolone warning, see the complete FDA Drug Safety Communication. For information and clinical guidance on the management of urinary tract infections, see the American College of Obstetricians and Gynecologists’ Practice Bulletin #91, "Treatment of Urinary Tract Infections in Nonpregnant Women." 

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 online 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 document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

 The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 57,000 members, The College 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. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization.

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