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Practice Advisory: New FDA Safety Warning for Fluoroquinolone Antibiotics

(Replaces August 4, 2016, ACOG Practice Advisory, “FDA Issues Updated Fluoroquinolone Warning”)

On July 10, 2018, the U.S. Food and Drug Administration (FDA) issued a new Drug Safety Communication (1) regarding oral and injectable fluoroquinolone antibiotics and the potential risk of hypoglycemic coma and certain adverse mental health effects (ie, disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium). This latest FDA communication strengthens the Agency’s 2016 warning about oral and injectable fluoroquinolone antibiotics (2) and advises that health care professionals should not prescribe 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. Information about the potential for hypoglycemic coma and certain adverse mental health effects will be included in FDA-required updates to the drug labels and the patient medication guides for the entire class of fluoroquinolone antibiotics.

In 2016, the FDA issued a safety communication about oral and injectable fluoroquinolone antibiotics drugs and the risk of disabling and potentially permanent adverse effects to the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient (2). 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 (3). 

For clinical guidance on the management of urinary tract infections, see ACOG Practice Bulletin No. 91, Treatment of Urinary Tract Infections in Nonpregnant Women (4).

References
  1. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. Silver Spring (MD): FDA; 2018. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm611032.htm. Retrieved July 18, 2018.
  2. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. Silver Spring (MD): FDA; 2016. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm.  Retrieved July 18, 2018.
  3. U.S. Food and Drug Administration. Fluoroquinolone Antimicrobial Drugs Information. Silver Spring (MD): FDA; 2018. Available at: https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm346750.htm.  Retrieved July 18, 2018.
  4. Treatment of urinary tract infections in nonpregnant women. ACOG Practice Bulletin No. 91. American College of Obstetricians and Gynecologists. Obstet Gynecol 2008;111:785–94. 

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 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.

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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 
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