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FDA is strengthening the warnings in the product labeling and Medication Guides for systemic (oral or injectable) fluoroquinolones regarding blood sugar and mental health effects. Fluoroquinolones are a class of antibiotics used to treat specific types of bacterial infections. Currently available systemic fluoroquinolones include ciprofloxacin, delafloxacin, gemifloxacin, levofloxacin, moxifloxacin, and ofloxacin. All fluoroquinolones are associated with a risk of mental health effects, including agitation, delirium, disorientation, disturbances in attention, memory impairment, and nervousness. While blood sugar effects were previously known, current evidence demonstrates a risk for severe hypoglycemia potentially leading to fatal coma. Both of these effects may be disabling and irreversible and can occur following a single dose of a systemic fluoroquinolone. FDA previously issued safety alerts for systemic fluoroquinolones for musculoskeletal and nervous system side effects (2016), potential neuropathy (2013), and tendon rupture and tendonitis (2008).
The product labeling for all systemic fluoroquinolones will be updated to include these expanded warnings. FDA highly discourages the use of systemic fluoroquinolones for treating bacterial sinusitis, bronchitis, and uncomplicated urinary tract infections, unless there are no alternative treatment options. Use caution when prescribing fluoroquinolones to patients with a history of diabetes or hypoglycemia. Severe hypoglycemia is more commonly seen in the elderly and in patients taking oral hypoglycemic or insulin therapy, but it may occur in the absence of predisposing risk factors. Educate and monitor patients using fluoroquinolones for signs and symptoms of hypoglycemia, and discuss hypoglycemia management. Discontinue and avoid further use of systemic fluoroquinolones in patients who report blood sugar or mental health effects. Advise patients to contact their health care professional if they experience signs or symptoms of hypoglycemia (eg, confusion, dizziness, feeling shaky) or mental health effects associated with systemic fluoroquinolone use.
More information can be found in the following links:
- FDA MedWatch Alert – July 10, 2018
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm - FDA Drug Safety Communication – July 10, 2018
www.fda.gov/Drugs/DrugSafety/ucm611032.htm - FDA MedWatch Alert – July 26, 2016
www.fda.gov/Drugs/DrugSafety/ucm500143.htm - FDA Drug Safety Communication – July 26, 2016
www.fda.gov/Drugs/DrugSafety/ucm511530.htm - FDA Drug Safety Communication – May 12, 2016
www.fda.gov/Drugs/DrugSafety/ucm500143.htm