FDA Drug Safety Podcast: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On July 10, 2018, FDA announced it is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. The low blood sugar levels can result in serious problems, including coma, particularly in older people and patients with diabetes who are taking medicines to reduce blood sugar. We are making these changes because our recent review found reports of life-threatening low blood sugar side effects and reports of additional mental health side effects.

We are requiring these updates in the drug labels and to the patient Medication Guides for the entire class of fluoroquinolones. This affects only the oral or injectable fluoroquinolone formulations. Blood sugar disturbances, including high blood sugar and low blood sugar, are already included as a warning in most fluoroquinolone drug labels; however, we are adding that low blood sugar levels, or hypoglycemia, can lead to coma.

A range of mental health side effects are already described in the Warnings and Precautions section of the fluoroquinolone drug labels. The new label changes will make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. Mental health side effects to be added are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium.

Health care professionals should alert patients to the symptoms of hypoglycemia and inform them about the risk of psychiatric adverse reactions that can occur after just one dose. Stop fluoroquinolone treatment immediately if a patient reports any central nervous system side effects, or blood glucose disturbances. Health care professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, as the risks outweigh the benefits in these patients.

FDA monitors and evaluates the safety and effectiveness of medicines and reviewed reports of cases submitted to FDA’s Adverse Event Reporting System and in the published medical literature, of apparently healthy patients experiencing serious changes in mood, behavior, and blood sugar levels while being treated with systemic fluoroquinolones.

Side effects involving fluoroquinolones should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info

. Thanks for listening.

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FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes

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