The FDA stated that all fluoroquinolone antibiotics already included a range of mental health adverse effects described in the Warnings and Precautions section of the drug labeling, but have differed by individual drug.
Now, the FDA is requiring mental health adverse effects to be listed separately from the other central nervous system adverse effects, and be consistent across the labeling of all fluoroquinolone antibiotics. The mental health adverse effects to be included in the updated labeling are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium.
The updates apply to the drug labels and the patient medication guides for the entire class of fluoroquinolones, which affect only the fluoroquinolone formulations taken by mouth or given by injection.
According to an FDA drug safety communication, the new label changes “will make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class.”
FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive), and delafloxacin (Baxdela).
Additionally, the labeling must also be updated to include risks related to hypoglycemia. Based on a previous review that found instances of hypoglycemic coma in users of fluoroquinolones, the FDA is requiring that the Blood Glucose Disturbances subsection of the labeling be updated to explicitly reflect the potential risk of coma with hypoglycemia.
The FDA urges health care professionals to be aware of the potential risk of hypoglycemia sometimes resulting in coma, which can occur in elderly patients and those with diabetes taking an oral hypoglycemic medicine or insulin.
FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612995.htm?utm_campaign=07102018_PR_FDA%20updates%20warnings%20for%20fluoroquinolone%20risks&utm_medium=email&utm_source=Eloqua. Accessed July 10, 2018.
FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes [safety announcement]. FDA’s website. https://www.fda.gov/Drugs/DrugSafety/ucm611032.htm. Accessed July 10, 2018.