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FDA Calls for Stronger Warnings on Certain Antibiotic Labels.

The US Food and Drug Administration is requiring labeling changes to clarify the risk of mental health side effects of fluoroquinolones, a class of antibiotics that includes levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive), delafloxacin (Baxdela), and more than 60 generic versions. Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections and have been used for more than 30 years. The mental health side effects to be included in the labeling are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium. This new label change will require that the mental health side effects be listed separately from other central nervous system side effects and be consistent across all fluoroquinolone labels. The FDA also ruled that the Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones will now be required to explicitly note the potential risk of coma with hypoglycemia.

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Title Annotation:NEWSBRIEFS
Publication:Duke Medicine Health News
Date:Sep 1, 2018
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