FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On April 4, 2017, CDER’s Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: Fluoroquinolone Safety Labeling Updates. This webinar discussed the July 2016 FDA approved labeling changes to the systemic fluoroquinolone antibacterial drugs. FDA found the certain serious musculoskeletal and central nervous system adverse reactions can be permanent and can occur together in the same patient. FDA re-evaluated the benefits and risks of fluoroquinolones for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (uUTI). The new labeling changes describe the disabling and potentially irreversible serious adverse reactions as Boxed Warnings and new Warnings and Precautions, and to reserve fluoroquinolones for treatment of ABS, ABECB, and uUTI for patients who have no other treatment options.

View Presentation: DDI Webinar – Fluoroquinolone 4/4/17

Download Presentation Slides: Fluoroquinolone Safety Labeling Updates (PDF – 1 MB)

Activity Outline and Continuing Education Information: Fluoroquinolone Safety Labeling Updates (PDF – 47 KB)

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communications issued May 12, 2016, and July 26, 2016.

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