You are currently viewing FDA Calls for More Restrictions on Fluoroquinolone Use

Kristin J. Kelley, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The risks for “disabling and potentially permanent” side effects associated with systemic fluoroquinolone antibacterials (e.g., ciprofloxacin, moxifloxacin) generally outweigh the benefits in patients with sinusitis, bronchitis, and uncomplicated urinary tract infections, the FDA warned late last week. Fluoroquinolones should only be used for these indications when patients don’t have other treatment options, the agency said.

Side effects can compromise the nerves, central nervous system, tendons, muscles, and joints. Symptoms may include confusion; hallucinations; joint, muscle, and tendon pain; or a tingling sensation (i.e., “pins and needles”).

The action follows advisory panel recommendations made in late 2015 for stronger label warnings. The labels were previously updated in 2013 to warn of increased risk for peripheral neuropathy. Additionally, in 2008, a boxed warning was added to note risks for tendinitis and tendon rupture.

See the linked FDA drug safety communication for a full list of fluoroquinolones currently approved for systemic use.

Personal comment: This is once again a reason why doctors need to have a resource they can quickly get to, that tells them what the simplest antibiotic is for the given illness. If Ceforal will work, use it. In such a case, there would be NO reason to use CIPRO.


FDA MedWatch safety alert (Free)

FDA drug safety communication (Free)

FDA briefing document on benefits and risks of systemic fluoroquinolones (Free PDF) Background: Physician’s First Watch coverage of 2015 advisory panel vote (Free)