Dear VEP Providers,

This is a reminder and an update regarding the FDA position on the use of fluoroquinolone antibiotics (Levaquin, Cipro, others). The FDA position is that the risks of fluoroquinolones outweigh the benefits for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or uncomplicated UTI. The FDA advises to not use fluoroquinolones for these conditions unless there are no alternative treatment options.

Below are excerpts from the latest FDA warning and here is the link:
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm513183.htm

Robert Wyman, MD | Vice President of Quality
Tel: 925-482-2802 | Fax: 925-482-2838
rwyman@vephealthcare.com

 

FDA Warning Released on July 26, 2016: The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

An FDA safety review found that both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.

Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA has determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options. For some serious bacterial infections, including anthrax, plague and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin) and gemifloxacin (Factive).

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