FDA Changes Warning For Fluoroquinolones

Searcy Denney Scarola Barnhart & Shipley
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Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs:

  • Avelox (moxifloxacin);
  • Cipro (ciprofloxacin);
  • Cipro extended-release (Cirpofloxacin extended- release);
  • Factive (gemiflozacin);
  • Levaquin (levoflozacin); and
  • Ofloxacin ( Generic Brand).

The Food and Drug Administration (“FDA”) says it has revised the boxed warning for Fluoroquinolones antibacterial drugs for systemic use to set forth the drugs should be reserved for patients who have no other treatment options for:

  • Acute bacterial sinusitis;
  • Acute exacerbation of chronic bronchitis; and
  • Uncomplicated urinary tract infections because the risk of these serious side effects outweighs the benefits in those patients.

In a July 26, 2016 Safety Alert, the FDA noted that Fluoroquinolones are associated with disabling and potentially permanent side effects to the following parts of the body:

  • Central nervous system
  • Joints
  • Muscles
  • Nerve
  • Tendons

The FDA stated:

“After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experience disabling and potentially permanent side effects involving two or more body system after being treated with a systemic fluoroquinolone.”

The FDA further states, “Health care professionals should not prescribe who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients.”

The FDA noted to health care providers to “stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.”

The positives and negatives of fluoroquinolones are a serious and difficult decision by healthcare providers. Some of the conditions that can call for aggressive treatment with fluoroquinolone can get out of control without them. This requires careful monitoring and education by healthcare professionals to be sure patients do not begin to demonstrate symptoms of severe complications.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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