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Jessica Hoerman
Jessica Hoerman
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Upcoming FDA Meeting Set to Review Fluoroquinolones

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A report recently released by the U.S. Food and Drug Administration (FDA) concludes that fluoroquinolones are no more effective at treating sinus infections, bronchitis in those with COPD, and urinary tract infections than a placebo and plans to review its findings at the agency’s November 5 meeting. The FDA also noted in the report that fluoroquinolones can cause a host of symptoms across multiple body systems that can lead to disability, which the FDA has named Fluorquinolones-associated disability (FQAD)

What are Fluoroquinolones?

Fluoroquinolones are a family of broad-spectrum antibiotics that have been widely used to a variety of infections, including:

  • Bacterial bronchitis
  • Pneumonia
  • Sinusitis
  • Urinary tract infections
  • Septicemia
  • Intra-abdominal infections
  • Joint and bone infections
  • Soft tissue and skin infections
  • Typhoid fever
  • Bacterial gastroenteritis
  • Urethral and gynecological infections
  • Pelvic inflammatory disease

The fluoroquinolones that are currently available in the U.S. include:

  • Ciprofloxacin (Cipro)
  • Gemifloxacin (Factive)
  • Levofloxacin (Levaquin)
  • Moxifloxacin (Avelox)
  • Norfloxacin (Noroxin)
  • Ofloxacin (Floxin)

According to the FDA committee report, fluoroquinolones have never been proven to be safe or effective in the treatment of sinusitis, bronchitis for those with COPD, or urinary tract infections, and no placebo-controlled studies were done in conjunction with approval of the medications, which was based heavily on the assumption that they were safe and effective. But fluoroquinolones have actually been shown to be quite unsafe, and there is significant evidence that they can lead to multiple musculo-skeletal and nervous system issues.

While side effects associated with a dangerous medication might be acceptable to some (as long as the medication is effective) fluoroquinolones have proven to be neither safe nor effective, causing many to wonder what, if any, value they may actually have.