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FDA Strengthens Warnings for Powerful Antibiotics


July 26, 2016 — The FDA has updated labels on some of the most powerful antibiotics to warn that the risk of disabling side effects outweighs their benefit for treating minor infections.

Warnings were issued for all antibiotics in the fluoroquinolone class, which includes Levaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin), Factive (gemifloxacin), and ofloxacin.

The FDA has already issued a number of warnings about severe side effects, beginning in 2008 when the agency added a “Black Box” warning label about tendonitis and tendon ruptures.

In August 2013, the FDA strengthened warnings about peripheral neuropathy, which is a type of nerve damage that can occur suddenly (within days or weeks) and cause permanent weakness or pain.

These side effects can involve tendons, muscles, joints, nerves, and the central nervous system (confusion and hallucinations). Multiple side effects may occur at the same time.

The FDA says fluoroquinolones should not be prescribed for less serious infections unless there is no alternative. They should not be prescribed to most patients with:

  • Acute bacterial sinusitis
  • Acute exacerbation of chronic bronchitis
  • Uncomplicated urinary tract infections

The announcement comes two months after the FDA restricted the use of these antibiotics for patients with uncomplicated infections. Fluoroquinolones are some of the most powerful antibiotics on the market. Prescribing them when a safer antibiotic would work contributes to antibiotic resistance and exposes the patient to unnecessary risks.

Drug-makers are facing a growing number of lawsuits from people with severe nerve damage. Furthermore, the manufacturers of Levaquin are facing approximately 400 lawsuits in a federal Multi-District Litigation (MDL No. 2642) in Minnesota for allegedly downplaying the risk of tendon ruptures.

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