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FDA Enhances Warnings on Group of Strong Antibiotics


The U.S. Food and Drug Administration has issued enhanced warnings on a group of strong antibiotics, Reuters reports.

About the Antibiotic Warnings

The U.S. Food and Drug Administration (FDA) has enhanced warnings of side effects of a group of strong antibiotics used to treat a variety of respiratory and urinary tract infections and limited their use to patients with no alternatives.

The antibiotics known as fluoroquinolones include Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets and Merck Inc’s Avelox.

The FDA originally added a box warning to the antibiotics in July 2008 to inform users about the increased risk of tendinitis; however, the box warning was updated on Tuesday to highlight the disabling and potentially permanent side effects of the drugs.

The regulator said in May that the side effects of the antibiotics outweighed its benefits.

Major Side Effects of Levaquin, Cipro and Avelox

According to Drugwatch.com major side effects include:

  • Nerve damage
  • Stomach problems
  • Headaches
  • Skin rash
  • Seizures
  • Hallucinations
  • Tendon rupture
  • Abnormal heart rhythm

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