FDA Approves Safety Labeling Changes for Fluoroquinolones

FDA Approves Safety Labeling Changes for Fluoroquinolones

Posted By Maher Law Firm || 26-Jul-2016

The U.S. Food and Drug Administration (FDA) has approved new safety labeling changes for a class of antibiotics called fluoroquinolones in order to enhance existing warnings about their link with a number of serious and potentially permanent side effects. The purpose of these antibiotics is to treat bacterial infection by killing bacteria or stopping its growth. While effective in this capacity, many people have reported that both the injectable and oral versions of the drug have caused severe side effects related to the central nervous system, muscles, joints, and tendons. These effects can manifest either hours or weeks after exposure, and could cause permanent injury.

FDA-approved fluoroquinolones include gemifloxacin (Factive), ofloxacin, moxifloxacin (Avelox), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, and levofloxacin (Levaquin). The labeling changes include an updated Boxed Warning as well as revisions to the Warnings and Precautions section, which includes information about the risk of the aforementioned disabling and potentially irreversible side effects. The label also contains new limitation-of-use statements advising doctors to reserve this class of antibiotics only for patients who have no other options for treatment for the following conditions:

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

The FDA has determined that the risk of complications far outweighs the benefits of this drug for patients with these conditions. The FDA thus advises that doctors only prescribe this medication as a last resort for these patients when no other treatment options are available. However, for patients with certain serious bacterial infections, including bacterial pneumonia, plague, and anthrax, fluoroquinolones are still approved as an appropriate therapeutic option.

Visit the FDA website to view the full press release: FDA updates warnings for fluoroquinolone antibiotics.

Dangerous Drug Attorneys Accepting Cases Nationwide

If you have suffered serious or permanent injury after taking a fluoroquinolone drug, you should consult with an Orlando dangerous drug attorney at The Maher Law Firm. Recommended by clients for more than 40 years, our firm has extensive experience handling dangerous drug cases, and is committed to pursuing maximum compensation for our clients. You should not have to suffer the financial consequences for using a drug you were led to believe was safe!

We are prepared to offer you a free case evaluation to discuss your potential case. To request yours, please call (855) 338-0720.

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