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Stronger Warnings for Antibiotics

  • June 1, 2016
  • RPh on the Go

antibiotic side effectsThe Food and Drug Administration recently issued a safety announcement to discuss the potentially serious side effects associated with certain antibacterial drugs. Fluoroquinolone is believed to have side effects which are severe enough that they should be avoided by patients who have other treatment options.


Fluoroquinolones are bacterial agents that work a broad range of pathogens. Tissue penetration, especially against intracellular compartments and respiratory secretions, makes it a desirable solution to many infections. The list of currently approved drugs in this class include:

• Avelox – active ingredient moxifloxacin
• Cipro – active ingredient ciprofloxacin
• Extended Release Cipro – active ingredient ciprofloxacin extended-release
• Factive – active ingredient gemifloxacin
• Levaquin – active ingredient levofloxacin
• Moxifloxacin Injection – Active ingredient moxifloxacin
• Ofloxacin – Active ingredient ofloxacin

Conditions most commonly treated by this class of drugs include urinary tract infections, bacterial bronchitis, sinusitis, pneumonia, bone and joint infections, skin and soft tissue infections, intraabdominal and septicemia infections, bacterial gastroenteritis, gynecological and urethral infections, typhoid fever, and pelvic inflammatory disease.

Side Effects

The side effects of these drugs have been under question for several years. In 2008, the FDA required providers notify patients of the increased possibility of developing tendon ruptures and tendinitis. There was found to be an increased risk for patients over the age of 60, and doctors were advised to tell patients to stop using the medications if there was any tendon swelling, inflammation, or pain. In 2013, the FDA required the labels for this class of drugs to include warnings for the potential nerve damage which could occur permanently soon after taking the medications. The latest labeling recommendations will include side effects that can affect the muscles, tendons, nerves, central nervous system, and joints. All of these symptoms are categorized under the term peripheral neuropathy and can include numbness, discomfort, weakness, tingling, burning, and pain in the affected areas.


Patients are encouraged to report any side effects immediately to their physician and to cease taking the medication if side effects occur. They are also urged to report their experience to the MedWatch program. It is important for patients to understand that, for some conditions, this class of drugs will be the best possible option. For most infections, however, other drugs have a lower associated risk of potentially serious and permanent side effects.

Physicians have been directed to limit prescribing fluoroquinolone treatments to patients who have other treatment options available, and to immediately find an alternative treatment for patients exhibiting any side effects. Pharmacists should be sure to discuss the new warnings and potential side effects with patients when dispensing the drugs, even if the patient has had the medication before.

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