The US Food and Drug Administration (FDA) has issued new restrictions and label warnings for the category of antibiotics called fluoroquinolones. According to the advisory, side effects outweigh benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.

Those having these conditions should reserve fluoroquinolones for cases in which there are no alternative treatment options, says the FDA.

An FDA safety review demonstrated that fluoroquinolones, when used in tablets, capsules, and injectable form, are linked with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. The FDA continues to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Fluoroquinolones are broad-spectrum antibiotics, effective for both gram-negative and gram-positive bacteria, that play an important role in treatment of serious bacterial infections, especially hospital-acquired infections and others in which resistance to older antibacterial classes is suspected.

Currently Available FDA-Approved Fluoroquinolone Antibacterial Drugs:

Brand Name (Active Ingredient)

  • Avelox (Moxifloxacin)

  • Cipro (Ciprofloxacin)

  • Cipro extended-release (Ciprofloxacin extended-release)

  • Factive (Gemifloxacin)

  • Levaquin (Levofloxacin)

  • Moxifloxacin Injection (Moxifloxacin)

  • Ofloxacin (Ofloxacin)

Because the use of broad-spectrum antibiotics encourages the spread of multidrug-resistant strains and the development of Clostridium difficile infections, treatment guidelines from the Infectious Diseases Society of America, the American Thoracic Society, and now the FDA, recommend minimizing the use of fluoroquinolones and other broad-spectrum antibiotics in less severe infections and in those in which risk factors for multidrug resistance are not present.

Quinolones are also contraindicated if a patient has epilepsy, QT prolongation, pre-existing CNS lesions, or CNS inflammation, or the patient has suffered a stroke.

THe FDA recommends patients contact their health care professional immediately if they experience any serious side effects while taking fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with a health care professional if they have any questions or concerns.

Image: Structure of bacterial DNA gyrase complexed with DNA and two ciprofloxacin molecules (green). By Fdardel CC BY-SA 3.0.

For future updates, subscribe via Newsletter here or Twitter