The FDA has issued an advisory against the use of fluoroquinolone antibacterial drugs, such as Cipro or Avelox, for patients with certain respiratory or urinary tract infections.

“The serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options,” the FDA said in an advisory statement.

An FDA safety review has shown that fluoroquinolones when used systemically (ie tablets, capsules, and injectable) are associated 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, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Patients should contact your health care professional immediately if you experience any serious side effects while taking your 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 your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness. The following are currently available FDA-approved fluoroquinolones for systemic use:

Brand Name Active Ingredient
Avelox Moxifloxacin
Cipro Ciprofloxacin
Cipro extended-release Ciprofloxacin extended-release
Factive Gemifloxacin
Levaquin Levofloxacin
Moxifloxacin Injection Moxifloxacin
Ofloxacin Ofloxacin