Antibiotic Use Restricted for Specific Infections; Side Effects

On May 12, 2016, the FDA advised that 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. Fluoroquinolone should be reserved for patients who do not have alternative treatment options.


An FDA safety review has shown that fluoroquinolones when used systemically (i.e. 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, the 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.


Patients should 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 their health care professional about 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. Currently available FDA-approved fluoroquinolones for systemic use include Avelox (Moxifloxacin), Cipro (Ciprofloxacin), Factive (Gemifloxacin), Levaquin (Levofloxacin), Moxifloxacin Injection, and Ofloxacin.


The FDA previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008. The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.


See the FDA Drug Safety Communication


Also see the FDA Antimicrobial Drugs Advisory Committee 2015 Meeting Materials


Also see the August 2013 FDA Drug Safety Communication


Also see the July 2008 FDA Postmarket Drug Safety Information for Patients and Providers


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication