FDA Puts Restrictions on Antibiotic Drug Class
Because the serious adverse effects associated with fluoroquinolone antibiotics generally outweigh the benefits of their use in treating sinusitis, bronchitis, and uncomplicated urinary tract infections, the Food and Drug Administration (FDA) is advising that these agents be reserved for patients who do not have alternative treatment options.
Systemic fluoroquinolones (eg, tablets, capsules, injectables) were linked to disabling and potentially permanent serious adverse events that can occur simultaneously, according to an FDA safety review. These effects may involve the tendons, muscles, joints, nerves, and central nervous system. Patients should report any serious side effects they experience during treatment, including tendon, joint, and muscle pain, a "pins and needles" tingling sensation, confusion, and hallucinations.
Healthcare professionals should immediately discontinue fluoroquinolone therapy if a patient reports serious adverse effects, and should prescribe a non-fluoroquinolone antibiotic to finish the patient's treatment course.
The FDA is requiring that all fluoroquinolone drug labeling and accompanying Medication Guides reflect this new safety information. Currently, the FDA-approved fluoroquinolone antibiotics for systemic use are:
— Avelox (moxifloxacin)
— Cipro (ciprofloxacin) and Cipro Extended-Release (ciprofloxacin extended-release)
— Factive (gemifloxacin)
— Levaquin (levofloxacin)
— Moxifloxacin Injection (moxifloxacin)
— Ofloxacin (ofloxacin)
The FDA will inform the public with updated information as it continues to investigate the safety issues with fluoroquinolones.
For more information visit FDA.gov.