|Articles|May 13, 2016

FDA Advises Restricting Use of Fluoroquinolone Antibacterial Therapies

Author(s)Sarah Anwar

For patients who suffer from certain uncomplicated infections such as, sinusitis, bronchitis, and uncomplicated urinary tract infections, the health risks associated with fluoroquinolone far outweigh the benefits.

The US Food and Drug Administration (FDA) recently issued a statement advising healthcare providers not to prescribe fluoroquinolone antibacterial drugs to individuals who suffer from certain uncomplicated infections such as sinusitis, bronchitis, and uncomplicated urinary tract infections, due to serious, disabling side effects that can be permanent with consistent use. The FDA notes that the health risks associated with this treatment far outweigh the benefits. Fluoroquinolone antibacterial drugs should only be prescribed to those patients who have no alternative treatment options.

The regular use of fluoroquinolone antibacterial drugs can affect tendons, muscles, joints, nerves, and the central nervous system. Some patients may experience a “‘pins and needles’ tingling or pricking sensation,” hallucinations, or even confusion.

As a result, the FDA will now require all pharmaceutical companies to update the drug labels and Medication Guides for all antibacterial drugs containing fluoroquinolone to reflect these findings. There are still ongoing investigations regarding fluoroquinolone antibacterial drugs, and the FDA will continue to update the public with any additional information as it becomes available.

Patients are advised to contact their healthcare providers if they experience any serious side effects that may be related to the use of fluoroquinolone treatment. Healthcare providers are advised to “switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.”

The FDA encourages healthcare professionals to report all adverse events associated with fluoroquinolone treatments to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


Related to this article

This Week's Top 5 Infectious Disease News Stories: September 12-September 18, 2026
In this week's top infectious disease stories, a Pennsylvania teen became the state's fourth measles death in weeks, the CDC reported a 17% summer surge in rabies exposure calls, new research revisited whether cefepime raises mortality risk, a multihospital review examined ceftriaxone's safety after state alerts, and examining Legionella pneumonia diagnostics.
Ceftriaxone Safety: Separating Signal From Risk
A retrospective multihospital study found that severe adverse events occurred at similarly low rates with ceftriaxone and other IV cephalosporins suggesting there is no evidence to support avoiding ceftriaxone despite recent health department safety alerts.
Treatment of Latent Tuberculosis in a Trice
A retrospective study of 225 patients across Cook County Department of Health clinics found that the novel 1-month 1HP regimen (isoniazid plus rifapentine) for latent TB infection had a completion rate comparable to standard longer regimens and was well tolerated, suggesting it may be a viable shorter alternative.
Drawing Borders Around a Borderless Specialty
Editor in chief Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, discusses the proposed OMB rule restricting federal grants for international research collaboration, and how it threatens infectious disease medicine's inherently borderless surveillance networks, publication access, and knowledge-sharing systems.
Beyond Approval: Finding the Right Place for Emerging Gram-Negative Antibiotics
The expanding gram-negative antibiotic pipeline offers important new treatment options; however, FDA approval alone does not define a drug’s place in therapy. Clinicians must weigh the clinical problems that each agent solves, the strength of the evidence behind it, and what remains unknown before incorporating these therapies into routine practice.