FDA Advises Restricting Use of Fluoroquinolone Antibacterial Therapies

May 13, 2016
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.