FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
Safety Announcement
The U.S. Food and Drug Administration is advising 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. For patients with these conditions, fluoroquinolone should be reserved for those 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, 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 (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).
We 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.
We urge patients and health care professionals to report side effects involving fluoroquinolone antibacterial drugs and other drugs to the FDA MedWatch program
Questions?
If you can't find an answer, please feel free to contact our Customer Service Customer Service Customer Service
Questions?
If you can't find an answer, please feel free to contact our Customer Service
Employer web tools
Benefit Tracker
Check benefits, eligibility, incentive and utilization
Producer web tools
- Fully Insured Quotes (1-50)
- Equal Funding Quotes (25-99)
- Corporate reports
- eCommissions
Hello.
We have exciting news to share. ODS is changing its name to Moda Health.
Moda comes from the latin term "modus" and means "a way". We picked it because that's what we are here to do: help our communities find a way to better health.
Together, we can be more, be better.
Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:
Hello.
Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:
Changing your location to Oregon
You can return to your previous location in the site header.