FDA approves safety labeling changes for fluoroquinolones
[7-26-16] Today, the FDA has approved labeling changes for antibacterial drugs called fluoroquinolones, including an updated Boxed Warning, and advising that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB) and uncomplicated urinary tract infections (UTIs) who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that oral and injectable fluoroquinolones for systemic use 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 required and approved label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.
The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients. The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.
July 26, 2016
- FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
- FDA Press Release: FDA updates warnings for fluoroquinolone antibiotics
Limits use for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections
May 12, 2016
- FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
- Example letter to fluoroquinolone application holder (PDF - 50 KB)
Because there are differences in the fluoroquinolones labels, FDA is posting an example sponsor letter that best captures the breadth of the announced safety labeling changes.
- FDA Response to Citizen Petition: Southern Network on Adverse Reactions (SONAR), Docket No. FDA-2014-P-0856. The Petition requests that FDA require changes in the professional labeling of Levaquin (levofloxacin) regarding “Potential Mitochondrial Toxicity”.