Regulatory Focus™ > News Articles > FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases

FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases

Posted 12 May 2016 | By Zachary Brennan 

FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases

The US Food and Drug Administration (FDA) on Thursday advised that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections (UTIs) who have other treatment options.

“For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options,” the agency said in its safety notification.

When used systemically (i.e. tablets, capsules and injectable), an FDA safety review found that fluoroquinolones are associated with disabling and potentially permanent serious side effects involving the tendons, muscles, joints, nerves and central nervous system. The drugs impacted by the notification include:

Brand Name

Active Ingredient

Avelox

Moxifloxacin+

Cipro

Ciprofloxacin+

Cipro extended-release*

Ciprofloxacin extended-release+

Factive

Gemifloxacin+

Levaquin

Levofloxacin+

Moxifloxacin Injection

Moxifloxacin

Ofloxacin*

Ofloxacin+

+ available as generic
* available only as generic

FDA is also now requiring the drug labels include an updated boxed warning and that medication guides reflect this new safety information. 

The notice follows the release of previous safety warnings from FDA associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008. The safety issues were also discussed at an FDA advisory committee meeting in 2015.

FDA Drug Safety Communication

 


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