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.