Drug Safety Alerts

Fluoroquinolone Antibacterial Drugs MedWatch

05/12/2016


On May 12, 2016, the United States Food and Drug Administration (FDA) issued a MedWatch 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, fluoroquinolones should be reserved for those who do not have alternative treatment options.

Fluoroquinolones are available under the brand names Avelox^®, Cipro^®, Cipro Extended-Release, Factive^®, Levaquin^® and the generic names moxifloxacin, ciprofloxacin, ciprofloxacin extended-release, gemifloxacin, levofloxacin and ofloxacin.

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, the FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. The FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

The FDA recommends that health care providers 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.

CVS Caremark Response: There have been no recalls issued on these products by the manufacturers. CVS Caremark Mail Service Pharmacy will continue to dispense these products.

For more information about this issue, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/Safety.