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Medication Safety Alerts

Fluoroquinolone Antibacterial Drugs MedWatch


On May 12, 2016, the United States Food and Drug Administration (FDA) issued a MedWatch advising that there is a risk of serious side effects for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who use fluoroquinolone antibacterial drugs. Patients with these conditions should only use a fluoroquinolone if there are no other 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. This advisory affects tablets, capsules, and injectable dosage forms.

The FDA recommends that plan members should contact their doctor immediately if they experience any serious side effects while taking their 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. Members should talk with their doctor if they have any questions or concerns.

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.

If you are currently taking fluoroquinolone antibacterial drugs and have questions, please call your doctor or call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit

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