FDA warns about Cipro, other antibacterials

May 13, 2016

FDA issued a new warning about potentially serious side effects associated with fluoroquinolone antibacterial drugs. Affected brands include Cipro, Levaquin, Avelox, Factive and Moxaflaxacin injection, as well as the generic Ofloxacin.

FDA issued a new warning about potentially serious side effects associated with fluoroquinolone antibacterial drugs. Affected brands include Cipro, Levaquin, Avelox, Factive and Moxaflaxacin injection, as well as the generic Ofloxacin.

“FDA is 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,” FDA said in a MedWatch Safety Alert. “For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.”

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FDA’s safety review found 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,” FDA said.

FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.

Health care professionals 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. The symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion and hallucinations.

Related: FDA warns about Diflucan during pregnancy

FDA said it is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read more: FDA approves new antibacterial drug Avycaz