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Medication Safety Alerts

Fluoroquinolone Black Box Warning Revisions

07/26/2016

On July 26, 2016, the United States Food and Drug Administration (FDA) announce changes to the labels of fluoroquinolone antibacterial drugs. The labels were changed to let doctors know about disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur with these products.

Fluoroquinolones are available under the brand names Avelox®, Cipro®, Cipro Extended-Release, Factive, Levaquinand the generic names moxifloxacin, ciprofloxacin, ciprofloxacin extended-release, gemifloxacin, levofloxacin and ofloxacin. This affects tablets, capsules, and injectable dosage forms.

The FDA has provided the following information for members.

  • Fluoroquinolone antibiotic medicines are associated with disabling and potentially permanent serious side effects that can occur together in the same patient and should not be used to treat certain uncomplicated infections.
  • These uncomplicated infections include acute bacterial sinusitis (ABS), acute worsening of bacterial chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI).
  • These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, and can occur within hours to weeks after starting a fluoroquinolone medicine.
  • FDA has updated the Boxed Warning in the labels, added new warnings, and has revised the patient Medication Guide of all fluoroquinolone antibiotics.
  • Contact your doctor immediately if you experience any serious side effects while you are taking your fluoroquinolone medicine.
  • Before starting a new fluoroquinolone medicine, inform your doctor if you have previously experienced any serious side effects with another antibiotic.

Serious side effects involving the tendons, muscles, joints and nerves include:

  • Swelling or inflammation of the tendons
  • Tendon rupture
  • Tingling or pricking sensation (“pins and needles”)
  • Numbness in arms or legs
  • Muscle pain
  • Muscle weakness
  • Joint pain
  • Joint swelling

Serious central nervous system side effects include:

  • Depression
  • Hallucinations
  • Suicidal thoughts
  • Confusion
  • Anxiety

Other side effects include:

  • Abnormally rapid or irregular heart beat
  • Ringing or buzzing in the ears
  • Vision problems
  • Skin rash
  • Sensitivity of skin to sunlight
  • Headache
  • Trouble falling asleep
  • Fatigue
  • Read the patient Medication Guide you receive with your fluoroquinolone antibiotic prescriptions, which explains the benefits and risks of the medicine.
  • Talk to your doctor if you have questions or concerns about fluoroquinolone antibiotic medicines.
  • We communicated safety information associated with fluoroquinolones in May 2016, August 2013, and July 2008.
  • Report side effects from a fluoroquinolone or any drug to your doctor and the FDA.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is sending letters to doctors whose patients have received prescriptions for fluoroquinolone antibacterial drugs. For more information, please call a Customer Care representative toll-free at 1-866-823-5184.

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 http://www.fda.gov .

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