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FDA Boxed Warning Required for Fluoroquinolones

April 13, 2017

On May 12, 2016, the FDA released an announcement advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute 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.

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. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

According to the FDA, healthcare 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 FDA is requiring product labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated. The FDA states that to minimize the risk “The BOXED WARNING must include the statement to reserve [TRADENAME] for use in patients who have no alternative treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections.”

Link to official FDA announcement: www.fda.gov/Drugs/DrugSafety/ucm500143.htm

Adverse outcomes from fluoroquinolone use have spawned numerous class action lawsuits but few prescribers are co-defendants in these types of cases. We caution that this new guidance could expose prescribers to increased liability in future cases, and urge them to understand this warning and document diagnoses, indications, and appropriateness for fluoroquinolone use.

Created by MagMutual from materials provided by COPIC as part of MagMutual and COPIC’s alliance to improve patient safety and quality of care for all of our PolicyOwners.

Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This article has been written as an aid to you in your practice. The ultimate decision on how to use the information provided within this article rests solely with you, the PolicyOwner.

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