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Even More Bad News for Fluoroquinolones

While the mechanism is not yet understood, the risk for aortic aneurysm rupture or dissection appears to be approximately doubled in patients using quinolones.  Therefore, FDA is requiring that warnings be added to the prescribing information for fluoroquinolones as well as their associated medication guides which state that they should be avoided in patients who have or are at risk for aortic aneurysm, including those with peripheral vascular disease, hypertension, Marfan syndrome, Ehlers-Danlos syndrome, and the elderly. 

These new concerns join the growing ranks of other concerning adverse effects associated with quinolone use:

● Hypoglycemic coma (even in non-diabetics)

● Risk appears to be greatest with renal impairment, advancing age and/or concurrent use of hypoglycemic medications

● CNS effects, including attention disturbances, memory impairment, delirium, nervousness, agitation and disorientation

● May occur with as little as a single dose

● Muscle, tendon, joint or nerve damage

● Peripheral neuropathy

● QT prolongation

As such, providers are reminded that quinolones should be avoided for the following unless no acceptable alternatives exist:

● Acute bacterial sinusitis

● Amoxicillin-clavulanate is preferred by the Infectious Diseases Society of America (IDSA)

● Acute exacerbations of chronic bronchitis

● High-dose amoxicillin, amoxicillin-clavulanate and macrolide antibiotics are alternatives

● Uncomplicated urinary tract infections

● Instead, IDSA recommends amoxicillin-clavulanate, TMP/SMX or nitrofurantoin

References:
● Food and Drug Administration.  Safety Announcement:  FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients. December 10, 2018.  Accessed February 11, 2019.

● Anthony W. Chow, Michael S. Benninger, Itzhak Brook, Jan L. Brozek, Ellie J. C. Goldstein, Lauri A. Hicks, George A. Pankey, Mitchel Seleznick, Gregory Volturo, Ellen R. Wald, Thomas M. File; IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults, Clinical Infectious Diseases, Volume 54, Issue 8, 15 April 2012, Pages e72–e112, https://doi.org/10.1093/cid/cis370.  Accessed February 11, 2019.

● Kalpana Gupta, Thomas M. Hooton, Kurt G. Naber, Björn Wullt, Richard Colgan, Loren G. Miller, Gregory J. Moran, Lindsay E. Nicolle, Raul Raz, Anthony J. Schaeffer, David E. Soper; International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases, Clinical Infectious Diseases, Volume 52, Issue 5, 1 March 2011, Pages e103–e120, https://doi.org/10.1093/cid/ciq257.  Accessed February 11, 2019.   

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February 20, 2019
 




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