FDA issues fluoroquinolone black-box warning

November 2016 - Vol. 35, No. 10

On July 8, the Food and Drug Administration notified the manufacturers of fluoroquinolone antimicrobials that black-box warnings must be added to the drugs’ labels to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection.

The Otolaryngology–Head and Neck Surgery journal’s Clinical Practice Guideline: Adult Sinusitis includes the following paragraph as part of key action statement five related to “choice of antibiotic for acute bacterial rhinosinusitis” (page S17).

Penicillin-allergic patients

For penicillin-allergic patients, either doxycycline or a respiratory fluoroquinolone (levofloxacin or moxifloxacin) is recommended as an alternative agent for empiric antimicrobial therapy. Fluoroquinolones, however, are not recommended for first-line therapy of ABRS in patients without penicillin allergy because outcomes are comparable to amoxicillin- clavulanate, and adverse events are higher in some trials.126 Combination therapy with clindamycin plus a third-generation oral cephalosporin (cefixime or cefpodoxime) is recommended in adults with a history of non–type I hypersensitivity to penicillin.