Evidence Lacking for Some Antibiotic Use
Written by Editor   
Monday, November 30, 2015 09:00 AM

An FDA advisory panel has agreed overwhelmingly that evidence does not support some indications for systemic fluoroquinolone antibiotics.

Data on the risks and benefits of the drugs do not support their use in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients with COPD, or uncomplicated urinary tract infections.

The 21-member panel voted unanimously that support for fluoroquinolone use in acute bacterial sinusitis was lacking. On the bronchitis/COPD indication, the panel voted 18-2, with one abstention, that evidence was insufficient. And for uncomplicated urinary tract infections, the vote was 20-1.

What the FDA might do with the advice is uncertain, although the vote certainly raises the likelihood of new label language concerning use of fluoroquinolones for these indications, perhaps even revoking approval for these indications. 

The fluoroquinolones -- mainly ciprofloxacin, levofloxacin, and moxifloxacin -- have been indicated for some or all of the three disease entities for several years but there is rising concern that they are being used inappropriately, putting patients at risk for often serious side effects, the panel was told.

Physicians have long been aware of the class effects of the drugs, but physicians don't have "grave concerns" about the safety of the drugs, but they are concerned about over-use, which can lead to drug resistance, and inappropriate use for patients who don't need the medications.

"It was very apparent in the testimonials today that the current labeling does not communicate the risks clearly and that most if not all the patients that made statements today did not knowingly take on these risks."


Source: http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/54528