FDA
25th January 2016

FDA Panel Does Not Support Current Labeling of Fluoroquinolones

On November 4th, the Antimicrobial Drugs Advisory Committee (ADAMC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) convened to discuss the current indications for fluoroquinolone (FQ) antibiotics. 

FDA Panel Does Not Support Current Labeling of Fluoroquinolones

On November 4th, the Antimicrobial Drugs Advisory Committee (ADAMC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) convened to discuss the current indications for fluoroquinolone (FQ) antibiotics.

The panels unanimously agreed that data on the risks and benefits of fluoroquinolone antibiotic drugs does not support their use in the treatment of acute bacterial sinusitis. The panels also voted (20 no, 1 yes) that current data on the risks and benefits for treating uncomplicated urinary tract infections was insufficient. Similarly, the panel agreed that data was insufficient to support the use of fluoroquinolones in the treatment of acute bacterial exacerbation of chronic bronchitis in those with chronic obstructive pulmonary disease (18 no, 2 yes, 1 abstention).While fluoroquinolones are currently approved for these indications, the panel, along with over 30 open public hearing speakers voiced the need for stronger labels on these indications due to the serious adverse events associated with their use. These serious adverse events include, tendinitis, tendon rupture, central nervous system effects, peripheral neuropathy and certain cardiovascular effects (i.e. QT prolongation).

“Very rare side effects will be magnified when we abuse an antibiotic millions of times,” stated panelist Antonio Carlos Arrieta, MD, division chief, Division of Infectious Diseases, Children’s Hospital of Orange County, Orange, California.

“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,” added panelist Tobias Gerhard, PhD, of Rutgers University in New Brunswick, N.J.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

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