FDA to withdraw poultry drugs


ROCKVILLE, Md. – The Food and Drug Administration’s Center for Veterinary Medicine is withdrawing its approval of fluoroquinolone poultry antibiotics.

The ban affects the enrofloxacin drug, Baytril, manufactured by Bayer Corp. and used to control E. coli in chickens and turkeys, and Abbott Laboratories’ Sara Flox Injection, approved for E.coli organisms in chickens and turkeys.

The FDA has determined that use of these fluoroquinolones in poultry has caused the development of fluoroquinolone-resistant campylobacter, a pathogen to humans.

The agency also reported this fluoroquinolone-resistant campylobacter is transferred to humans and is a significant cause of the development of resistant campylobacter infections in humans.

Enrofloxacin belongs to the class of antimicrobial drugs called fluoroquinolones. Fluoroquinolones also are approved for use in humans, and they are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their spectrum of activity, safety, and ease of administration.

This class of drugs is effective against a wide range of human diseases and is used to treat bacterial infections in the community and in hospitals.

Fluoroquinolones are used routinely by physicians for the treatment of foodborne disease.

FDA approved the fluoroquinolones for use in poultry in 1995 and 1996. At the time of approval, the center instituted several strategies intended to prevent or mitigate the development of resistance. However, resistance developed to the fluoroquinolones in campylobacter, a major foodborne pathogen in humans.

Fluoroquinolones have been available for human use since 1986 and are commonly prescribed for persons with gastrointestinal illness. Yet resistance to fluoroquinolones did not increase among campylobacter organisms until 1996 and 1997, soon after the approval and use of these drugs in poultry.


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