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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA to Hold Public Hearing on Proposal to Withdraw Poultry Enrofloxacin Approval

FDA Veterinarian Newsletter 2002 Volume XVII, No II

The Food and Drug Administration (FDA) will hold a hearing on the safety of enrofloxacin for use in poultry following CVM's proposal to withdraw approval for use of the product in poultry water. Enrofloxacin is in the class of antimicrobials known as fluoroquinolones; ciprofloxacin is the comparable human drug in this class. Baytril, the trade name of enrofloxacin, is indicated for the control, in chickens, of mortality associated with Escherichia coli (E.coli) and in turkeys, of mortality associated with E.coli and Pasterella multocida. Baytril is the product of Bayer Corp., Shawnee Mission, KS, which has requested the hearing.

The hearing will address CVM's determination that the use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistant Campylobacter species in poultry, that these fluoroquinolone-resistant organisms are transferred to humans and cause the development of fluoroquinolone-resistant Campylobacter in humans, and fluoroquinolone-resistant Campylobacter infections in humans are a health hazard. These determinations provided the basis for the Center's proposal in October 2000 to withdraw the approval for the animal drug use in poultry.

The supporting data for CVM's proposal includes:

  • an association between the approval of fluoroquinolones for use in poultry in the United States in October 1996 and an increase in fluoroquinolone-resistant Campylobacter infections in humans in the U.S.;
  • a comparison of fluoroquinolone use in poultry with other possible causes of fluoroquinolone-resistant infections; and
  • a risk assessment that determined that in 1999, an estimated 9,261 persons infected with campylobacteriosis and prescribed a fluoroquinolone in the United States had a fluoroquinolone-resistant illness due to the use of fluoroquinolones in chickens.

CVM has concluded that such patients, especially if they have underlying health problems, may suffer a prolonged illness or complications, and that therefore the approval for use of the drug in poultry should be withdrawn.

Additional information about the hearing is contained in a notice that appeared in the February 20, 2002, Federal Register or can be obtained from Robin Thomas Johnson, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.