WASHINGTON (AP) – The Food and Drug Administration is banning the use of the antibiotic Baytril in poultry because of concerns the drug could lead to antibiotic-resistant infections in people.

The agency’s commissioner, Lester M. Crawford, on Thursday ordered that approval for use of the drug, known generically as enrofloxacin, be withdrawn effective Sept. 12.

Baytril is in the same family as the popular drug Cipro, which is used in humans.

Crawford cited particular concerns about campylobacter bacteria, a growing source of serious illness in humans.

Antibiotics used to treat it can be less effective if the germ has already developed resistance to Baytril, the FDA said.

Margaret Mellon, director of food and environment at the Union of Concerned Scientists, said the FDA’s move was “a big deal.”

“It’s the first time FDA has withdrawn a veterinary drug on the basis of antibiotic resistance concerns, fearing that use of the drug in animals is going to erode the effectiveness of the drugs in human medicine,” she said.

Dr. David Wallinga, director of the Antibiotic Resistance Project at the Institute for Agriculture and Trade Policy, praised the FDA “for acting decisively to protect the public’s health.”

Campylobacter is commonly found in the intestinal tracts of turkeys and chickens, where it does not generally cause illness, Crawford said in his order.

Use of enrofloxacin in poultry does not eliminate campylobacter from the birds, but instead results in the development of bacteria resistant to this type of drug, Crawford said.

Resistant bacteria may be present in poultry sold at retail outlets. Crawford noted that since the drug was introduced for poultry in the 1990s, the proportion of resistant campylobacter infections in humans has risen significantly.

That can prolong the length of infections in people and increase the risk of complications, Crawford said. Complications can include reactive arthritis and blood stream infections.

Dr. Stephen F Sundlof, director of FDA’s center for veterinary medicine, said Baytril will remain approved for use in infections in dogs and cats and for respiratory disease in cattle.

He said the decision was made to ban the drug in poultry but not cattle because chickens are a major source of campylobacter while cattle are not.

The FDA’s Center for Veterinary Medicine first proposed to pull the drug from use in chickens and turkeys in 2000, but the manufacturer, Bayer, asked for a hearing. Crawford acted after reviewing the results of that hearing.

Bayer has 60 days to appeal Crawford’s decision to a federal appeals court.

Bayer spokesman Bob Walker said the company was surprised and disappointed by the decision. He said officials are reviewing the decision from a scientific and legal position before deciding on further action.

According to the interest group Keep Antibiotics Working, many top poultry producers have announced that they no longer use such drugs in chickens produced for human consumption. Such producers include Tyson, Gold Kist, ConAgra, Perdue, Foster Farms and Claxton.

Major chicken purchasers, including McDonald’s, Wendy’s, Dairy Queen, Burger King, Domino’s, Hardee’s, Popeye’s, Subway and Bon Appetit, have instructed their suppliers to stop using this class of drugs in chickens they purchase.



On the Net:

Food and Drug Administration: http://www.fda.gov

FDA decision: http://www.fda.gov/oc/antimicrobial/baytril.pdf

AP-ES-07-28-05 1743EDT


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