Jul 29, 2005 (CIDRAP News) The Food and Drug Administration (FDA) has decided to ban the use of the antibiotic enrofloxacin (Baytril) in poultry because of the risk that it promotes drug-resistant bacteria that can be harmful to humans.
The ban will take effect Sep 12, but Bayer Corp., manufacturer of the drug, has 60 days to appeal the decision to a federal appeals court, FDA Commissioner Lester Crawford said in an announcement yesterday. The decision does not affect other approved uses of the drug.
Enrofloxacin is in the fluoroquinolone class of antibiotics. The FDA first announced its intention to ban the use of fluoroquinolones in poultry in October 2000 because of evidence that they spawn resistance in Campylobacter, a bacterium that chickens and turkeys commonly carry without becoming ill.
Abbott Laboratories, maker of sarafloxacin, another fluoroquinolone used in poultry, accepted the FDA proposal and withdrew the product. But Bayer appealed the plan, which triggered hearings in 2003 before an administrative law judge, who upheld the FDA proposal. Bayer then appealed the decision to the commissioner of the FDA.
The FDA said that when poultry are treated with enrofloxacin, some Campylobacter microbes survive and remain in carcasses that reach retail stores. If the bacteria are not killed by proper cooking, they can cause illness in humans. The illness can be severe in the very young, the elderly, and people with certain medical conditions, the agency said.
"Fluoroquinolones used in humans are ineffective if used to treat Campylobacter infections that are resistant to them," the FDA said. "This failure can significantly prolong the duration of the infections and may increase the risk of complications. The proportion of Campylobacter infections that are resistant to fluoroquinolones has increased significantly since the use of enrofloxacin in poultry was approved in the U.S."
The organization Keep Antibiotics Working, a coalition of groups concerned about drug-resistant microbes, said in a news release, "This action is the first time the FDA has ever withdrawn an agricultural antibiotic from the market because of concerns about antibiotic resistance affecting human health."
"We applaud Commissioner Crawford and the FDA for acting decisively to protect the public's health," David Wallinga, MD, MPA, director of the Antibiotic Resistance Project at the Institute for Agriculture and Trade Policy, said in the release.
An Associated Press (AP) report quoted Bayer spokesman Bob Walker as saying the company was surprised and disappointed by the decision. He said company officials would review it before deciding how to respond.
Jul 28 FDA announcement