The Food and Drug Administration is banning the use of Bayer Corp.'s Baytril in chickens, fearing the practice poses health risks for humans. The agency's veterinary medicine division had first sought its removal in 2000.
It's the first time the agency has ended the use of an animal drug because of fears that it could lead to antibiotic-resistant pathogens in humans.
The FDA's standard is that food from animals that have taken a particular drug must carry a "reasonable certainty of no harm," and the agency didn't feel that poultry treated with Baytril met that standard, an FDA spokesman said.
"Scientific data ... showed that the use of (Baytril) in poultry caused resistance to emerge in Campylobacter, a bacterium that causes foodborne illness. Chickens and turkeys normally harbor Campylobacter in their digestive tracts without causing poultry to become ill," the agency said in a statement.
Baytril (enrofloxacin) does not completely eliminate Campylobacter from the birds' intestinal tracts, and those Campylobacter bacteria that survive are resistant to some drugs.
"These resistant bacteria multiply in the digestive tracts of poultry and persist and spread through transportation and slaughter, and are found on chicken carcasses in slaughter plants and retail poultry meats," the FDA said.
Campylobacter bacteria are a significant cause of foodborne illness in the U.S. Antimicrobial treatment is recommended for people with severe illness as well as the very young, the elderly, and people with certain medical conditions. Complications of such infections can include reactive arthritis and, more rarely, blood stream infections.
Drug-resistant strains of the illness can increase the risk of complications.
Bayer Corporation has 60 days from the date of the decision to appeal the withdrawal to a U.S. Court of Appeals. Abbott Laboratories voluntarily withdrew a similar drug from voluntarily in 2000.
The U.S. is considerably more lenient than most European countries in its regulation of animal drugs. The European Union has outlawed the use of all antibiotics for animal growth by next year.
In a report last year, the Government Accountability Office, the investigative arm of Congress, called for the U.S. to move more quickly in evaluating the potential risks posed by animal antibiotics that are also important products for human health.Consumers Union online