WASHINGTON (AP) â€” The Food and Drug Administration plans to ban two antibiotics widely used by poultry farmers because of a risk that humans could become infected with germs that resist treatment.
It would be the first time the government has pulled any drug to combat infections that have grown resistant to antibiotics.
Abbott Laboratories of North Chicago, Ill., maker of one of the drugs, will withdraw its antibiotic immediately, but Bayer Corp. Animal Division, of Shawnee Mission, Kan., which dominates the market, may contest the ban.
Bayer's drug, enrofloxacin, causes the development of antibiotic-resistant campylobacter bacteria, a human pathogen, and the resistance is then transferred to humans, FDA said in a statement announcing its action. ``Resistant campylobacter infections are a human health hazard,'' the agency said.
Public health organizations, including the federal Centers for Disease Control and Prevention and the World Health Organization, have advocated such a ban for years. Officials warn that resistance to antibiotics is threatening to render penicillin and other infection-fighting drugs ineffective.
But agriculture and pharmaceutical interests have successfully held them off until now.
``We feel that this was an appropriate and a necessary step,'' said Richard Wood, president of Food Animal Concerns Trust, an advocacy group that had been pushing for the ban.
The antibiotics, known as fluoroquinolones, have been available for human use since 1986 and often are prescribed to treat serious gastrointestinal illness, including from the common campylobacter bacteria. The drugs were approved for chickens, turkeys and cattle in the mid-1990s. Since, the incidence of resistance to fluoroquinolones in humans has increased dramatically.
``We want to take a look at the basis of the (FDA's) decision,'' Bayer's senior vice president, John Payne, told The Washington Post. ``We have always said if we thought our product is causing harm, we would do the right thing.''
After years of testing, the FDA concluded this year that the health of at least 5,000 Americans is affected each year by the use of these drugs in chickens.
These people eat animals that are carrying resistant campylobacter bacteria because the animals were treated with fluoroquinolones. If the bacteria make people sick and they seek treatment, fluoroquinolones will be far less effective than normal. This could be life-threatening to the elderly, to children and to people with depressed immune systems.
Resistance develops when antibiotics are overused, both by doctors treating people and by farmers treating animals. An estimated 40 percent of the nation's antibiotic use is in livestock.
The FDA selected fluoroquinolones to study because they are so commonly used and because the agency was able to collect the necessary data to directly link the drugs' use in chickens with a specific problem in people, the Post said.
The drugs, Baytril from Bayer and Sara Flox from Abbott, are used to treat respiratory problems in chickens and turkeys. Because the birds are raised in large flocks, it is impossible to treat the birds individually, so the drugs are used in drinking water for the entire flocks. About 1.5 percent of chickens are treated with the antibiotics, according to industry sources.
The FDA is reviewing the use of fluoroquinolones in cattle as part of a comprehensive examination of all agricultural antibiotic use.
On the Net:
FDA document: http://www.fda.gov/OHRMS/DOCKETS/98fr/cv0076.pdf