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Baytril:
FDA Bans Bayer Antibiotic for Poultry Use

RANDY FABI / Reuters 29jul2005

[More articles below]

 

The Food and Drug Administration on Thursday banned the use of Baytril, a poultry antibiotic made by Bayer, an unprecedented action aimed at preventing the rise of drug-resistant germs that infect people.

FDA decision:
http://www.fda.gov/oc/antimicrobial/baytril.pdf
(126 page PDF)

The FDA, which first proposed the ban five years ago, said the use of Baytril in chickens has made it difficult for doctors to treat human patients who have food poisoning. The drug was sometimes used by farmers to treat entire poultry flocks when a few birds showed signs of respiratory disease.

FDA Commissioner Lester Crawford said Baytril "has not been shown to be safe for use in poultry." The ruling, effective September 12, does not affect other approved uses of the drug.

The Union of Concerned Scientists hailed the ruling as a "big victory for public health." Bayer said it was "surprised and disappointed" and mulling whether to appeal the decision in court.

Baytril is part of a family of potent antibiotics known as fluoroquinolones, which physicians consider valuable for treating serious infections in people. The class of drugs includes Cipro, a well-known human antibiotic.

Health officials argue that the widespread use of the drug by livestock farmers was one reason that more bacteria were becoming resistant to other fluoroquinolones.

Bacteria learn to outsmart antibiotics when repeatedly exposed to the medicines. Humans may pick up drug-resistant bacteria when they eat or handle contaminated meat.

"We are surprised and disappointed with the commissioner's decision," said Bob Walker, spokesman for Bayer's U.S. animal health division. "We will soon make a determination on which course to take next."

Baytril was used in the mid-1990s to treat about 1 percent of the U.S. chicken population, Walker said.

Consumer groups and health experts welcomed the ban.

"It's a big victory for public health in that the FDA has acted to protect the efficacy of human drugs," said Margaret Mellon, food director at the Union of Concerned Scientists.

The ban is the first time the FDA has withdrawn an antibiotic drug for animals because of a concern about its impact on human use, she said.

Mellon said she hoped this would be the first of many poultry drugs to be taken off the market because of concerns about antibiotic resistance.

Bayer said sales of Baytril do not represent a major part of the company's revenue.


FDA bans Bayer antibiotic for poultry

Xinhua (China) 29jul2005

 

The US Food and Drug Administration (FDA) decided on Thursday to ban the use of Bayer's antibiotic Baytril in the poultry industry, saying use of the drug has lead to increased occurences of antibiotic-resistant food-borne infections in people.

FDA Commissioner Lester Crawford ordered the withdrawal of the approval for use of the drug in the poultry industry, and the ban will be effective as of Sept. 12.

Scientific data has shown that the use of the drug, generically known as enrofloxacin, caused resistance in a bacteria normally harbored in the digestive tracts of chickens and turkeys, called campylobacter bacteria, the FDA said.

It said enrofloxacin, part of a family of drugs known as fluoroquinolones, does not completely eliminate campylobacter, and the surviving bacteria develop a resistance which then makes fluoroquinolones less effective in treating people.

Since the beginning of the drug's use in the poultry industry in the 1990s, the proportion of antibiotic-resistant campylobacter infections in humans has risen significantly, the FDA said.

Campylobacter bacteria are a significant cause of food-borne illness in the United States. Complications of such infections can include reactive arthritis and, more rarely, blood stream infections.

source: http://english.people.com.cn/200507/29/eng20050729_199089.html 29jul2005


FDA Bans Use of Baytril in Poultry

RANDOLPH E. SCHMID / AP 29jul2005

 

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.

source: 29jul2005

 

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