Apr 1, 2004

IDSA urges Bayer to stop selling enrofloxacin

The Infectious Diseases Society of America (IDSA) is urging Bayer Corp. to comply with a proposed federal regulatory action and withdraw enrofloxacin (Baytril) from the market because of the concern that its use in poultry promotes drug-resistant bacteria.

The Food and Drug Administration (FDA) proposed in October 2000 to ban the use of enrofloxacin and other fluoroquinolone antibiotics in poultry because of evidence that it leads to an increase in antibiotic-resistant Campylobacter in poultry. Abbott Laboratories voluntarily withdrew its fluoroquinolone (sarafloxacin) for poultry, but Bayer opposed the proposal.

Two weeks ago, an FDA administrative law judge, Daniel J. Davidson, approved the FDA proposal to ban fluoroquinolones in poultry. Davidson agreed that the use of enrofloxacin has promoted fluoroquinolone- resistant Campylobacter in poultry. He concluded that the presence of resistant Campylobacter in poultry leads to more severe Campylobacter infections in humans.

In a statement yesterday, the IDSA said it has supported "the reasonable and measured approach" the FDA has used in evaluating the scientific data. That evaluation has shown that the use of enrofloxacin in poultry decreases the effectiveness of ciprofloxacin in treating human campylobacteriosis, the statement said.

"Now, the evidence has been weighed, a decision reached, and the decision has been upheld by the administrative law judge," said IDSA President Joseph R. Dalovisio, MD. "It is not reasonable or responsible for Bayer Corporation to continue to resist the decision, and particularly to continue to market their product during the appeals process."

Dalovisio added, "IDSA has strong concerns about Bayer's action, and we ask that they immediately cease marketing of Baytril."

In a Mar 16 statement, Bayer said it would appeal Davidson's ruling to the FDA commissioner. The company asserted that Davidson did not fully consider the human health benefits of using enrofloxacin in poultry. The drug is used to treat air sacculitis, a pneumonia-like infection. Bayer said weight variations in birds with air sacculitis lead to errors in processing that result in increased bacterial contamination.

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