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For the first time ever, the U.S. Food and Drug Administration will withdraw approval of a veterinary drug because it has caused the emergence of antibiotic resistant bacteria that threaten human health.

Bayer’s Baytril was licensed in 1996 to treat respiratory disease in chickens, and since then, strains of antibiotic-resistant campylobacter have increased. It now accounts for 21 percent of the one million campylobacter infection in people each year, according to the Centers for Disease Control and Prevention.

The FDA’s Center for Veterinary Medicine director, Stephen Sundlof, said the agency first became concerned with the drug’s safety in 2000. It moved to withdraw the approval of Baytril for the use in chickens, as well as a similar drug made by Abbott.

While Abbott complied, Bayer appealed through a five-year legal process, which finally ended with FDA Commissioner Lester Crawford withdrawing the drug’s approval. The delayed decision will finally go into effect Sept. 12 unless Bayer appeals further to an appellate court, or asks the commissioner to reconsider.

Campylobacter lives in the digestive tracts of poultry and can cause cramps, fever and bloody diarrhea when they get into humans. The infection can lead to complications such as arthritis or life-threatening blood infections. When Baytril is given to chickens, some of the bacteria are killed, but those that survive become resistant to antibiotics such as Cipro, which is the standard campylobacter treatment.

The drug-resistant strains can pass into people who eat undercooked chicken. The agency’s ruling on Baytril does not apply to other animals because they do not pass campylobacter to humans. Chickens represent a $50 billion market in the U.S.