The U.S. Food and Drug Administration (FDA) has announced a final decision to no longer allow distribution or use of the antimicrobial drug enrofloxacin (Baytril) for the purpose of treating bacterial infections in poultry. This ruling, however, does not affect other approved uses of the drug.
This animal drug belongs to a class of drugs known as fluoroquinolones and is marketed under the name Baytril by Bayer Corporation. The drug is in the same “family” as Cipro, the widely used human antibiotic.
The FDA finally made a decision which many infectious disease experts had been calling for and directed its Center for Veterinary Medicine (CVM) to began proceedings to withdraw use of this animal drug in poultry.
The FDA now acknowledges scientific data shows that the use of enrofloxacin 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.
Enrofloxacin does not completely eliminate Campylobacter from the birds’ intestinal tracts, and those Campylobacter bacteria that survive are resistant to fluoroquinolone 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.
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. Early treatment can mitigate symptoms and may decrease the risk of complications.
Fluoroquinolones used in humans are ineffective if used to treat Campylobacter infections that are resistant to them. This failure can significantly prolong the duration of the infections and may increase the risk of complications. The proportion of Campylobacter infections that are resistant to fluoroquinolones has increased significantly since the use of enrofloxacin in poultry was approved in the U.S.
Bayer Corporation has been given 60 days to appeal the withdrawal. The final order withdrawing approval of the antimicrobial drug enrofloxacin for the purpose of treating bacterial infections in poultry will become effective on September 12, 2005.
The Final Decision can be found at www.fda.gov/oc/antimicrobial/baytril.pdf.
This ruling is seen as a step forward in the battle to stem the tide of antibiotic-resistant bacteria that are rapidly becoming a public health crisis. Critics of the FDA’s inactivity on the matter have praised this first, decisive measure to deal with the problem.