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Date: August 18, 1995 
Contact:  Donald McLearn, FDA (301) 443-1130

Fluoroquinolones are the newest class of antibiotics developed for treating infections in people and animals. Another fluoroquinolone drug, enrofloxacin, was approved in 1989 to treat certain infections in pet animals.

"Sarafloxacin provides veterinarians a way of preventing disease in poultry flocks as long as it is used appropriately," said Commissioner of Food and Drugs David A. Kessler, M.D. "It is important that antibiotics for food animals be used correctly to minimize the potential for development of drug-resistant microbes."

At a public hearing in May 1994, FDA convened its Veterinary Medicine and Anti-infective Drugs Advisory Committees to consider whether use of fluoroquinolones as animal drugs would increase chances of development of drug-resistant bacteria. The committees recommended that FDA approve fluoroquinlones found to be safe and effective for animal use, but also recommended that the agency establish appropriate conditions of approval to minimize any potential for development of resistant bacteria.

FDA is cooperating with the U.S. Department of Agriculture and the Centers for Disease Control in a monitoring program to detect and prevent disease resistant microbes. Under the program, USDA periodically will test salmonella samples from animals for continued susceptibility to antimicrobial drug products. CDC will conduct similar testing on samples of human salmonella and E. coli. The manufacturer will test samples of animal E. coli to measure emergence of any resistance in the drug's target organism.

In addition, FDA's Center for Veterinary Medicine will conduct educational programs for the industry and veterinarians in the appropriate use of the product.

Sarafloxacin, which will be available only through a prescription, is manufactured by Abbott Laboratories of North Chicago, Ill., and is distributed under the trade name Saraflox.