Infectious Diseases

The Food and Drug Administration will prohibit certain uses of cephalosporins in specific food animals in an attempt to preserve the antibiotics’ effectiveness for treating human infections.

In an order issued Jan. 4, the FDA said that by April it will prohibit unapproved uses of cephalosporins in cattle, swine, chickens, and turkeys.

The order prohibits the use of cephalosporin drugs for disease prevention in food animals. Furthermore, only cephalosporin drugs that have been approved for use in cattle, swine, chickens, or turkeys are permitted for use in those species. The order also prohibits giving food animals cephalosporins at unapproved dose levels, frequencies, durations, or routes of administration. Cephalosporins that are intended for use in humans or companion animals are prohibited for use in food animals.

The decision comes more than 3 years after the agency revoked a July 2008 decision to prohibit without exception all "extralabel" uses of cephalosporins in food-producing animals. The agency revoked the original order after receiving comments from approximately 170 organizations or individuals. According to the FDA, scientific review of those comments was factored into the new order, which was greeted with support by physicians and groups concerned about the emergence of antibiotic resistance.

"Physicians must be able to rely on proven, safe, and effective medications to provide optimal care to their patients," Dr. Peter W. Carmel, president of the American Medical Association, said in a statement. "By taking this step, physicians can continue to have this class of antibiotics available to successfully fight bacterial meningitis and other serious infections."

"It’s wonderful that FDA made this move," Dr. James R. Johnson said in an interview.

Cephalosporins are "a hugely important group of antibiotics. These are workhorse, frontline, mainstream antibiotics," said Dr. Johnson, a member of the Infectious Disease Society of America’s Antimicrobial Resistance Work Group.

Cephalosporins are active against gram-positive and gram-negative bacteria, and "the biggest concern right now is resistance against gram-negatives. That’s where agricultural use has been thought to be contributing in an important way to the resistance problem – particularly salmonella and [Escherichia coli]."

Unfortunately, there are few antibiotics in development against gram-negative bacteria. "The ones that are under development are on a timeline that means they are not going to be available to us for years to come," he said.

"So we’re sort of in the position of holding on by our fingernails, dealing with these bad infections with the drugs that we currently have for the next however many years until new drugs become available," said Dr. Johnson, who is also a professor of medicine at the University of Minnesota, Minneapolis.

Dr. Johnson reported that he received grant support from several pharmaceutical companies.

01/09/12