January 6, 2012

US FDA forbids extra-label use of cephalosporins

The extra-label use of cephalosporin drugs in livestock, including dairy cattle, at unauthorised dosage levels, frequencies or routes of administration are strictly prohibited, according to an order issued by the US Food and Drug Administration (FDA).   

FDA says it is taking the action to preserve the effectiveness of cephalosporin drugs for treating diseases in humans. Prohibiting extralabel use in livestock species reduces the risk of cephalosporin resistance in certain bacterial pathogens, says the agency.

In addition, FDA prohibits using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in these species. It also prohibits use of the drug for disease prevention.

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," says Michael Taylor, FDA Deputy Commissioner for Foods.

FDA says the order does not limit the use of cephapirin, an older cephalosporin drug that FDA believes does not contribute significantly to antimicrobial resistance. Veterinarians will be allowed to prescribe cephapirin for limited extra-label use in livestock as long as they follow the dose, frequency, duration and route of administration on the label.

The new order has a comment period beginning January 6 and ending March 6, 2012.