FDA to Prohibit Use of Cephalosporin in Food-Producing Animals
FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.
Jan 6 2012 --- The U.S. Food and Drug Administration has issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.
Antimicrobial drugs are important for treating disease in both humans and animals. This new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but revoked prior to implementation.
FDA is taking this action to preserve the effectiveness of cephalosporin drugs for treating disease in humans. Prohibiting these uses is intended to reduce the risk of cephalosporin resistance in certain bacterial pathogens.
Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections. If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects.
In its order, FDA is prohibiting what are called “extralabel” or unapproved uses of cephalosporins in cattle, swine, chickens and turkeys, the so-called major species of food-producing animals. Specifically, the prohibited uses include:
• using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
• using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals);
• using cephalosporin drugs for disease prevention.
In 2008, FDA issued and then revoked an order that prohibited extralabel uses of cephalosporins in food-producing animals with no exceptions. Today’s announcement responds to public comment and includes the following exceptions, which protect public health while considering animal health needs:
• The order does not limit the use of cephapirin, an older cephalosporin drug that is not believed by FDA to contribute significantly to antimicrobial resistance.
• Veterinarians will still be able to use or prescribe cephalosporins for limited extra-label use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.
• Veterinarians may also use or prescribe cephalosporins for extralabel uses in minor species of food-producing animals such as ducks or rabbits.
"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," said Michael R. Taylor, Deputy Commissioner for Foods.
The new order of prohibition has a comment period that will begin on Jan. 6, 2012 and close on March 6, 2012. Following the comment period, the FDA will consider the comments prior to the order of prohibition going into effect on April 5, 2012.
The lobby group the Center for Science in the Public interest (CSPI) called the FDA prohibition a small step forward on the path to preventing foodborne outbreaks from antibiotic-resistant pathogens. But the group said that the “partial step should be followed with more definitive action to protect consumers from the illnesses caused by excessive use of antibiotics in food-producing animals.”
CSPI Food Safety Director Caroline Smith DeWaal said, “FDA's action is a small step forward. The order prohibiting certain uses of cephalosporin in many food-producing animals is clearly warranted, though it may be too little, and it is definitely too late. CSPI has identified at least five foodborne outbreaks since 2001 linked to cephalosporin-resistant Salmonella, which resulted in at least 200 illnesses and one death.”
“Extralabel use of cephalosporin is only a part of the problem. FDA should act soon to restrict or eliminate all unnecessary uses of antibiotics critically important to human medicine, so they can be preserved for future generations.”
According to Dr. Margaret Chan, Director-General of the World Health Organization, without urgent corrective action, "the world is on the brink of losing these miracle cures."
DeWaal noted that recently, FDA rejected a petition by CSPI and other organizations to ban subtherapeutic uses of antibiotics in animals. The use of antibiotics in livestock increases the prevalence of antibiotic-resistant pathogens, which leads to infections in humans that are difficult or impossible to treat.
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