Newswise — BOSTON (January 6, 2012) — The Alliance for the Prudent Use of Antibiotics (APUA) today praised the U.S. Food and Drug Administration (FDA) for acting to limit certain extra label uses of cephalosporins in major animal species – cattle, swine, chickens and turkeys –where misuse and overuse are cause for great concern. Extra label use occurs when use of a drug does not comply with the approved labeling. Such use occurs when a drug is not used for indicated: species, disease(s), dose, frequency, routes of administration and withdrawal time.
FDA has focused the spotlight on egregious abuses – in particular dairy cattle, reporting cepahlosporins (specifically, cefiofur) residue levels ten times higher than the established safety level. The concern is that such high residue levels will increase cephalosporin resistance in carcass bacteria, leading to adverse human health consequences. Other sources of increased drug exposure identified were U.S. poultry hatcheries, where ceftiofur was being injected into eggs, an unapproved method of administration, unapproved mass dosing of animals via the water supply, and the unapproved use of biobullets, whereby a solid pellet is injected into cattle. FDA noted that some cephalosporins, approved only for use in humans, are being used to treat animals.
“With this action, the FDA sets a framework for achieving the One Health Initiative, a worldwide strategy for integrating health care for humans, animals and the environment. Antibiotics and other antimicrobials should be used only to treat diseases, not to boost growth in food animals. The FDA decision moves the U.S. one step forward in public health, as eliminating massive misuse of these precious antibiotics in industrial farms will extend their power to treat human disease,” said Stuart Levy, MD, professor of molecular biology and microbiology and of medicine at Tufts University School of Medicine, director of its Center for Adaptation Genetics and Drug Resistance and president of the Alliance for the Prudent Use of Antibiotics (APUA), the leading non-profit organization dedicated to preserving the effectiveness of antibiotics and other antimicrobials.
Cephalosporins are in a class of penicillin-related antibiotics used extensively in human medicine. According to the FDA, 14% of total outpatient prescriptions for antibiotics are cephalosporins. They are used for life-threatening infections and are considered the drugs of last resort for people gravely sick with food-borne pathogens such as Salmonella and Shigella. These antibiotics are also used to treat people suffering from pneumonia, septicemia, meningitis, as well as infections of the urinary tract, bone and joint, and skin and skin structure.
Resistance to antibiotics is increasing, compromising their overall effectiveness in treating infections with antibiotics. The debate about the impact of animal use of antibiotics on human health has been raging for more than 25 years. In a scientific review published in Clinical Infectious Diseases in October 2011, Levy and co-author Bonnie Marshall, also of Tufts University School of Medicine, analyzed scientific evidence on the use of antibiotics in animal husbandry and aquaculture for non-therapeutic purposes (e.g., to promote growth) and reported overwhelming evidence that non-therapeutic use of antibiotics contributes to antibiotic resistance, even if all of the mechanisms in the genetic transmission chain are not yet fully understood. In 2002, the Facts about Antibiotics in Animals and the Impact on Resistance Report from APUA (Clinical Infectious Diseases 2002:34, Suppl 3) provided consensus from a national scientific panel and recommended that third generation or higher cephalosporins should not be used in agriculture, because of their critical role in treating human disease and the emergence of resistance to them following their overuse in animals.
“Uses of antimicrobials in animals, agriculture and humans contribute to the global pool of resistance genes in the environment. Factory farms are a major contributor to the selection and transfer of dangerous resistance elements, which promote resistance in human pathogens. The animals far outnumber humans; the volume of antibiotics used there is high; massive low dose levels are routinely applied; and infection control is inadequate. There is little sense in requiring responsible stewardship and data from the human medicine sector and not requiring the same from the food animal production sector, where sludge and downstream waterways make for massive resistance gene pools,” said Levy.
The convergence of increasing antibiotic resistance, continuing antibiotic misuse, and a dwindling antibiotic pipeline has created a global public health crisis. A 2009 APUA-sponsored study at Cook County Hospital estimated the cost of antibiotic resistance in US hospitals at greater than $20 billion annually, adding 6.4 – 12.7 hospital days per patient stay.
“We applaud the action to the FDA as a critically important first step. We encourage the FDA to proceed further with finalizing and implementing draft Guidance 209, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, which will prohibit the use of antibiotics in animals solely to boost growth and will eliminate the use of over-the-counter antibiotics in food animals, in favor of veterinary oversight.”
APUA, the Alliance for the Prudent Use of Antibiotics (www.apua.org), founded in 1981, is a global nonprofit organization dedicated to preserving the power of existing antibiotics and increasing access to needed new agents. With a chapter network spanning more than 60 countries, APUA represents the largest field presence among organizations engaged in research, education, and advocacy to improve public policy and antibiotic treatment practices worldwide.
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