Fda Center For Veterinary Medicine
FDA Withdraws Approval of Two Poultry Drugs - new animal drug applications for use of sarafloxacin antimicrobial drugs - Brief Article Effective April 30, the FDA's Center for Veterinary Medicine (CVM) withdrew the approvals of two new animal drug applications (NADAs). Sponsored by Abbott Laboratories, the NADAs provide for use of sarafloxacin antimicrobial drugs to help keep poultry from dying of Escherichia coli (E. coli) infection. One is NADA 141017 for SaraFlox (sarafloxacin hydrochloride) WSP, a water-soluble powder used in the drinking water of broiler chickens and growing turkeys. The other is NADA 141018 for SaraFlox (sarafloxacin hydrochloride) Injection, an injectable solution used in 18-day fertile broiler eggs and day-old broiler chickens.
Last year, CVM informed Abbott Laboratories that, on the basis of new data and information, there is a potential for humans to develop antibiotic-resistant infections from consuming poultry that has been treated with fluoroquinolones such as sarafloxacin. Specifically, CVM has determined that:
* The use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistant Campylobacter (a bacterium that can cause disease in humans);
* This fluoroquinolone-resistant Campylobacter is transferred to humans and is a significant cause of the development of fluoroquinolone-resistant Campylobacter infections in humans; and
* Fluoroquinolone-resistant Campylobacter infections are a hazard to human health. (See "Antibiotic Resistance From Down on the Chicken Farm," JanuaryFebruary 2001 FDA Consumer.)
Fluoroquinolones also are approved for use in humans, and they are considered to be one of the most valuable antimicrobial drug classes available to treat human infections because of their spectrum of activity, safety, and ease of administration. This class of drugs is effective against a wide range of human diseases and is used to both treat and prevent bacterial infections in the community and in hospitals.
Physicians use fluoroquinolones routinely to treat foodborne diseases, which have a major public health consequence in the United States. After CVM informed Abbott Laboratories of this human food safety question, Abbott requested voluntary withdrawal of approval of NADAs 141-017 and 141-018.
Further information about CVM's concern about antimicrobial resistance related to drug use in food-producing animals may be found at www.fda.gov/cvm/antimicrobial/antimicrobial.html.
Serious Product Problem? Report It
Health professionals can report serious adverse reactions or other product problems to the FDA's MedWatch program by:
* Mail: Use the postage-paid MedWatch form, available from the FDA Web site or by calling the toll-free number below.
* Phone: 1-800-FDA-1088 (1-800-332-1088)
* Fax: 1-800-FDA-0178 (1-800-332-0178)
* Internet: www.fda.gov/medwatch/
Call the 800 number or visit the Web site for further assistance.
The FDA encourages consumers to report through their doctors, but if they prefer, they may submit the MedWatch form themselves.
COPYRIGHT 2001 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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