Virginiamycin Risk Assessment Available for Review and Comment

November 24, 2004

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine is seeking comments on its risk assessment of the animal drug virginiamycin, which is used to promote growth and prevent or control disease in chickens, turkeys, swine, and cattle. The risk assessment estimates the risk that humans will acquire a bacterial infection that is resistant to treatment with Synercid, a human drug chemically similar to virginiamycin, potentially related to the use of virginiamycin in food-producing animals.

FDA’s Center for Veterinary Medicine (CVM) announced it would conduct the risk assessment shortly after FDA approved Synercid in 1999 for treating vancomycin-resistant E. faecium infections in humans. Both virginiamycin and Synercid belong to the class of antibiotics called streptogramins. The approval of Synercid focused increased attention on the use of virginiamycin; specifically, whether on-farm use of virginiamycin caused the development of streptogramin resistance that could result in impaired Synercid therapy for E. faecium infections in humans. The risk assessment particularly addresses streptogramin resistance that originates via foodborne pathways.

The draft risk assessment is posted on the FDA/CVM Home Page. Single copies of this draft risk assessment also are available from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855. Please enclose a self-addressed, adhesive label to assist that office in processing your request.

The draft risk assessment is being released for comment. Written comments on this draft risk assessment may be sent by January 24, 2005, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be sent to: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm . All comments should be identified with Docket Number 2004N-0479. Comments will be considered part of the public record and will be available for viewing on the Internet at http://www.fda.gov/ohrms/dockets/ and in the FDA Docket room.

Further information about the draft risk assessment may be found in the November 24, 2004, Federal Register and from Dr. Barry Hooberman, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-8557, e-mail: bhooberm@cvm.fda.gov.