May 10, 2007
FDA Reminds Veterinarians on the Correct Use of Flunixin Meglumine
The Food and Drug Administration today is reminding veterinarians about the appropriate use of the drug, flunixin meglumine, for use in cattle. FDA’s Center for Veterinary Medicine (CVM) has received reports indicating that flunixin meglumine is being prescribed and/or administered by means of an intramuscular route (IM) in cattle. Flunixin meglumine’s current approved route of administration is restricted to intravenous (IV) administration in cattle.
It is important for veterinarians to prescribe and use flunixin meglumine and other drugs for food animals according to directions on the label so that adulterating residues are avoided. The intramuscular administration of flunixin meglumine has the potential to cause violative drug residues since it requires a longer withdrawal period to deplete the drug-related residue in the animal than does the approved intravenous route of administration. It is considered extra-label use to use an FDA approved product through a route of administration other than as it is approved. Extra-label use is not permitted for reasons such as convenience, yet CVM has learned that flunixin meglumine is being administered via the unapproved intramuscular route for convenience purposes
CVM has investigated a number of violative drug residues in meat that resulted from extra-label use of flunixin and wants to clarify that the Animal Medicinal Drug Use Clarification Act (AMDUCA) (http://www.fda.gov/cvm/amducatoc.htm) limits extra-label drug use to treatment when the health of an animal is threatened or suffering or death may result from failure to treat.
Only a veterinarian can prescribe a drug in an extra-label manner. In such cases, the veterinarian must establish a substantially extended withdrawal period supported by appropriate scientific information prior to the marketing of milk, meat, eggs, or other edible products to assure that violative drug residues do not occur.
The withdrawal time is the interval between the time of the last administration of a drug and the time when the animal can be safely slaughtered for food or the milk can be safely consumed. If the labeled withdrawal period is followed along with all other label directions, including route of administration, there is a high degree of assurance that treated animals or milk will be in compliance with applicable regulations, and that the edible products from such treated animals will be safe. There are established withdrawal times for approved products, such as flunixin meglumine. However, there are no approved withdrawal times for unapproved products or FDA approved products which are used in an extra-label manner.
For additional information on flunixin meglumine, please see http://www.fda.gov/cvm/FOI/200-124s071805.pdf and http://www.fda.gov/cvm/FOI/200-308s030106.pdf
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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