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 refers practitioners to the Animal Medicinal Drug Use Clarification Act (AMDUCA) (http://www.fda.gov/cvm/FOI/200-124s071805.pdf and http://www.fda.gov/cvm/FOI/200-308s030106.pdf.
Source:
Food and Drug Administration, CVM Update, May 10, 2007