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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Reminds Veterinarians to Correctly Use Flunixin Meglumine

FDA Veterinarian Newsletter 2007 Volume XXII, No II

The Center for Veterinary Medicine has investigated several cases of violative residue levels of flunixin meglumine in meat, and in May 2007 it issued a reminder to veterinarians about the proper use of the drug and the requirements veterinarians must meet to use the product in an extralabel manner.

CVM had received reports that flunixin meglumine was being prescribed and/or administered to cattle by an intramuscular route. However, the approved route of administration in cattle is restricted to intravenous administration. Using the drug intramuscularly is an extralabel use of the drug.

Flunixin Meglumine Injection is approved for use in cattle for the control of pyrexia associated with bovine respiratory disease and endotoxemia. It is also indicated for the control of inflammation in endotoxemia.

Intramuscular administration of flunixin meglumine can cause violative drug residues, because the drug takes longer to deplete with this route of administration than with intravenous injections.

Under certain conditions, extralabel drug use is permitted under the Animal Medicinal Drug Use Clarification Act of 1994, which modified the Federal, Food, Drug, and Cosmetic Act.

Under the law, veterinarians are permitted to use drugs in an extra-label manner, meaning in ways not approved and specified on the label. But the veterinarian must meet certain requirements, including establishing a substantially long withdrawal period, supported by scientific evidence, so that any food from the animal will not contain violative drug residues. (A withdrawal period is the time between when an animal is administered a drug and when food products—meat, milk, eggs, or other edible products—can safely be obtained from the animal.)

Approved uses of drugs have specified withdrawal times. When drugs are used in an extralabel manner, the veterinarian takes on the responsibility of making sure the withdrawal period is adequate to prevent any violative residues in food products.

A veterinarian cannot legally prescribe the use of a drug in an extralabel fashion unless the use is required to avoid animal suffering or death. CVM has discovered, though, that veterinarians have been prescribing the use of flunixin meglumine intramuscularly simply for convenience. Under the law, that reason is not sufficient to permit extralabel use.