July 15, 2004


 Flunixin, sulfadimethoxine used illegally

Posted July 1, 2004

The Food and Drug Administration continues to crack down on food animal veterinarians for illegal extralabel drug use, including that of flunixin and sulfadimethoxine. Several veterinarians have received warning letters regarding their illegal practices.

In two instances, veterinarians prescribed and dispensed sulfadimethoxine 12.5 percent oral solution for extralabel use by administering it intravenously in lactating dairy cattle. The extralabel use of sulfonamide drugs in lactating dairy cattle is prohibited. While approved label uses of sulfadimethoxine drugs are not prohibited by regulation, the intravenous route of administration is not an approved use.

In another instance, a veterinarian prescribed and dispensed flunixin for extralabel use, which caused an illegal residue in a cow sold for human consumption. Flunixin is not approved for use in lactating or dry dairy cows. The extralabel drug use regulations prohibit any extralabel use that results in a residue above an established tolerance.

Prior to prescribing or dispensing an approved animal drug for an extralabel use in food animals, the veterinarian must make a careful diagnosis and evaluation of the condition for which the drug is to be used; establish a substantially extended withdrawal period prior to marketing an edible product; institute procedures to ensure that the identity of the treated animal or animals is carefully maintained; and take appropriate measures to ensure that assigned time frames for withdrawal are met. This includes specifying a withdrawal/discard time on a drug label for any food that might be derived from a treated animal.

To obtain a copy of the "FDA and the Veterinarian" booklet and "Animal Medicinal Drug Use Clarification Act" brochure, free of charge, call the AVMA at (800) 248-2862, Ext. 6636.