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U.S. Department of Health and Human Services

Animal & Veterinary

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Environmental Warning Added to Animal Euthanasia Products

FDA Veterinarian Newsletter September/October 2003 Volume XVIII, No 5

CVM has approved two supplemental new animal drug applications (NADAs) adding an environmental warning to pentobarbital-containing euthanasia solutions. CVM initiated this label revision in response to reports of wildlife dying as a result of barbiturate intoxication. For example, an article in the Journal of the American Veterinary Medical Association (JAVMA) reported that two bald eagles that fed on the carcass of a euthanized dairy calf were unintentionally poisoned. From 1986 to 2001, the National Wildlife Health Center linked the deaths of 34 eagles to secondary pentobarbital poisoning. Many of these were associated with landfills, involving pets and domestic animals that had been euthanized and had not been covered following disposal in a landfill. To help prevent or alleviate future injury to wildlife, under this supplemental NADA, CVM is requiring that manufacturers revise labels of pentobarbital-containing euthanasia solutions to include a warning statement about the products’ hazard to wildlife.

The new, boxed warning will say:

ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.

Additional information about this supplemental NADA may be found in the July 21, 2003, Federal Register and from Dr. Thomas Moskal at 301-827-2722, e-mail Thomas.Moskal@fda.gov.

CVM maintains a program that, in part, consists of a database of adverse drug experiences. Manufacturers of veterinary drugs are required by Federal regulations to report to CVM information concerning any unexpected side effects, injury, toxicity, or sensitivity reaction to their products. CVM uses this information to improve the safety and efficacy of veterinary drugs, such as determining if changes should be made in the product labeling based upon experience with a drug by the general population.

CVM can only include incidents that are reported; and manufacturers only relay those incidents that are reported to them. CVM encourages veterinarians, pet owners, and animal producers to report veterinary adverse events to the manufacturer and to the Center so that they can be included in this database. CVM is particularly interested in receiving information about cases of wildlife intoxication from wildlife veterinarians. The telephone number for reporting adverse drug experiences to CVM is 1-800-FDA-VETS (1-888-332-8387).