March 5, 1997
ANTIDOTE FOR ETHYLENE GLYCOL POISONING APPROVED
For the first time, there is an approved new animal drug for use as an antidote for ethylene glycol poisoning in dogs. Ethylene glycol is a chemical component of antifreeze and coolants and is also used as an industrial solvent for manufacturing detergents, paints, and lacquers. Ethylene glycol is sweet-tasting and dogs will drink it if the opportunity arises. It is highly toxic requiring only a few milliliters (mL) to produce toxicity.
Antizol-Vet (fomepizole) injectable was approved by FDA on November 25, 1996. The drug sponsor is Orphan Medical, Inc., Minnetonka, Minnesota. The active ingredient of this product is also known as 4-methylpyrazole. The antidote is supplied in a 1.5 mL vial and is accompanied by a 30 mL vial of sodium chloride for reconstitution. This product only may be used by or on the order of a licensed veterinarian.
In the past, veterinarians had difficulty in obtaining antidotes for animals in their care. Veterinarians often found that distributors were unwilling to supply them with antidotes that were not approved by the Food and Drug Administration. FDA's Center for Veterinary Medicine has encouraged drug sponsors to submit New Animal Drug Applications (NADAs) for antidotes so that veterinarians will have the tools they need to treat acute poisoning. Antizol-Vet is one of the first antidote products that has been found to meet the criteria for an approved NADA. Since there is now an approved antidote, CVM will no longer provide letters facilitating the sale to veterinarians of unapproved 4-methylpyrazole for ethylene glycol poisoning in dogs.
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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