September 15, 2003

 

 Warning added to euthanasia products - September 15, 2003

Posted on September 1, 2003
 

The Food and Drug Administration's Center for Veterinary Medicine is adding an environmental warning to labels of pentobarbital-containing euthanasia solutions. The FDA hopes the two supplemental new animal drug applications that require manufacturers to revise these labels will help prevent or alleviate future injury to wildlife.

The FDA says it initiated the revision because of reports of wildlife dying from barbiturate intoxication, including a news article in the Jan. 15, 2002, JAVMA. For example, from 1986-2001, the National Wildlife Health Center linked the deaths of 34 eagles to secondary pentobarbital poisoning. Poisonings occur for various reasons, including people leaving carcasses in fields, burying dead animals in shallow graves, or leaving carcasses uncovered in landfills.

The new warning will state the following:

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.

The CVM maintains a pharmacovigilance program that, in part, consists of a database of adverse drug experiences. Federal regulations require veterinary drug manufacturers to report information to the CVM concerning any unexpected side effects, injury, toxicity, or sensitivity reaction. The CVM uses this information in determining whether manufacturers need to revise their products' labels. The CVM encourages consumers and wildlife veterinarians in particular to report wildlife poisonings and other adverse events by calling the CVM at (888) FDA-VETS (888-332-8387).