Post L O, Keller W C
Division of Epidemiology and Surveillance, Food and Drug Administration, Rockville, MD 20855, USA.
Vet Hum Toxicol. 1999 Aug;41(4):258-61.
Lack of commercially available antidotes for animals is an issue of significant concern to the American Board of Veterinary Toxicology. A few antidotes are available for food animals through extra-label use, regulatory discretion and compounding. However, regulatory restrictions arising from human food, safety concerns have limited the availability of food animal antidotes. Use of some antidotes in food animals requires establishment of an investigational new animal drug application. Antidotes are generally more available for non-food animals from several sources: approved animal drugs, extra-label use of approved animal and human drugs, regulatory discretion and compounding. Present alternatives are discussed as well as the need for legislation to increase antidote availability. Human food safety will always be an issue for food animal antidotes. Future availability of non-food animal and food animal antidotes will depend on several mechanisms and may include the establishment of veterinary antidote depots. Stakeholders are encouraged to participate in identifying and implementing these mechanisms.
缺乏适用于动物的商用解毒剂是美国兽医毒理学委员会极为关注的一个问题。通过超说明书用药、监管部门的自由裁量权和配制,有几种解毒剂可用于食用动物。然而,出于对人类食品安全的担忧而产生的监管限制,限制了食用动物解毒剂的可得性。在食用动物中使用某些解毒剂需要提交一份新动物药物研究申请。从多个来源来看,非食用动物通常更容易获得解毒剂:已批准的动物药物、已批准的动物和人类药物的超说明书用药、监管部门的自由裁量权和配制。文中讨论了目前的替代方法以及增加解毒剂可得性的立法需求。对于食用动物解毒剂而言,人类食品安全始终是一个问题。未来非食用动物和食用动物解毒剂的可得性将取决于多种机制,可能包括建立兽医解毒剂储备库。鼓励利益相关者参与确定和实施这些机制。