Denatonium benzoate: review of efficacy and safety.

The efficacy and toxicity studies on denatonium benzoate are limited and may be subject to varying interpretations when viewed in the context of a potential poisoning situation. Efficacy studies to date in children have shown that in a controlled environment, addition of denatonium benzoate to an otherwise palatable liquid will decrease the volume ingested. Important considerations include the fact that the number of studies are small (two utilizing orange juice as the liquid; one using a dilute liquid detergent), and these studies involved single-test situations wherein the liquid was available to the child for a limited period of time. Inadequate data are available to analyze one orange juice study and in the other study, 7 of 30 children took more than one swallow. Depending on the "pleasantness" of the liquid (color, smell, similarity to 'drinkable' liquids in appearance) prior to addition of denatonium, it is possible that children may take more than one swallow. Toxicity data indicate a low toxicity profile. However, there are significant gaps in our knowledge, especially relating to chronic toxicity in humans, teratogenicity, and human hypersensitivity potential. The role of denatonium benzoate in preventing serious poisonings has yet to be defined. Aversive agents such as denatonium should augment but not replace proven methods of poison prevention including parental education and child-resistant closures. When selecting products for inclusion of denatonium benzoate, consideration should be given to the inherent toxicity of the product as well as the potential for long-term human exposure.(ABSTRACT TRUNCATED AT 250 WORDS)