Benzocaine studies
This article was originally published in The Tan Sheet
Executive Summary
A retrospective analysis of the dose-response relationship between 10% and 20% strengths of benzocaine "does not adequately support the dose response" of drug, FDA says in Oct. 29 letter responding to CHPA data submission (1"The Tan Sheet" July 8, 2002, p. 15). Agency reiterates call for one efficacy study to evaluate both 10%, 20% benzocaine compared with placebo for toothache. In addition, FDA advises study labeling must include language that directs consumer to seek treatment if relief is not obtained after several doses. Finally, agency requests updated assessment of methemoglobinemia cases associated with benzocaine use...
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