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Bisacodyl laxative six-month carcinogenicity study in mice planned by NDMA.

This article was originally published in The Tan Sheet

Executive Summary

BISACODYL SIX-MONTH CARCINOGENICITY STUDY IN MICE to be conducted by the Nonprescription Drug Manufacturers Association Bisacodyl Task Group, NDMA says in a Sept. 29 letter to FDA. Intended to verify the safety of the OTC stimulant laxative ingredient, the study is being organized in response to FDA's request for additional data to substantiate bisacodyl's Category I (safe and effective) status. FDA's Carcinogenicity Assessment Committee recommended further study of bisacodyl at its April 30 meeting on phenolphthalein ("The Tan Sheet" May 5, p. 6). Although the meeting was held to consider the National Toxicology Program's carcinogenicity data for phenolphthalein, CAC suggested genotoxicity testing for several other stimulant laxative ingredients, including bisacodyl, aloe, senna and cascara sagrada.

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