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Phenolphthalein data show "carcinogenic risk for humans" in OTC laxatives, CAC concludes.

This article was originally published in The Tan Sheet

Executive Summary

PHENOLPHTHALEIN "CARCINOGENIC RISK FOR HUMANS" INDICATED BY DATA under the "conditions of exposure encountered with use of phenolphthalein as an OTC laxative," the majority of FDA's Carcinogenicity Assessment Committee members agreed during a closed session of its April 30 meeting, according to a report released the week of May 19. Fifteen of the 17 members voted "yes" to the question of whether existing data show a "relevant carcinogenic risk for humans," one voted "no," and one abstained. The report comprised the minutes of the meeting.





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