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Phenolphthalein laxatives human surveillance study proposed by Novartis.

This article was originally published in The Tan Sheet

Executive Summary

PHENOLPHTHALEIN LAXATIVES HUMAN SURVEILLANCE STUDY PROPOSED by Novartis Consumer Health in June 11 comments to FDA. Pointing out that "to date, there have been no human studies that call into question the safety of phenolphthalein," Novartis, the maker of Ex-Lax, suggests conducting a case control human surveillance study to assess whether the use of phenolphthalein-containing laxatives is cause for safety concern. FDA's Carcinogenic Assessment Committee told the agency it believes existing data indicate that the ingredient presents "carcinogenic risk for humans" under conditions of exposure associated with use of phenolphthalein as an OTC laxative ("The Tan Sheet" May 26, p. 12).
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