Phenolphthalein safety data needed, FDA says at OTC "feedback" mtg..
This article was originally published in The Tan Sheet
Executive Summary
PHENOLPHTHALEIN HUMAN AND ANIMAL SAFETY DATA NEEDED, FDA said at a Dec. 18 OTC drug "feedback" meeting of FDA pharmacology and toxicology senior staff and OTC Products Division representatives, National Toxicology Program personnel and industry. FDA asked industry to conduct comparative studies of phenolphthalein in humans and animals after receiving results from animal studies by NTP that found evidence of carcinogenicity. FDA is trying to determine whether the animal tumorigenic data has relevance to humans.
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