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Papain crackdown

This article was originally published in The Tan Sheet

Executive Summary

FDA threatens enforcement action against the makers of unapproved topical prescription drugs with papain - an ingredient from the papaya plant that also is often used in dietary supplements - if they do not halt production by Nov. 24 or shipping by Jan. 21. The agency issued the warning Sept. 23 after receiving 37 serious adverse event reports about topical drugs with papain, including low blood pressure, rapid heart rate and allergic reactions, according to an agency official. FDA also ordered a stop to the production and shipping of unapproved ophthalmic balanced salt solution drug products used to irrigate the eye during surgery





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