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Herb-related adverse events

This article was originally published in The Tan Sheet

Executive Summary

Institute for Safe Medication Practices encourages practitioners to report herb-related adverse events, or HAEs, in its Sept. 23 "ISMP Medication Safety Alert." ISMP lists several avenues for reporting these events, including FDA's Specials Nutritionals Adverse Event Monitoring System as well as USP's Practitioners Reporting Network, which accepts reports and forwards them to FDA. ISMP notes "since only reported events can be reviewed" in FDA's system, "the absence of information does not mean a product or ingredient has not been or is not likely to be associated with an adverse event. Furthermore, a report of an HAE does not prove causation." The group adds "safety comparisons between one product and another cannot be directly obtained from HAE reports" and the "available information may not be complete enough to make these comparisons or determine the actual causes of an adverse event"
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