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Ephedrine Alkaloid AERs Down, Ratio Of Serious Events Up - FDA

This article was originally published in The Tan Sheet

Executive Summary

More than half of the 120 ephedrine alkaloid-related adverse event reports received by FDA since publication of the June 1997 proposed rule on the dietary supplement ingredient have involved "serious" health reactions, the agency states in separate April 14 letters to Sens. Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah). The reported events include heart attack, stroke and seizure.

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FDA will consider "public comment of the widest kind" from the "layperson to health professionals to scientists" in analyzing and changing portions of the June 1997 proposed rule on ephedrine alkaloids in dietary supplements, Commissioner Jane Henney, MD, testified at a congressional hearing Feb. 29.

Ephedrine Alkaloids Dosing, Duration Limits Withdrawn Pending Public Input

FDA will consider "public comment of the widest kind" from the "layperson to health professionals to scientists" in analyzing and changing portions of the June 1997 proposed rule on ephedrine alkaloids in dietary supplements, Commissioner Jane Henney, MD, testified at a congressional hearing Feb. 29.

Ephedrine Alkaloids Dosing, Duration Limits Withdrawn Pending Public Input

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