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

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.