Ephedra safety study

Acute phase results from industry-sponsored research will be available Nov. 1 "at the latest," the Ephedra Research Foundation tells FDA June 12; the study is under way at Beth Israel-Deaconess Medical Center (Boston) and St. Luke's-Roosevelt Hospital (New York City). Results initially were expected to be ready May 1. The foundation requests FDA "delay the issuance of any final rule or guidance document" on ephedra as a dietary supplement ingredient, until the agency has reviewed results of the acute phase. As of May 31, 69 of 150 subjects had completed the acute phase in which mildly to severely overweight subjects are administered medication containing ephedra alkaloids and caffeine and are monitored for blood pressure increase, heart rate and prevalence of arrhythmia ("The Tan Sheet" Dec. 8, 1997, p. 20)...