Docket Number 00N-1200

Dietary Supplements Containing Ephedrine Alkaloids 

Adverse Event Reports Associated with the Use of Dietary Supplements Containing Ephedrine Alkaloids Compact Disc and Volume Contents New Case Series

The Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) has divided all of the 140 adverse events it received with a report date (date the adverse event form was completed) period of June 1, 1997, through March 31, 1999, (CFSAN’s New Case Series) into two compact discs (CD’s) and 27 paper copy volumes. The adverse event files for the CD’s and paper copies are divided into the following categories: Attributable Cases, Supportive Cases, Insufficient Data Cases, and Cases Not Evaluated. These files were sorted in this manner to assist the user in locating the adverse events used in CFSAN’s document titled Assessment of Public Health Risks Associated with the Use of Ephedrine Alkaloid-Containing Dietary Supplements, which is available in this docket. Provided below are the categories for the adverse events in CFSAN's New Case Series and the adverse event case numbers that fall in each category.

CATEGORY

12462, 12483, 12485, 12486, 12669, 12851, 12887, 12933, 12946, 12948, 12978, 13005, 13010, 13031, 13044, 13062, 13085, 13110, 13167, 13202, 13341, 13546

12452, 12504, 12589, 12594, 12608, 12613, 12713, 12733, 12740, 12861, 12866, 12880, 12886, 12888, 12975, 12980, 13001, 13009, 13096, 13187, 13203, 13229, 13256, 13264, 13266, 13271, 13335, 13336, 13344, 13365, 13370, 13381, 13408, 13414, 13418, 13439, 13463, 13499

11912, 11915, 11918, 11919, 12444, 12460, 12464, 12466, 12477, 12479, 12487, 12488, 12506, 12508, 12523, 12527, 12536, 12537, 12572, 12609, 12630, 12664, 12696, 12698, 12717, 12720, 12722, 12761, 12816, 12832, 12837, 12843, 12844, 12859, 12860, 12871, 12875, 12876, 12906, 12921, 12927, 12941, 12942, 12950, 12974, 12979, 12990, 13021, 13041, 13051, 13058, 13071, 13072, 13083, 13093, 13099, 13127, 13146, 13165, 13238, 13265, 13272, 13277, 13328, 13331, 13332, 13345, 13346, 13380, 13405, 13413, 13503

11913, 12671, 12842, 13032, 13125, 13351, 13545, 13168

CHART ORGANIZATION

Each adverse event report is organized by a 5-digit identifier (Adverse Event Case #). There are up to 9 sections for each adverse event chart. These sections are as follows:

Section 0 - Front - Incoming Report and Related Information

Section 1 - Affidavits

Section 2 - Label Sample

Section 3 - Outpatient - Outpatient Medical Records

Section 4 - ER Urgent - Emergency Room Department and/or Urgent Care Records

Section 5 - Summaries - Hospital Record Summaries

Section 6 - MD Notes - Hospital Medical Notes

Section 7 - Procedures - Hospital Operations/Surgical Procedures and Reports

Section 8 - Other - For example, Death certificate, Medical Examiner’s report, and autopsy report

ADDITIONAL INFORMATION ABOUT THESE 140 ADVERSE EVENT REPORTS

FDA receives adverse event reports from a variety of sources, including FDA's MedWatch program, FDA's field offices, other Federal, State, and local public health agencies, and letters, emails, and phone calls from other interested parties, such as consumers and health professionals.

The reporting of any individual adverse event alone may not be complete enough to draw a conclusion that the adverse event was caused by the use of a dietary supplement containing ephedrine alkaloids. CFSAN's Assessment (referenced earlier), however, includes a comprehensive clinical analysis of the New Case Series, as well as an extensive review of the published literature, to assess the relationship of product use to an adverse event. Also available on compact disc and paper in this docket are reviews of 139 of the 140 adverse events in the New Case Series from FDA's Center for Drug Evaluation and Research (CDER) and certain outside experts. CFSAN's assessment and the CDER and outside expert reviews can be obtained by filling out a Freedom of Information request. Submit your request in writing to the Freedom of Information Staff, Food and Drug Administration, 5600 Fishers Lane, HFI-35, Rockville, MD 20857.