Life Sciences Research Office (LSRO)

1. Life Sciences Research Office (LSRO) Evaluating Adverse Event Reporting Systems for Dietary Supplements January 30-31, 2003 “Open Portion of Meeting”

2. Introduce importance, controversial nature and complexity of project Present LSRO’s objectives Begin to formulate plan to achieve objectives Goals for AERS meetingJanuary 30-31, 2003

3. Review and qualitatively compare AER in Metabolife and FDA databases Determine the usefulness of these AER as signals for product safety Phase I

4. Review systems for reporting adverse events for dietary supplements In a detailed LSRO report, recommend features of an AERS to the dietary supplement industry --How to collect, document, and respond to AER --How to evaluate aggregate data to obtain useful and reliable signals of potential problems Phase II

5. AER systems for OTC drugs, foods and dietary supplements Models for evaluation of data Type of data necessary Additional data Responsibilities of consumers and healthcare providers Signals generated by evaluations of AER Types of responses associated with these signals Critical issues that may be considered:

6. FDA CFSAN database of AER associated withdietary supplementscontaining ephedrine alkaloids Docket Number 00N-1200

7. FDA CFSAN AER associated with dietary supplements • Each AER is assigned a 5 digit case number • Each case has a chart • The chart has up to 9 sections

8. Section 0 Incoming Report Section 1 Affidavits Section 2 Label Sample Section 3 Outpatient Medical Reports Section 4 ER/Urgent Care Records Section 5 Hospital Record Summaries Section 6 Hospital Medical Notes 8. Section 7 Hospital Surgical Reports 9. Section 8 Other (e.g., Autopsy Report) FDA CFSAN AER Chart Sections

9. Total 1176 minus duplicates = 1164 Distribution by year (n=1126) Ranked by frequency of product reported (n=499) FDA CFSAN AEREphedrine Alkaloid-ContainingDietary Supplements(1990 through 11-3-99)

10. FDA CFSAN AER Ephedrine Alkaloid-Containing Dietary Supplements (Docket 00N-1200 obtained for LSRO review, n=273) Pre-Case Series n=14 Prior to 6-1-97 (and not in docket 95N-0304) New Case Series n=140 6-1-97 to 3-31-99 Post Case Series n=119 4-1-99 to 12-31-99

11. Attributable n=22 [e.g., used as directed, temporal, de/rechallenge, signs and symptoms consistent with known effects of ephedrine] Supportive n=38 [e.g., incomplete medical record, other confounding factors] Insufficient Data n=72 Not Evaluated n=8 New Case Series (n=140)