Life Sciences Research Office (LSRO)

Evaluating Adverse Event Reporting Systems for Dietary Supplements

January 30-31, 2003

“Open Portion of Meeting”

Goals for AERS meetingJanuary 30-31, 2003

Introduce importance, controversial nature and complexity of project

Present LSRO’s objectives

Begin to formulate plan to achieve objectives

Phase I

• Review and qualitatively compare

AER in Metabolife and FDA databases

• Determine the usefulness of these

AER as signals for product safety

Phase II

• 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

Critical issues that may be considered:

• 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

FDA CFSAN database of AER associated with

dietary supplementscontaining ephedrine alkaloids

Docket Number 00N-1200

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

FDA CFSAN AER Chart Sections

1. Section 0 Incoming Report2. Section 1 Affidavits3. Section 2 Label Sample4. Section 3 Outpatient Medical Reports5. Section 4 ER/Urgent Care Records6. Section 5 Hospital Record Summaries7. Section 6 Hospital Medical Notes8. Section 7 Hospital Surgical Reports9. Section 8 Other (e.g., Autopsy Report)

FDA CFSAN AER Ephedrine Alkaloid-Containing

Dietary Supplements(1990 through 11-3-99)

Total 1176 minus duplicates = 1164

Distribution by year (n=1126)

Ranked by frequency of product reported (n=499)

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

FDA CFSAN AER Ephedrine Alkaloid-Containing Dietary Supplements

(Docket 00N-1200 obtained for LSRO review, n=273)

New Case Series (n=140) 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