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Life Sciences Research Office (LSRO)
Evaluating Adverse Event Reporting Systems for Dietary Supplements
January 30-31, 2003
“Open Portion of Meeting”
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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
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Phase I
• Review and qualitatively compare
AER in Metabolife and FDA databases
• Determine the usefulness of these
AER as signals for product safety
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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
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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
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FDA CFSAN database of AER associated with
dietary supplementscontaining ephedrine alkaloids
Docket Number 00N-1200
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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
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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)
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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)
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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)
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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