<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="6663386">
  <adverse_event_report>
    <yyqq>08Q2</yyqq>
    <isr>5767035</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5767035-8</image>
    <event_date>2008-06-08</event_date>
    <manufacturer_date>2008-06-10</manufacturer_date>
    <fda_date>2008-06-12</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-wye-h04425708</manufacturer_number>
    <manufacturer_sending>wyeth pharmaceuticals inc.</manufacturer_sending>
    <age>85.0</age>
    <age_units>YR</age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2008-06-12</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date>2008-06-08</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="DE"/>
    <reaction reaction_preferred_term="ASPHYXIA"/>
    <reaction reaction_preferred_term="COMPLETED SUICIDE"/>
    <drug_datum>
      <drug_sequence>1010020503</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>pristiq</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>021992</nda_number>
      <drug_indication indication_preferred_term="MAJOR DEPRESSION"/>
      <therapy>
        <start_date>2008-05-01</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>08Q3</yyqq>
    <isr>5805472</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>5805472-3</image>
    <event_date>2008-06-08</event_date>
    <manufacturer_date>2008-07-01</manufacturer_date>
    <fda_date>2008-07-10</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-wye-h04425708</manufacturer_number>
    <manufacturer_sending>wyeth pharmaceuticals inc.</manufacturer_sending>
    <age>85.0</age>
    <age_units>YR</age_units>
    <gender>m</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight>81.72</weight>
    <weight_units>KG</weight_units>
    <report_date>2008-07-10</report_date>
    <reporter_occupation>md</reporter_occupation>
    <death_date>2008-06-08</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="de"/>
    <reaction reaction_preferred_term="asphyxia"/>
    <reaction reaction_preferred_term="completed suicide"/>
    <drug_datum>
      <drug_sequence>1010152311</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>pristiq</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number>021992</nda_number>
      <drug_indication indication_preferred_term="major depression"/>
      <therapy>
        <start_date>2008-05-30</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1010152312</drug_sequence>
      <role_code>c</role_code>
      <drug_name>buspar</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="anxiety"/>
      <therapy>
        <start_date>2008-05-25</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1010152313</drug_sequence>
      <role_code>c</role_code>
      <drug_name>sinequan</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>oral</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="depression"/>
      <therapy>
        <start_date>2008-05-17</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1010152314</drug_sequence>
      <role_code>c</role_code>
      <drug_name>l-methylfolate</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number></lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <therapy>
        <start_date>2008-06-02</start_date>
        <end_date></end_date>
        <duration></duration>
        <duration_units></duration_units>
      </therapy>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
