<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7032295">
  <adverse_event_report>
    <yyqq>09Q2</yyqq>
    <isr>6243466</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6243466-7</image>
    <event_date>2008-01-01</event_date>
    <manufacturer_date>2009-06-18</manufacturer_date>
    <fda_date>2009-06-24</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-aventis-200915377us</manufacturer_number>
    <manufacturer_sending>sanofi-aventis</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-06-24</report_date>
    <reporter_occupation>cn</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="blood glucose increased"/>
    <reaction reaction_preferred_term="cataract"/>
    <drug_datum>
      <drug_sequence>1011785839</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>lantus</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>subcutaneous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>u233</lot_number>
      <expiration_date></expiration_date>
      <nda_number>21081</nda_number>
      <drug_indication indication_preferred_term="type 2 diabetes mellitus"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011785840</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>opticlik grey</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>unk</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="type 2 diabetes mellitus"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011785841</drug_sequence>
      <role_code>c</role_code>
      <drug_name>hyzaar</drug_name>
      <validated_or_verbatim>1</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011785842</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lipitor</drug_name>
      <validated_or_verbatim>1</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011785843</drug_sequence>
      <role_code>c</role_code>
      <drug_name>glyburide</drug_name>
      <validated_or_verbatim>1</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011785844</drug_sequence>
      <role_code>c</role_code>
      <drug_name>vitamins</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011785845</drug_sequence>
      <role_code>c</role_code>
      <drug_name>gabapentin</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>
    </drug_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6377702</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6377702-3</image>
    <event_date>2008-01-01</event_date>
    <manufacturer_date>2009-08-19</manufacturer_date>
    <fda_date>2009-09-25</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>us-aventis-200915377us</manufacturer_number>
    <manufacturer_sending>sanofi-aventis</manufacturer_sending>
    <age></age>
    <age_units></age_units>
    <gender>f</gender>
    <is_electronic_submission>true</is_electronic_submission>
    <weight></weight>
    <weight_units></weight_units>
    <report_date>2009-09-25</report_date>
    <reporter_occupation>cn</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united states</reporter_country>
    <outcome outcome_code="ot"/>
    <reaction reaction_preferred_term="blood glucose increased"/>
    <reaction reaction_preferred_term="cataract"/>
    <reaction reaction_preferred_term="glycosylated haemoglobin increased"/>
    <reaction reaction_preferred_term="product quality issue"/>
    <drug_datum>
      <drug_sequence>1012335557</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>lantus</drug_name>
      <validated_or_verbatim>1</validated_or_verbatim>
      <administration_route>subcutaneous</administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>u233</lot_number>
      <expiration_date></expiration_date>
      <nda_number>21081</nda_number>
      <drug_indication indication_preferred_term="type 2 diabetes mellitus"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335558</drug_sequence>
      <role_code>ss</role_code>
      <drug_name>opticlik grey</drug_name>
      <validated_or_verbatim>2</validated_or_verbatim>
      <administration_route></administration_route>
      <dechallenge_code></dechallenge_code>
      <rechallenge_code></rechallenge_code>
      <lot_number>unk</lot_number>
      <expiration_date></expiration_date>
      <nda_number></nda_number>
      <drug_indication indication_preferred_term="type 2 diabetes mellitus"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335559</drug_sequence>
      <role_code>c</role_code>
      <drug_name>hyzaar</drug_name>
      <validated_or_verbatim>1</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335560</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lipitor</drug_name>
      <validated_or_verbatim>1</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335561</drug_sequence>
      <role_code>c</role_code>
      <drug_name>glyburide</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335562</drug_sequence>
      <role_code>c</role_code>
      <drug_name>vitamins</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>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012335563</drug_sequence>
      <role_code>c</role_code>
      <drug_name>gabapentin</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>
    </drug_datum>
  </adverse_event_report>
</adverse_event_case>
