<?xml version="1.0" encoding="UTF-8"?>
<adverse_event_case case_number="7053633">
  <adverse_event_report>
    <yyqq>09Q3</yyqq>
    <isr>6271875</isr>
    <initial_followup_code>i</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6271875-9</image>
    <event_date>2009-06-20</event_date>
    <manufacturer_date>2009-07-14</manufacturer_date>
    <fda_date>2009-07-17</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>phhy2009gb28981</manufacturer_number>
    <manufacturer_sending>novartis pharmaceuticals corp.</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>2009-07-17</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date></death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united kingdom</reporter_country>
    <outcome outcome_code="de"/>
    <reaction reaction_preferred_term="intestinal infarction"/>
    <reaction reaction_preferred_term="mesenteric artery thrombosis"/>
    <drug_datum>
      <drug_sequence>1011902723</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>clozapine</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>019758</nda_number>
      <drug_indication indication_preferred_term="psychotic disorder"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1011902724</drug_sequence>
      <role_code>c</role_code>
      <drug_name>beclometasone</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>1011902725</drug_sequence>
      <role_code>c</role_code>
      <drug_name>chlorpromazine</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>1011902726</drug_sequence>
      <role_code>c</role_code>
      <drug_name>danazol</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>1011902727</drug_sequence>
      <role_code>c</role_code>
      <drug_name>diclofenac</drug_name>
      <validated_or_verbatim>2</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_datum>
    <drug_datum>
      <drug_sequence>1011902728</drug_sequence>
      <role_code>c</role_code>
      <drug_name>fluoxetine hcl</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>1011902729</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lansoprazole</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>1011902730</drug_sequence>
      <role_code>c</role_code>
      <drug_name>orphenadrine citrate</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_datum>
    <drug_datum>
      <drug_sequence>1011902731</drug_sequence>
      <role_code>c</role_code>
      <drug_name>albuterol</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>1011902732</drug_sequence>
      <role_code>c</role_code>
      <drug_name>sulpiride</drug_name>
      <validated_or_verbatim>2</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_datum>
    <drug_datum>
      <drug_sequence>1011902733</drug_sequence>
      <role_code>c</role_code>
      <drug_name>zopiclone</drug_name>
      <validated_or_verbatim>2</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_datum>
  </adverse_event_report>
  <adverse_event_report>
    <yyqq>09Q4</yyqq>
    <isr>6505173</isr>
    <initial_followup_code>f</initial_followup_code>
    <followup_sequence></followup_sequence>
    <image>6505173-2</image>
    <event_date>2009-06-20</event_date>
    <manufacturer_date>2009-12-14</manufacturer_date>
    <fda_date>2009-12-18</fda_date>
    <report_code>exp</report_code>
    <manufacturer_number>phhy2009gb28981</manufacturer_number>
    <manufacturer_sending>novartis pharmaceutical corporation</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>2009-12-18</report_date>
    <reporter_occupation>ot</reporter_occupation>
    <death_date>2009-06-21</death_date>
    <manufacturer_notified></manufacturer_notified>
    <confidentiality_status></confidentiality_status>
    <reporter_country>united kingdom</reporter_country>
    <outcome outcome_code="de"/>
    <reaction reaction_preferred_term="abdominal compartment syndrome"/>
    <reaction reaction_preferred_term="abdominal distension"/>
    <reaction reaction_preferred_term="faecaloma"/>
    <reaction reaction_preferred_term="intestinal dilatation"/>
    <reaction reaction_preferred_term="intestinal infarction"/>
    <reaction reaction_preferred_term="intestinal ischaemia"/>
    <reaction reaction_preferred_term="intra-abdominal pressure increased"/>
    <reaction reaction_preferred_term="mesenteric artery thrombosis"/>
    <drug_datum>
      <drug_sequence>1012810933</drug_sequence>
      <role_code>ps</role_code>
      <drug_name>clozapine</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>19758</nda_number>
      <drug_indication indication_preferred_term="psychotic disorder"/>
    </drug_datum>
    <drug_datum>
      <drug_sequence>1012810934</drug_sequence>
      <role_code>c</role_code>
      <drug_name>beclometasone</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>1012810935</drug_sequence>
      <role_code>c</role_code>
      <drug_name>chlorpromazine</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>1012810936</drug_sequence>
      <role_code>c</role_code>
      <drug_name>danazol</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>1012810937</drug_sequence>
      <role_code>c</role_code>
      <drug_name>diclofenac</drug_name>
      <validated_or_verbatim>2</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_datum>
    <drug_datum>
      <drug_sequence>1012810938</drug_sequence>
      <role_code>c</role_code>
      <drug_name>fluoxetine</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>1012810939</drug_sequence>
      <role_code>c</role_code>
      <drug_name>lansoprazole</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>1012810940</drug_sequence>
      <role_code>c</role_code>
      <drug_name>orphenadrine citrate</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_datum>
    <drug_datum>
      <drug_sequence>1012810941</drug_sequence>
      <role_code>c</role_code>
      <drug_name>albuterol</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>1012810942</drug_sequence>
      <role_code>c</role_code>
      <drug_name>sulpiride</drug_name>
      <validated_or_verbatim>2</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_datum>
    <drug_datum>
      <drug_sequence>1012810943</drug_sequence>
      <role_code>c</role_code>
      <drug_name>zopiclone</drug_name>
      <validated_or_verbatim>2</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_datum>
  </adverse_event_report>
</adverse_event_case>
