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FDA AERS Mefloquine, Judicial Watch FOIA report~20120403
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Outcome<br />
Hospitalization -<br />
Initial or Prolonged<br />
PT<br />
Migraine<br />
Headache<br />
Gastroenteritis Bacterial<br />
Trance<br />
Illusion<br />
Paraesthesia<br />
03-Apr-2012 09:37 AM Page: 3
Outcome Hospitalization - Initial or Prolonged PT Migraine Headache Gastroenteritis Bacterial Trance Illusion Paraesthesia 03-Apr-2012 09:37 AM Page: 3
<strong>FDA</strong> - Adverse Event Reporting System (<strong>AERS</strong>) Freedom Of Information (FOI) Report Diarrhoea Disturbance In Attention Restlessness Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Foreign Lariam PS ORAL 250.0000 MG Health 1.0 X PER Professional WEEK ORAL Ciprobay C Date:11/17/97ISR Number: 3006058-9Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Amnesia <strong>Mefloquine</strong> PS ORAL 1 TABLET PER Fatigue WEEK Depression Prozac C Immune System Disorder Weight Decreased Decreased Appetite Date:11/17/97ISR Number: 3006086-3Report Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serious Anxiety <strong>Mefloquine</strong> PS ORAL Q WEEK PO Gastrooesophageal Reflux Disease Date:11/19/97ISR Number: 3001851-0Report Type:Expedited (15-DaCompany Report #85820 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Restlessness Foreign Lariam PS ORAL 250.000 MG Initial or Prolonged Sleep Disorder Health 1.0 X PER Trance Professional WEEK ORAL Headache Ciprobay C Psychotic Disorder Paraesthesia Migraine Illusion Gastroenteritis Bacterial Suicidal Ideation Disturbance In Attention Diarrhoea Date:11/21/97ISR Number: 3002261-2Report Type:Expedited (15-DaCompany Report #88615 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serious Dyspnoea Foreign Lariam PS ORAL 250.0000 MG
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