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FDA AERS Mefloquine, Judicial Watch FOIA report~20120403
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Outcome PT Report Source Product Role Manufacturer Route Dose Duration<br />
Hospitalization - Diarrhoea Foreign Lariam PS ORAL 250.00 MG 1.0<br />
Initial or Prolonged Pyrexia Other X PER WEEK<br />
Embolism Arterial<br />
ORAL<br />
Headache Marvelon C<br />
Hemiparesis<br />
03-Apr-2012 09:37 AM Page: 14
Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Lariam PS ORAL 250.00 MG 1.0 Initial or Prolonged Pyrexia Other X PER WEEK Embolism Arterial ORAL Headache Marvelon C Hemiparesis 03-Apr-2012 09:37 AM Page: 14
<strong>FDA</strong> - Adverse Event Reporting System (<strong>AERS</strong>) Freedom Of Information (FOI) Report Date:02/04/98ISR Number: 3022672-9Report Type:Expedited (15-DaCompany Report #90763 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Lariam PS ORAL 250.0000 MG Initial or Prolonged Hyperhidrosis Health 1.0 X PER Myalgia Professional WEEK ORAL Aspartate Aminotransferase Increased Fatigue Hepatic Enzyme Increased Blood Creatine Phosphokinase Increased Skin Discolouration Myopathy Liver Function Test Abnormal Alanine Aminotransferase Increased Chest Pain Pain In Extremity Diarrhoea Hypogammaglobulinaemia Tongue Coated Cardiovascular Disorder Muscular Weakness Myocarditis Hepatic Steatosis Gamma-Glutamyltransferase Increased Headache Myoglobin Blood Increased Date:02/04/98ISR Number: 3022673-0Report Type:Expedited (15-DaCompany Report #92891 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serious Balance Disorder Foreign Lariam PS ORAL 250.0000 MG Vertigo Health 1.0 X PER Gait Disturbance Professional WEEK ORAL Dizziness Geluprane C Date:02/04/98ISR Number: 3023912-2Report Type:Expedited (15-DaCompany Report #87481 Age:54 YR Gender:Male I/FU:F Outcome Disability Other Serious PT Amnesia Fatigue Nausea Hypoaesthesia Nervous System Disorder
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