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FDA AERS Mefloquine, Judicial Watch FOIA report~20120403
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Required<br />
Intervention to<br />
Prevent Permanent<br />
Impairment/Damage<br />
Panic Disorder<br />
Insomnia Related To<br />
Another Mental Condition<br />
Anxiety<br />
Personality Change<br />
Fear<br />
Insomnia<br />
Paraesthesia<br />
03-Apr-2012 09:37 AM Page: 1
Required Intervention to Prevent Permanent Impairment/Damage Panic Disorder Insomnia Related To Another Mental Condition Anxiety Personality Change Fear Insomnia Paraesthesia 03-Apr-2012 09:37 AM Page: 1
<strong>FDA</strong> - Adverse Event Reporting System (<strong>AERS</strong>) Freedom Of Information (FOI) Report Dysarthria Confusional State Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Asthenia Lariam PS Roche ORAL TABS; 250 MG Depression TAB PO ONCE Chills WEEKLY;(PT Abnormal Dreams D'CD DRUG) Date:11/10/97ISR Number: 3000073-7Report Type:Expedited (15-DaCompany Report #86849 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Lariam PS ORAL 250.000 MG Initial or Prolonged Dyspnoea Other 1.0 X PER Asthenia WEEK ORAL Bronchitis Dpt C Dizziness Yellow Fever Vaccine C Red Blood Cell Havrix C Sedimentation Rate Typhim C Increased Mercalm C Vomiting Genhevac B C Nausea Pyrexia Date:11/10/97ISR Number: 3005888-7Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Restlessness Lariam PS Depression <strong>Mefloquine</strong> SS Confusional State Emotional Disorder Memory Impairment Visual Impairment Anxiety Date:11/12/97ISR Number: 3000157-3Report Type:Expedited (15-DaCompany Report #89097 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Lariam Tablets Initial or Prolonged Lung Infiltration Professional (<strong>Mefloquine</strong> Hydrochloride) PS ORAL Date:11/12/97ISR Number: 3000321-3Report Type:Expedited (15-DaCompany Report #89246 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Uterine Contractions Foreign Lariam Tablets
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