Lantus combined with Optipen (Insulin Pump)

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Foreign Body Trauma Hospitalization 79 Male 1/6/2006 Consumer Egypt
Primary
Secondary
Visual Field Defect Other Serious 9/19/2005 77 Male 1/10/2006
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 8/31/2005 77 Male 1/10/2006
Primary
Secondary
Concomitant
Ketoacidosis Hospitalization Female 1/17/2006 Physician Germany
Primary
Secondary
Pharmaceutical Product Complaint Other Serious 10/1/2005 45 Male 1/19/2006 Other Health Professional Switzerland
Primary
Secondary
Pharmaceutical Product Complaint Other Serious Female 1/19/2006 Physician Switzerland
Primary
Secondary
Hyperglycaemia Other Serious 11/25/2005 12 Male 1/19/2006 Other Health Professional Switzerland
Primary
Secondary
Suicide Attempt Hospitalization 7/26/2005 21 Female 1/27/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 1/31/2006 Physician Switzerland
Primary
Secondary
Lung Neoplasm Malignant Other Serious 11/1/2005 68 Male 133 lb 2/16/2006 Physician Japan
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 12/24/2005 73 Male 194 lb 2/24/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Small For Dates Baby Other Serious 3/4/2005 28 Female 3/6/2006 Physician Japan
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 11/1/2005 68 Male 133 lb 3/9/2006 Physician Japan
Primary
Secondary
Concomitant
Premature Baby Other Serious 3/4/2005 28 Female 3/13/2006 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 7/29/2005 48 Male 161 lb 3/23/2006
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 3/23/2006 Other Health Professional Switzerland
Primary
Secondary
Pharmaceutical Product Complaint Other Serious 11/25/2005 12 Male 3/24/2006 Other Health Professional Switzerland
Primary
Secondary
Wrong Drug Administered Life Threatening 1/1/2006 87 Female 3/27/2006 Belgium
Primary
Secondary
Concomitant
Wrong Drug Administered Other Serious 1/1/2006 87 Female 3/30/2006 Belgium
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Hospitalization 10/3/2005 8 Male 5/9/2006 Other Health Professional Finland
Primary
Secondary
Concomitant
Foreign Body Trauma Other Serious 4/28/2006 27 Male 152 lb 5/17/2006
Primary
Secondary
Wound Secretion Other Serious 5/26/2005 29 Female 132 lb 6/13/2006 Other Health Professional Japan
Primary
Secondary
Hyperglycaemia Hospitalization 6/4/2006 38 Male 6/26/2006 Consumer South Africa
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 9/27/2004 32 Male 126 lb 7/7/2006 Physician Japan
Primary
Secondary
Concomitant
Diabetic Retinopathy Other Serious 6/1/2005 43 Female 134 lb 7/7/2006 Physician Japan
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 1/24/2005 30 Male 123 lb 7/7/2006 Physician Japan
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 4/30/2004 55 Female 7/7/2006 Physician Japan
Primary
Secondary
Concomitant
Vitreous Haemorrhage Hospitalization 5/23/2005 30 Female 123 lb 7/10/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/19/2006 10 Male 73 lb 7/13/2006 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 6/19/2006 10 Male 73 lb 7/21/2006 Other Health Professional United States
Primary
Secondary
Macular Oedema Other Serious 4/30/2004 55 Female 7/26/2006 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization Male 8/7/2006 Consumer United Kingdom
Primary
Secondary
Pharmaceutical Product Complaint Hospitalization Male 8/7/2006 Consumer United Kingdom
Primary
Secondary
Hyperglycaemia Hospitalization 6/1/2006 13 Male 66 lb 8/10/2006 Physician Brazil
Primary
Secondary
Concomitant
Diabetic Retinopathy Other Serious 6/1/2004 35 Female 140 lb 8/10/2006 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Death 71 Male 8/15/2006 Consumer
Primary
Secondary
Concomitant
Diabetic Retinopathy Other Serious 6/1/2004 35 Female 140 lb 8/21/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/16/2006 65 Female 196 lb 8/23/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/16/2006 65 Female 196 lb 8/28/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/16/2006 65 Female 196 lb 9/1/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Upper Limb Fracture Life Threatening 7/29/2005 48 Male 161 lb 9/8/2006
Primary
Secondary
Concomitant
Diabetic Retinopathy Other Serious 6/1/2004 35 Female 140 lb 9/25/2006 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 6/1/2006 13 Male 66 lb 11/2/2006 Physician Brazil
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 2/1/2006 13 Male 66 lb 11/28/2006 Physician Brazil
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 11/1/2006 37 Male 11/29/2006 Consumer Brazil
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Hospitalization 6/4/2006 38 Male 12/11/2006 Other Health Professional South Africa
Primary
Secondary
Concomitant
Vision Blurred Other Serious 11/1/2006 37 Male 143 lb 12/11/2006 Consumer Brazil
Primary
Secondary
Concomitant
Vomiting Hospitalization 16 Female 143 lb 1/8/2007 Consumer Brazil
Primary
Secondary
Concomitant
Vomiting Hospitalization 16 Female 143 lb 1/16/2007 Consumer Brazil
Primary
Secondary
Concomitant
Melaena Life Threatening Male 267 lb 1/25/2007 Physician Serbia And Montenegro
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/1/2006 84 Female 154 lb 2/7/2007 Consumer Brazil
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/1/2006 84 Female 154 lb 2/15/2007 Physician Brazil
Primary
Secondary
Concomitant
Limb Injury Hospitalization Male 2/27/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/1/2006 84 Female 154 lb 3/2/2007 Physician Brazil
Primary
Secondary
Concomitant
Ketoacidosis Hospitalization Female 126 lb 3/5/2007 Consumer Brazil
Primary
Secondary
Concomitant
Limb Injury Hospitalization Male 3/5/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Melaena Life Threatening 1/14/2007 53 Male 267 lb 3/8/2007 Physician Serbia And Montenegro
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 42 Female 128 lb 3/13/2007 Physician Brazil
Primary
Secondary
Concomitant
Gout Hospitalization Male 3/14/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/3/2007 Male 3/27/2007 Pharmacist Sweden
Primary
Secondary
Myocardial Infarction Hospitalization Female 3/29/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/1/2006 84 Female 154 lb 4/5/2007 Physician Brazil
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization Female 4/5/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Vomiting Disability 2/15/2007 13 Female 104 lb 4/9/2007 Physician Brazil
Primary
Secondary
Vomiting Hospitalization 3/3/2007 Male 4/17/2007 Pharmacist Sweden
Primary
Secondary
Vomiting Hospitalization 3/3/2007 Male 4/19/2007 Pharmacist Sweden
Primary
Secondary
Vomiting Disability 2/15/2007 13 Female 104 lb 4/24/2007 Physician Brazil
Primary
Secondary
Visual Disturbance Disability 11/1/2006 Female 88 lb 4/25/2007 Consumer Brazil
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/3/2007 Male 4/27/2007 Pharmacist Sweden
Primary
Secondary
Vomiting Other Serious 3/3/2007 Male 5/2/2007 Pharmacist Sweden
Primary
Secondary
Visual Disturbance Disability 11/1/2006 Female 88 lb 5/2/2007 Consumer Brazil
Primary
Secondary
Concomitant
Hepatic Function Abnormal Disability 5/20/2004 55 Female 121 lb 6/1/2007 Physician Japan
Primary
Secondary
Vision Blurred Hospitalization 1/1/2006 Male 174 lb 6/8/2007 Consumer Brazil
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 3/1/2007 35 Female 112 lb 6/8/2007 Consumer Brazil
Primary
Secondary
Concomitant
Weight Increased Hospitalization 16 Female 143 lb 6/15/2007 Consumer Brazil
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 3/1/2007 35 Female 112 lb 6/15/2007 Consumer Brazil
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 6/1/2007 53 Male 209 lb 6/20/2007 Other Health Professional Brazil
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 1/1/2006 Male 174 lb 6/29/2007 Consumer Brazil
Primary
Secondary
Concomitant
Proteinuria Disability 1/1/2007 58 Male 249 lb 6/29/2007 Consumer Brazil
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 6/1/2007 53 Male 209 lb 7/2/2007 Other Health Professional Brazil
Primary
Secondary
Concomitant
Pain In Extremity Life Threatening 11/1/2006 52 Female 7/6/2007 Consumer Turkey
Primary
Secondary
Pyrexia Other Serious 6/8/2007 65 Male 7/10/2007 Consumer China
Primary
Secondary
Myocardial Infarction Other Serious 71 Male 7/11/2007 Consumer
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 5/1/2007 51 Male 198 lb 7/13/2007 Consumer Brazil
Primary
Secondary
Concomitant
Off Label Use Other Serious 6/1/2007 56 Female 95 lb 7/13/2007 Physician Brazil
Primary
Secondary
Concomitant
Medication Error Hospitalization 1/1/2005 Female 143 lb 7/24/2007 Consumer Brazil
Primary
Secondary
Syncope Hospitalization 1/1/2004 Male 139 lb 7/25/2007 Consumer Brazil
Primary
Secondary
Treatment Noncompliance Other Serious 6/1/2007 56 Female 95 lb 7/26/2007 Physician Brazil
Primary
Secondary
Concomitant
Syncope Hospitalization 1/1/2004 Male 139 lb 7/30/2007 Consumer Brazil
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 1/1/2007 95 Female 8/8/2007 Denmark
Primary
Secondary
Hepatic Function Abnormal Hospitalization 2/12/2004 55 Male 132 lb 8/8/2007 Japan
Primary
Secondary
Concomitant
Somnolence Disability Female 134 lb 8/13/2007 Consumer Brazil
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 1/1/2007 95 Female 8/13/2007 Denmark
Primary
Secondary
Tremor Other Serious 73 Male 168 lb 8/15/2007 Consumer Brazil
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 1/1/2007 95 Female 8/16/2007 Denmark
Primary
Secondary
Hepatic Function Abnormal Hospitalization 2/12/2004 55 Male 132 lb 8/16/2007 Japan
Primary
Secondary
Concomitant
Ketoacidosis Hospitalization 7/1/2007 73 Male 143 lb 8/17/2007 Consumer Brazil
Primary
Secondary
Concomitant
Somnolence Disability Female 134 lb 8/17/2007 Physician Brazil
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 5/1/2007 51 Male 198 lb 8/17/2007 Physician Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 6/29/2007 Female 8/20/2007 Consumer Argentina
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 6/1/2007 56 Female 95 lb 8/20/2007 Physician Brazil
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 1/1/2007 95 Female 8/20/2007 Denmark
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/8/2007 Female 8/22/2007 Consumer Argentina
Primary
Secondary
Concomitant
Weight Decreased Life Threatening 8/25/2007 51 Female 185 lb 8/31/2007 Consumer Turkey
Primary
Secondary
Concomitant
Weight Increased Hospitalization 12/1/2006 25 Female 132 lb 9/5/2007 Consumer Brazil
Primary
Secondary
Concomitant
Respiratory Arrest Other Serious 9/18/2006 1 Male 22 lb 9/5/2007 Consumer Brazil
Primary
Secondary
Vomiting Hospitalization 7/1/2007 73 Male 143 lb 9/5/2007 Consumer Brazil
Primary
Secondary
Concomitant
Somnolence Disability Female 134 lb 9/6/2007 Physician Brazil
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Other Serious 8/27/2007 6 Male 44 lb 9/6/2007 Physician Brazil
Primary
Secondary
Concomitant
Respiratory Arrest Other Serious 9/18/2006 1 Male 22 lb 9/12/2007 Consumer Brazil
Primary
Secondary
Concomitant
Speech Disorder Hospitalization Male 121 lb 9/14/2007 Consumer Brazil
Primary
Secondary
Weight Increased Hospitalization 12/1/2006 25 Female 132 lb 9/17/2007 Physician Brazil
Primary
Secondary
Concomitant
Sense Of Oppression Other Serious 8/1/2007 70 Female 170 lb 9/19/2007 Consumer Turkey
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 37 Male 176 lb 9/24/2007 Consumer Brazil
Primary
Secondary
Concomitant
Skin Disorder Hospitalization Male 121 lb 9/25/2007 Physician Brazil
Primary
Secondary
Hypoglycaemic Seizure Other Serious 8/27/2007 6 Male 44 lb 9/26/2007 Physician Brazil
Primary
Secondary
Concomitant
Sense Of Oppression Other Serious 8/1/2007 70 Female 170 lb 9/26/2007 Consumer Turkey
Primary
Secondary
Concomitant
Medication Error Hospitalization 9/27/2007 72 Male 10/5/2007 Consumer Brazil
Primary
Secondary
Concomitant
Tremor Other Serious 3 Female 36 lb 10/10/2007 Physician Brazil
Primary
Secondary
Sense Of Oppression Other Serious 8/1/2007 70 Female 170 lb 10/19/2007 Physician Turkey
Primary
Secondary
Concomitant
Off Label Use Hospitalization 15 Female 132 lb 10/24/2007 Consumer Brazil
Primary
Secondary
Concomitant
Sense Of Oppression Other Serious 8/1/2007 70 Female 170 lb 10/24/2007 Physician Turkey
Primary
Secondary
Concomitant
Off Label Use 15 Female 132 lb 10/29/2007 Physician Brazil
Primary
Secondary
Concomitant
Syncope Hospitalization 8/1/2007 24 Female 104 lb 11/5/2007 Consumer Brazil
Primary
Secondary
Concomitant
Somnolence Other Serious 10/26/2007 65 Male 143 lb 11/6/2007 Consumer Brazil
Primary
Secondary
Syncope Hospitalization 8/1/2007 24 Female 104 lb 11/8/2007 Physician Brazil
Primary
Secondary
Concomitant
Vomiting Other Serious 9/1/2007 8 Male 11/9/2007 Consumer Finland
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 8/1/2007 Male 11/20/2007 Consumer Egypt
Primary
Secondary
Cardiac Failure Death 4/4/2006 76 Male 192 lb 11/27/2007 Physician Switzerland
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 10/1/2007 39 Male 198 lb 11/29/2007 Consumer Brazil
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/8/2007 Female 11/30/2007 Physician Argentina
Primary
Secondary
Concomitant
Vomiting Other Serious 11/23/2007 18 Female 126 lb 12/4/2007 Consumer Brazil
Primary
Secondary
Concomitant
Somnolence Other Serious 10/26/2007 65 Male 143 lb 12/7/2007 Consumer Brazil
Primary
Secondary
Vomiting Other Serious 9/1/2007 8 Male 12/12/2007 Consumer Finland
Primary
Secondary
Concomitant
Weight Decreased Life Threatening 8/25/2007 51 Female 185 lb 12/12/2007 Consumer Turkey
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2003 47 Female 176 lb 12/17/2007 Consumer Turkey
Primary
Secondary
Concomitant
Syncope Hospitalization 8/1/2007 24 Female 104 lb 12/18/2007 Physician Brazil
Primary
Secondary
Concomitant
Visual Disturbance Disability 1/1/2003 51 Male 141 lb 12/28/2007 Consumer Brazil
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 11/23/2007 45 Male 12/28/2007 Other Health Professional Israel
Primary
Secondary
Concomitant
Syncope Other Serious 12/30/2007 53 Female 105 lb 1/10/2008 Consumer Brazil
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 10/1/2007 39 Male 198 lb 1/15/2008 Physician Brazil
Primary
Secondary
Concomitant
Hypoglycaemic Unconsciousness Disability 1/1/2007 53 Female 105 lb 1/16/2008 Consumer Brazil
Primary
Secondary
Concomitant
Screaming Other Serious Male 2/6/2008 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 9/1/2007 8 Male 2/6/2008 Consumer Finland
Primary
Secondary
Concomitant
Solitary Kidney Congenital Anomaly 10/20/2007 Female 10 lb 2/15/2008 Consumer Brazil
Primary
Secondary
Pneumonia Hospitalization 10/1/2007 83 Male 163 lb 2/19/2008 Consumer Brazil
Primary
Secondary
Concomitant
Solitary Kidney Congenital Anomaly 10/20/2007 0 Female 10 lb 2/21/2008 Consumer Brazil
Primary
Secondary
Threatened Labour Hospitalization 29 Female 123 lb 2/21/2008 Consumer Brazil
Primary
Secondary
Screaming Other Serious 6/1/2007 34 Male 2/25/2008 United Kingdom
Primary
Secondary
Concomitant
Threatened Labour Hospitalization 29 Female 123 lb 2/27/2008 Consumer Brazil
Primary
Secondary

Drug Data