Heparin combined with Protamine Sulfate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 8/19/2004 21 9/12/2005 Physician United States
Primary
Concomitant
International Normalised Ratio Increased 2/2/2005 59 9/12/2005 Physician United States
Primary
Concomitant
Intestinal Infarction Death 2/9/2006 78 Male 170 lb 2/16/2006 Physician
Primary
Concomitant
Intracardiac Thrombus Death NotSpecified 2/13/2006 Physician United States
Primary
Secondary
Tachypnoea Death 2/9/2006 78 Male 170 lb 2/20/2006 Physician
Primary
Concomitant
Thrombotic Stroke Disability 4/28/2005 45 Male 2/21/2006 Physician France
Primary
Concomitant
Respiratory Failure Life Threatening 2/1/2006 63 Female 121 lb 2/14/2006 Physician United States
Primary
Concomitant
Rhabdomyolysis Disability 1/4/2006 50 Male 220 lb 2/23/2006 Physician Japan
Primary
Concomitant
Thrombotic Stroke Disability 4/28/2005 45 Male 128 lb 3/4/2006 Physician France
Primary
Concomitant
Renal Impairment Required Intervention 5/25/2005 68 Male 149 lb 3/1/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Required Intervention 9/18/2003 65 Female 155 lb 3/3/2006 Physician United States
Primary
Concomitant
Delayed Recovery From Anaesthesia Hospitalization 4/8/2005 77 Female 3/10/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Stroke Disability 4/28/2005 45 Male 128 lb 3/24/2006 Physician France
Primary
Concomitant
Ventricular Hypokinesia Life Threatening 11/21/2005 62 Female 3/20/2006 Physician United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 5/5/2004 66 Male 225 lb 4/6/2006 Physician United States
Primary
Concomitant
Death Death 5/1/2004 78 Male 161 lb 4/6/2006 Physician United States
Primary
Concomitant
Death Death 3/18/2004 77 Male 207 lb 4/12/2006 Physician United States
Primary
Concomitant
Death Death 4/24/2004 61 Male 181 lb 4/12/2006 Physician United States
Primary
Concomitant
Sinusitis Hospitalization 56 Female 216 lb 4/13/2006 Other Health Professional Australia
Primary
Concomitant
Rhabdomyolysis Life Threatening 6/13/2005 49 Female 265 lb 4/25/2006 Pharmacist United States
Primary
Concomitant
Delayed Recovery From Anaesthesia Hospitalization 12/6/2005 57 Male 148 lb 5/5/2006 Physician Japan
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 74 Female 114 lb 5/18/2006 United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/6/2005 57 Male 148 lb 6/5/2006 Physician Japan
Primary
Concomitant
Intestinal Infarction Death 2/9/2006 78 Male 170 lb 6/30/2006 Physician
Primary
Concomitant
Wound Secretion Other Serious 8/1/2004 74 Female 114 lb 6/29/2006 United States
Primary
Secondary
Concomitant
Renal Failure Life Threatening 12/18/2005 82 Male 185 lb 6/29/2006 United States
Primary
Concomitant
Urine Output Decreased Required Intervention 5/23/2006 60 Male 234 lb 5/30/2006 Pharmacist United States
Primary
Concomitant
Post Procedural Complication Disability 5/12/2006 85 Female 112 lb 5/24/2006 United States
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 74 Female 114 lb 7/18/2006 United States
Primary
Secondary
Concomitant
Postoperative Renal Failure Other Serious 67 Female 139 lb 7/28/2006 Physician Canada
Primary
Secondary
Concomitant
Subclavian Vein Thrombosis Other Serious 8/22/2005 67 Female 159 lb 8/21/2006 Australia
Primary
Concomitant
Vena Cava Thrombosis Death 46 Female 110 lb 9/5/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Wound Other Serious 2/1/2006 Female 176 lb 10/10/2006 Physician Poland
Primary
Concomitant
Haemorrhage Other Serious 8/29/2006 Physician United States
Primary
Secondary
Pulmonary Oedema Hospitalization 45 Female 8/29/2006 Physician United States
Primary
Concomitant
Hypersensitivity Other Serious 8/3/2005 64 Male 201 lb 8/29/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 1/1/2002 8/29/2006 Physician United States
Primary
Concomitant
Hypoperfusion Other Serious 1/1/2002 8/29/2006 Physician United States
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 74 Female 115 lb 10/30/2006 Physician United States
Primary
Secondary
Concomitant
Tachypnoea Death 2/9/2006 78 Male 170 lb 11/6/2006 Physician
Primary
Concomitant
Heart Rate Decreased Death 1/1/2006 87 Male 11/7/2006 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 12/1/2005 83 Male 185 lb 11/7/2006 Physician United States
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 Female 11/9/2006 Consumer Germany
Primary
Secondary
Concomitant
Arterial Thrombosis Other Serious 9/29/2005 64 Male 148 lb 11/13/2006 Physician Australia
Primary
Concomitant
Heart Rate Decreased Death 1/1/2006 87 Male 11/16/2006 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 71 Male 185 lb 11/20/2006 Physician United Kingdom
Primary
Concomitant
Wound Other Serious 2/1/2006 Female 176 lb 11/29/2006 Physician Poland
Primary
Concomitant
Intestinal Infarction Death 2/9/2006 Male 170 lb 11/29/2006 Physician
Primary
Concomitant
Heparin-induced Thrombocytopenia Other Serious 7/2/2006 67 Male 216 lb 8/15/2006 Physician United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 5/20/2005 71 Male 185 lb 12/15/2006 Physician United Kingdom
Primary
Concomitant
Sinus Tachycardia Required Intervention 3 Female 28 lb 12/14/2006 United States
Primary
Concomitant
Vascular Graft Occlusion Other Serious 11/7/2006 62 Male 1/16/2007 Physician United States
Primary
Concomitant
Intracardiac Thrombus Death 75 1/24/2007 Other Health Professional Germany
Primary
Concomitant
Intestinal Infarction Hospitalization 1/31/2006 Male 170 lb 2/7/2007 Physician
Primary
Concomitant
Intracardiac Thrombus Other Serious 2/6/2007 58 Female 2/15/2007 Physician United States
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 10/17/2006 81 Male 143 lb 3/16/2007 Physician Australia
Primary
Concomitant
Renal Vein Thrombosis Other Serious 1 Male 18 lb 3/16/2007 Physician Australia
Primary
Concomitant
Vascular Graft Occlusion Other Serious 11/7/2006 62 Male 3/22/2007 Physician United States
Primary
Concomitant
Haemorrhage Other Serious 1 4/18/2007
Primary
Secondary
Concomitant
Intracardiac Thrombus Other Serious 2/6/2007 58 Female 4/27/2007 Physician United States
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Other Serious 9/30/2006 62 Female 141 lb 6/14/2007 Physician Germany
Primary
Concomitant
Blood Bilirubin Increased Hospitalization 2/28/2006 61 Male 115 lb 7/13/2007 Pharmacist Japan
Primary
Concomitant
Sepsis Hospitalization 65 Female 187 lb 7/20/2007 Physician Australia
Primary
Concomitant
Hypoxic Encephalopathy Other Serious 3/6/2007 40 Male 7/23/2007 Physician Australia
Primary
Concomitant
Thrombosis Disability 17 Female 154 lb 9/7/2007 Physician Canada
Primary
Concomitant
Intracardiac Thrombus Life Threatening 76 Male 137 lb 9/11/2007 United States
Primary
Concomitant
Stent Occlusion Other Serious 4/1/2007 65 Male 157 lb 8/6/2007 Physician United States
Primary
Concomitant
Pulmonary Thrombosis Death 69 Female 143 lb 10/15/2007 Other Health Professional Australia
Primary
Secondary
Pulmonary Thrombosis Death 69 Female 143 lb 10/17/2007 Other Health Professional Australia
Primary
Secondary
Wound Secretion Other Serious 62 Male 172 lb 10/20/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Required Intervention 11/7/2007 71 Male 146 lb 11/12/2007 Physician Germany
Primary
Concomitant
Pleural Effusion Other Serious 6/29/2007 11/16/2007 Physician Australia
Primary
Concomitant
Post Procedural Haemorrhage Life Threatening 7/9/2007 74 Male 12/3/2007 Pharmacist United States
Primary
Concomitant
Soft Tissue Necrosis Hospitalization 83 12/21/2007 United Kingdom
Primary
Secondary
Concomitant
Cerebrovascular Accident Other Serious 11/21/2006 2/14/2008 Physician Canada
Primary
Concomitant
Shunt Occlusion Life Threatening 12/7/2007 57 Female 3/6/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 3/6/2008 Other Health Professional United States
Primary
Concomitant
Respiratory Failure Other Serious 3/11/2008 Other Health Professional United States
Primary
Concomitant
Right Ventricular Failure Life Threatening 2/1/2006 63 Female 121 lb 5/1/2008 Physician United States
Primary
Concomitant
Ventricular Hypokinesia Required Intervention 9/1/2006 50 Male 196 lb 6/9/2008 Physician United States
Primary
Secondary
Concomitant
Pericardial Effusion Required Intervention 9/1/2006 50 Male 196 lb 6/16/2008 Physician United States
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 9/6/2007 33 Male 154 lb 6/24/2008 Physician Australia
Primary
Concomitant
Ventricular Fibrillation Death 5/11/2008 74 Female 110 lb 6/24/2008 Physician Australia
Primary
Concomitant
Haemorrhage Other Serious 50 Male 7/3/2008 Physician France
Primary
Concomitant
Right Ventricular Failure Life Threatening 79 Female 7/23/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiac Arrest Death 3/19/2008 Male 159 lb 8/5/2008 Pharmacist United States
Primary
Secondary
Skin Ulcer Hospitalization 8/4/2008 Female 139 lb 8/7/2008 United States
Primary
Concomitant
Skin Ulcer Hospitalization 9/8/2008 Female 136 lb 9/10/2008 United States
Primary
Concomitant
Skin Ulcer Hospitalization 9/8/2008 Female 136 lb 9/12/2008 United States
Primary
Concomitant
Grand Mal Convulsion Hospitalization 8/27/2008 61 Male 229 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/26/2008 83 Male 139 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/25/2008 79 Male 134 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/28/2008 67 Female 121 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Ventricular Hypokinesia Life Threatening 6/2/2004 6 Male 11/5/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/27/2008 61 Male 229 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Product Quality Issue Hospitalization 8/26/2008 83 Male 139 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/25/2008 79 Male 134 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/28/2008 67 Female 121 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Hemiparesis Other Serious 9/2/2008 81 Female 101 lb 11/25/2008 Pharmacist United States
Primary
Concomitant
Partial Seizures Other Serious 10/22/2008 61 Female 220 lb 11/26/2008 Pharmacist United States
Primary
Concomitant
Encephalopathy Other Serious 11/10/2008 85 Female 104 lb 11/26/2008 Pharmacist United States
Primary
Secondary
Concomitant
Post Procedural Complication Other Serious 11/18/2008 77 Female 185 lb 11/26/2008 Pharmacist United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 10/29/2008 78 Female 110 lb 11/26/2008 Pharmacist United States
Primary
Concomitant
Myoclonic Epilepsy Other Serious 10/10/2008 69 Female 137 lb 11/26/2008 Pharmacist United States
Primary
Secondary
Concomitant
Troponin Increased Death 11/1/2008 Male 188 lb 3/12/2009 Pharmacist United States
Primary
Secondary
Concomitant
Tardive Dyskinesia Other Serious 8/10/2000 57 Male 344 lb 4/3/2009 Other Health Professional United States
Primary
Concomitant
Pulmonary Embolism Hospitalization 12/17/2008 71 Male 4/20/2009 Physician Australia
Primary
Concomitant
Dressler's Syndrome Hospitalization 11/27/2008 64 Female 172 lb 4/20/2009 Physician Australia
Primary
Concomitant
Paraesthesia Hospitalization 4/10/2009 Male 170 lb 4/13/2009 United States
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 6/19/2008 74 Male 201 lb 5/14/2009 Other Health Professional Australia
Primary
Concomitant
Skin Ulcer Hospitalization 5/19/2009 Male 203 lb 5/20/2009 Consumer United States
Primary
Secondary
Concomitant
Peripheral Ischaemia Hospitalization 6 Male 57 lb 6/10/2009 Physician Australia
Primary
Concomitant
Heart Rate Decreased Required Intervention 4/18/2008 45 Female 248 lb 6/1/2009 Pharmacist United States
Primary
Concomitant
Drug Hypersensitivity Required Intervention 10/27/2005 75 Female 6/1/2009 Consumer United States
Primary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 7/28/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 9/21/2009 Male 166 lb 9/23/2009 Consumer United States
Primary
Concomitant
Pyrexia Other Serious 69 Male 11/13/2009 Physician Australia
Primary
Secondary
Concomitant
Retroperitoneal Haemorrhage Life Threatening 8/19/2009 Female 88 lb 12/8/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Life Threatening 8/19/2009 81 Female 88 lb 1/4/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 12/15/2009 Female 51 lb 2/10/2010 Physician Germany
Primary
Secondary
Concomitant
White Blood Cell Count Increased Life Threatening 8/19/2009 81 Female 88 lb 2/18/2010 Physician Japan
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 2/24/2010 United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 3/5/2010 United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 3/18/2010 Physician United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 3/31/2010 Physician United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 4/13/2010 Physician United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 25 Male 265 lb 4/15/2010 Other Health Professional Germany
Primary
Concomitant
Septic Shock Other Serious 25 Male 265 lb 4/20/2010 Other Health Professional Germany
Primary
Concomitant
Septic Shock Other Serious 25 Male 265 lb 4/27/2010 Other Health Professional Germany
Primary
Concomitant
Septic Shock Other Serious 25 Male 265 lb 4/30/2010 Other Health Professional Germany
Primary
Concomitant
Septic Shock Other Serious 25 Male 265 lb 5/3/2010 Other Health Professional Germany
Primary
Concomitant
Septic Shock Other Serious 25 Male 265 lb 5/7/2010 Other Health Professional Germany
Primary
Concomitant
Wound Drainage Other Serious 2/1/2002 63 Male 140 lb 6/11/2010 Physician United States
Primary
Secondary
Concomitant
Wound Drainage Other Serious 2/1/2002 63 Male 140 lb 6/23/2010 Physician United States
Primary
Secondary
Concomitant
Coagulation Time Prolonged 78 Male 130 lb 6/24/2010 Other Health Professional United States
Primary
Concomitant
Wound Infection Staphylococcal Hospitalization 8/5/2010 68 Male 183 lb 8/16/2010 Physician United States
Primary
Concomitant
Wound Drainage Other Serious 2/1/2002 63 Male 140 lb 8/26/2010 Physician United States
Primary
Secondary
Concomitant
Wound Infection Staphylococcal Hospitalization 8/5/2010 68 Male 183 lb 9/22/2010 Physician United States
Primary
Concomitant
Wound Infection Staphylococcal Hospitalization 8/5/2010 68 Male 183 lb 10/12/2010 Physician United States
Primary
Concomitant
Oxygen Saturation Decreased Hospitalization 5/5/2010 67 Male 1/3/2011 Consumer France
Primary
Secondary
Concomitant
Convulsion Other Serious 1/10/2011 Other Health Professional Turkey
Primary
Concomitant
Haemorrhage Intracranial Other Serious 1/10/2011 Other Health Professional Turkey
Primary
Concomitant
Multi-organ Failure Life Threatening 1/6/2011 79 Male 150 lb 1/18/2011 Physician Chile
Primary
Secondary
Concomitant
Unresponsive To Stimuli Death 10/25/2010 65 Female 156 lb 1/24/2011 Pharmacist United States
Primary
Concomitant
Pain Hospitalization 12/2/1999 73 Male 160 lb 2/24/2011 Consumer United States
Primary
Concomitant
Fear Hospitalization 7/19/2006 71 Male 208 lb 2/24/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Fear Other Serious 7/19/2006 71 Male 208 lb 2/24/2011 Lawyer United States
Primary
Secondary
Concomitant
Emotional Distress Other Serious 5/30/2007 80 Female 127 lb 2/28/2011 Other Health Professional United States
Primary
Concomitant
Klebsiella Sepsis Other Serious 4/15/2000 73 Male 160 lb 2/28/2011 Other Health Professional United States
Primary
Concomitant
Depression Death 4/15/2000 73 Male 160 lb 2/28/2011 Consumer United States
Primary
Concomitant

Drug Data