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Review Drotrecogin View Drotrecogin Adverse Event Reports: patient, 65 years of age, was diagnosed with sepsis and took Drotrecogin Patient was hospitalized.

Learn What Others Think about Drotrecogin Side Effects. Have Your experienced Drotrecogin Side Effects? You are not alone. Many patients report unusual symptoms after using Drotrecogin. This forum raises awareness about Drotrecogin Side Effects.

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Showing 1-25 of 74 

Multi-organ Failure, Gastrointestinal Haemorrhage (8438939-2)
on Jun 11, 2012 Male patient from UNITED STATES , 65 years of age, was diagnosed with and was treated with Drotrecogin Alfa (activated)(View Usage). Patient experienced the following unwanted or unexpected effects: multi-organ failure, gastrointestinal haemorrhage. Drotrecogin Alfa (activated) dosage: N/A. Patient was hospitalized.

Gastrointestinal Haemorrhage, Multi-organ Failure (8438934-3)
Patient was taking Drotrecogin Alfa (activated) (View Usage). Patient had the following side effects: gastrointestinal haemorrhage, multi-organ failure on Jun 11, 2012 from UNITED STATES Additional patient health information: Male patient , 65 years of age, was diagnosed with and. Drotrecogin Alfa (activated) dosage: N/A. Patient was hospitalized.

Multi-organ Failure, Urogenital Haemorrhage (8438933-1)
Adverse event was reported on Jun 11, 2012 by a Male patient taking Drotrecogin Alfa (activated) (View Usage) (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 65 years of age, After Drotrecogin was administered, patient had the following side effects: multi-organ failure, urogenital haemorrhage. Patient was hospitalized.

Retroperitoneal Haemorrhage, Multi-organ Failure (8438929-X)
on Jun 11, 2012 Male patient from UNITED STATES , 65 years of age, was diagnosed with and was treated with Drotrecogin Alfa (activated) (View Usage). Patient experienced the following unwanted or unexpected effects: retroperitoneal haemorrhage, multi-organ failure. Drotrecogin Alfa (activated) dosage: N/A. Patient was hospitalized.


Gastrointestinal Haemorrhage, Multi-organ Failure (8438927-6)
on Jun 11, 2012 Male patient from UNITED STATES , 65 years of age, was diagnosed with and was treated with Drotrecogin Alfa (activated)(View Usage). Patient had the following side effects: gastrointestinal haemorrhage, multi-organ failure. Drotrecogin Alfa (activated) dosage: N/A. Patient was hospitalized.

Haemorrhage Intracranial, Mouth Haemorrhage, Bradycardia, Cardiac Arrest (7475421-3)
Patient was taking Drotrecogin Alpha /15mg/75ml@14.4ml/hr (View Usage). After Drotrecogin was administered, patient had the following side effects: haemorrhage intracranial, mouth haemorrhage, bradycardia, cardiac arrest (cardiac arrest Questions) on May 10, 2011 from UNITED STATES Additional patient health information: Female patient , 70 years of age, weighting 240.0 lb, was diagnosed with and. Drotrecogin Alpha /15mg/75ml@14.4ml/hr dosage: 15mg/75ml Drip Iv.

Gastric Haemorrhage, Gaze Palsy, Brain Midline Shift, Haemorrhage Intracranial (7357032-3)
Adverse event was reported on Mar 10, 2011 by a Male patient taking Drotrecogin Alfa Eli Lilly (View Usage) (Dosage: 24 Mcg/kg/hour Continue Infusion Iv Drip) was diagnosed with
  • septic shock
and. Location: UNITED STATES , 49 years of age, weighting 166.9 lb, Patient experienced the following unwanted or unexpected effects: gastric haemorrhage, gaze palsy, brain midline shift, haemorrhage intracranial.

Sepsis Syndrome, Bacteraemia, Hypotension, Blood Urea Increased, Blood Creatinine Increased, Scratch, Confusional State, Abdominal Pain, Pasteurella Infection (7312117-2)
on Feb 09, 2011 Female patient from UNITED STATES , 36 years of age, was treated with Drotrecogin Alfa (View Usage). Patient had the following side effects: sepsis syndrome, bacteraemia, hypotension, blood urea increased, blood creatinine increased, scratch, confusional state, abdominal pain (abdominal pain Questions), pasteurella infection. Drotrecogin Alfa dosage: Unk.
Patient was taking other medications: Patient was hospitalized.

Haemorrhage Intracranial, Ischaemic Stroke (7049211-X)
on Oct 12, 2010 Male patient from FRANCE , weighting 127.9 lb, was diagnosed with
  • septic shock
and was treated with Drotrecogin Alfa (activated)(View Usage). After Drotrecogin was administered, patient had the following side effects: haemorrhage intracranial, ischaemic stroke. Drotrecogin Alfa (activated) dosage: 24 D/f, Every Hour.
Patient was taking other medications:

Gastrointestinal Haemorrhage, Haemorrhage Urinary Tract, Hypoxia, Thrombosis, Tracheal Haemorrhage (6979639-5)
Patient was taking Drotrecogin Alfa (View Usage). Patient experienced the following unwanted or unexpected effects: gastrointestinal haemorrhage, haemorrhage urinary tract, hypoxia, thrombosis, tracheal haemorrhage on Sep 10, 2010 from UNITED STATES Additional patient health information: Male patient , 32 years of age, weighting 187.4 lb, was diagnosed with and. Drotrecogin Alfa dosage: Continuous Infusio Iv Drip.

Cerebral Haemorrhage, Pneumothorax (6962593-X)
Adverse event was reported on Aug 29, 2010 by a Male patient taking Drotrecogin Alfa (activated) (View Usage) (Dosage: 24 D/f, Every Hour) was diagnosed with and. Location: AUSTRALIA , weighting 187.4 lb, Patient had the following side effects: cerebral haemorrhage, pneumothorax.
Patient was taking other medications: Patient was hospitalized.

Cerebral Haemorrhage, Local Swelling, Pneumothorax (6958121-5)
on Aug 23, 2010 Male patient from AUSTRALIA , weighting 187.4 lb, was diagnosed with and was treated with Drotrecogin Alfa (activated) (View Usage). After Drotrecogin was administered, patient had the following side effects: cerebral haemorrhage, local swelling, pneumothorax. Drotrecogin Alfa (activated) dosage: 24 D/f, Every Hour.
Patient was taking other medications: Patient was hospitalized.

Peripheral Ischaemia (6922049-7)
on Aug 05, 2010 Male patient from FRANCE , weighting 205.0 lb, was diagnosed with
  • septic shock
  • peritonitis
and was treated with Drotrecogin Alfa (activated)(View Usage). Patient experienced the following unwanted or unexpected effects: peripheral ischaemia. Drotrecogin Alfa (activated) dosage: 24 D/f, Every Hour.
Patient was taking other medications:

Peripheral Ischaemia (6909700-2)
Patient was taking Drotrecogin Alfa (activated) (View Usage). Patient had the following side effects: peripheral ischaemia on Jul 26, 2010 from FRANCE Additional patient health information: Male patient , weighting 205.0 lb, was diagnosed with
  • septic shock
  • peritonitis
and. Drotrecogin Alfa (activated) dosage: 24 D/f, Every Hour.
Patient was taking other medications:

Coagulopathy (6906787-8)
Adverse event was reported on Feb 01, 2010 by a Female patient taking Drotrecogin Alfa (activated) (View Usage) (Dosage: N/A) was diagnosed with
  • septic shock
and. Location: UNITED KINGDOM , 84 years of age, After Drotrecogin was administered, patient had the following side effects: coagulopathy.
Patient was taking other medications:

Acute Myocardial Infarction (6790260-4)
on Dec 01, 2009 Female patient from NETHERLANDS , weighting 110.2 lb, was diagnosed with and was treated with Drotrecogin Alfa (activated) (View Usage). Patient experienced the following unwanted or unexpected effects: acute myocardial infarction. Drotrecogin Alfa (activated) dosage: Unk, Unk.
Patient was taking other medications: Patient was hospitalized.

Blood Pressure Decreased, Infusion Related Reaction, Organ Failure (6737572-8)
on May 21, 2010 Male patient from UNITED STATES , 72 years of age, weighting 136.7 lb, was diagnosed with
  • septic shock
and was treated with Drotrecogin Alfa(View Usage). Patient had the following side effects: blood pressure decreased, infusion related reaction, organ failure. Drotrecogin Alfa dosage: Iv Drip.
Patient was taking other medications:

Brain Herniation, Coagulopathy, Disseminated Intravascular Coagulation, Haemorrhage Intracranial, Respiratory Failure, Septic Shock (6703014-1)
Patient was taking Drotrecogin Alfa (View Usage). After Drotrecogin was administered, patient had the following side effects: brain herniation, coagulopathy, disseminated intravascular coagulation, haemorrhage intracranial, respiratory failure, septic shock on Apr 29, 2010 from UNITED STATES Additional patient health information: Male patient , weighting 205.9 lb, was diagnosed with
  • septic shock
and. Drotrecogin Alfa dosage: 24 Mcg/kg/hr.

Accidental Overdose (6599687-7)
Adverse event was reported on Feb 18, 2010 by a Female patient taking Drotrecogin Alfa (activated) (View Usage) (Dosage: 8900 Ug, Other) was diagnosed with and. Location: UNITED STATES , 22 years of age, Patient experienced the following unwanted or unexpected effects: accidental overdose.

Arrhythmia, Blood Potassium Increased, Bradycardia, Cardiac Arrest, Electrocardiogram Qrs Complex Prolonged, Treatment Failure, Ventricular Fibrillation (6556702-4)
on Jan 22, 2010 Female patient from FRANCE , 74 years of age, weighting 176.4 lb, was diagnosed with
  • septic shock
and was treated with Drotrecogin Alfa (activated) (View Usage). Patient had the following side effects: arrhythmia (arrhythmia Questions), blood potassium increased, bradycardia, cardiac arrest (cardiac arrest Questions), electrocardiogram qrs complex prolonged, treatment failure, ventricular fibrillation. Drotrecogin Alfa (activated) dosage: Unk, Unk.
Patient was taking other medications:

Arrhythmia, Bradycardia, Cardiac Arrest, Electrocardiogram Qrs Complex Prolonged, Hyperkalaemia, Ventricular Fibrillation (6541546-X)
on Dec 10, 2009 Female patient from FRANCE , 74 years of age, weighting 176.4 lb, was diagnosed with
  • septic shock
and was treated with Drotrecogin Alfa (activated)(View Usage). After Drotrecogin was administered, patient had the following side effects: arrhythmia (arrhythmia Questions), bradycardia, cardiac arrest (cardiac arrest Questions), electrocardiogram qrs complex prolonged, hyperkalaemia, ventricular fibrillation. Drotrecogin Alfa (activated) dosage: Unk, Unk.
Patient was taking other medications:

Cardiac Failure, Gastrointestinal Haemorrhage (6506310-6)
Patient was taking Drotrecogin Alfa (activated) (View Usage). Patient experienced the following unwanted or unexpected effects: cardiac failure, gastrointestinal haemorrhage on Dec 14, 2009 from FRANCE Additional patient health information: Male patient , weighting 241.2 lb, was diagnosed with and. Drotrecogin Alfa (activated) dosage: 24 Ug/kg/h.
Patient was taking other medications:

Haemorrhage Intracranial (6500238-3)
Adverse event was reported on Dec 15, 2009 by a Male patient taking Drotrecogin Alfa (View Usage) (Dosage: 24 Mcg/kg/hr) . Location: UNITED STATES , 54 years of age, Patient had the following side effects: haemorrhage intracranial.

Haemorrhagic Stroke (6475163-7)
on Apr 10, 2009 Female patient from FRANCE , weighting 147.7 lb, was diagnosed with and was treated with Drotrecogin Alfa (activated) (View Usage). After Drotrecogin was administered, patient had the following side effects: haemorrhagic stroke. Drotrecogin Alfa (activated) dosage: N/A.
Patient was taking other medications:

Haemorrhage Intracranial (6473422-5)
on Mar 31, 2009 Male patient from FRANCE , weighting 158.7 lb, was diagnosed with
  • septic shock
and was treated with Drotrecogin Alfa (activated)(View Usage). Patient experienced the following unwanted or unexpected effects: haemorrhage intracranial. Drotrecogin Alfa (activated) dosage: Unk, Unk.
Patient was taking other medications:

Showing 1-25 of 74 


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Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit

[Posted 10/25/2011]

AUDIENCE: Critical Care Medicine

ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

BACKGROUND: Xigris is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

RECOMMENDATION: Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris. All remaining Xigris product should be returned to the supplier from whom it was purchased.

[10/25/2011 - Drug Safety Communication - FDA]

 

Previous MedWatch Alert:

[02/04/2009] Xigris - Early Communication about an Ongoing Safety Review
 

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Drotrecogin Adverse Reactions
Haemorrhage Intracranial ( 13 Reports)
Multi-organ Failure ( 12 Reports)
Gastrointestinal Haemorrhage ( 10 Reports)
Haemorrhage ( 8 Reports)
Death ( 6 Reports)
Brain Death ( 4 Reports)
Cardiac Arrest ( 4 Reports) Cardiac arrest Questions
Cerebral Haemorrhage ( 4 Reports)
Coagulopathy ( 4 Reports)
Coma ( 4 Reports)
Septic Shock ( 4 Reports)
Thrombocytopenia ( 4 Reports)
Anaemia ( 3 Reports)
Bradycardia ( 3 Reports)
Gastric Haemorrhage ( 3 Reports)
Peripheral Ischaemia ( 3 Reports)
Subarachnoid Haemorrhage ( 3 Reports)
Acute Respiratory Distress Syndrome ( 2 Reports)
Arrhythmia ( 2 Reports) Arrhythmia Questions
Cardio-respiratory Distress ( 2 Reports)
Cerebrovascular Accident ( 2 Reports)
Electrocardiogram Qrs Complex Prolonged ( 2 Reports)
Faeces Discoloured ( 2 Reports)
Haemodialysis ( 2 Reports)
Haemorrhagic Stroke ( 2 Reports)
Infusion Related Reaction ( 2 Reports)
Localised Intraabdominal Fluid Collection ( 2 Reports)
Meningoencephalitis Bacterial ( 2 Reports)
Mental Status Changes ( 2 Reports)
Pneumothorax ( 2 Reports)

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