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Drotrecogin Side Effects

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Common Drotrecogin Side Effects


The most commonly reported Drotrecogin side effects (click to view or check a box to report):

Haemorrhage Intracranial (13)
Multi-organ Failure (12)
Gastrointestinal Haemorrhage (10)
Haemorrhage (8)
Death (6)
Coagulopathy (4)
Brain Death (4)
Cardiac Arrest (4)
Cerebral Haemorrhage (4)
Coma (4)
Thrombocytopenia (4)
Septic Shock (4)
Bradycardia (3)
Anaemia (3)
Gastric Haemorrhage (3)
Peripheral Ischaemia (3)
Subarachnoid Haemorrhage (3)
Meningoencephalitis Bacterial (2)
Infusion Related Reaction (2)
Localised Intraabdominal Fluid Collection (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Drotrecogin Side Effects Reported to FDA



Drotrecogin Side Effect Report#9282098
Cardiogenic Shock, Acidosis, Conjunctival Haemorrhage, Ecchymosis
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: sepsis, who was treated with Drotrecogin Alfa (dosage: 24mcg/kg/hr Continous Iv, start time:
Apr 03, 2011), combined with:
  • Pendex
  • Docusate
  • Senna
  • Fentanyl
  • Phenyephrine
  • Rifaximin
  • Metroxioazole
  • Norepinephrine
and developed a serious reaction and side effect(s): Cardiogenic Shock, Acidosis, Conjunctival Haemorrhage, Ecchymosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa treatment in male patients, resulting in Cardiogenic Shock side effect.
Drotrecogin Side Effect Report#8438939-2
Multi-organ Failure, Gastrointestinal Haemorrhage
This report suggests a potential Drotrecogin Alfa (activated) Multi-organ Failure side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: sepsis and used Drotrecogin Alfa (activated) (dosage: NA) starting NS. After starting Drotrecogin Alfa (activated) the patient began experiencing various side effects, including: Multi-organ Failure, Gastrointestinal HaemorrhageAdditional drugs used concurrently: NA.The patient was hospitalized. Although Drotrecogin Alfa (activated) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Multi-organ Failure, may still occur.
Drotrecogin Side Effect Report#8438934-3
Gastrointestinal Haemorrhage, Multi-organ Failure
This Gastrointestinal Haemorrhage problem was reported by a physician from United States. A 65-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On NS this consumer started treatment with Drotrecogin Alfa (activated) (dosage: NA). The following drugs were being taken at the same time: NA. When using Drotrecogin Alfa (activated), the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Haemorrhage, Multi-organ FailureThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrointestinal Haemorrhage, may become evident only after a product is in use by the general population.
Drotrecogin Side Effect Report#8438933-1
Multi-organ Failure, Urogenital Haemorrhage
This Death side effect was reported by a physician from United States. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: sepsis.The patient was prescribed Drotrecogin Alfa (activated) (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Drotrecogin Alfa (activated) the consumer reported adverse symptoms, such as: Multi-organ Failure, Urogenital HaemorrhageThese side effects may potentially be related to Drotrecogin Alfa (activated). The patient was hospitalized.
Drotrecogin Side Effect Report#8438929-X
Retroperitoneal Haemorrhage, Multi-organ Failure
This is a report of a 65-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: sepsis, who was treated with Drotrecogin Alfa (activated) (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Retroperitoneal Haemorrhage, Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa (activated) treatment in male patients, resulting in Retroperitoneal Haemorrhage side effect. The patient was hospitalized.
Drotrecogin Side Effect Report#8438927-6
Gastrointestinal Haemorrhage, Multi-organ Failure
This report suggests a potential Drotrecogin Alfa (activated) Death side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: sepsis and used Drotrecogin Alfa (activated) (dosage: NA) starting NS. After starting Drotrecogin Alfa (activated) the patient began experiencing various side effects, including: Gastrointestinal Haemorrhage, Multi-organ FailureAdditional drugs used concurrently: NA.The patient was hospitalized. Although Drotrecogin Alfa (activated) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Drotrecogin Side Effect Report#7475421-3
Haemorrhage Intracranial, Mouth Haemorrhage, Bradycardia, Cardiac Arrest, Haemorrhage
This Haemorrhage Intracranial problem was reported by a pharmacist from United States. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Apr 23, 2011 this consumer started treatment with Drotrecogin Alpha /15mg/75ml@14.4ml/hr (dosage: 15mg/75ml Drip Iv). The following drugs were being taken at the same time: NA. When using Drotrecogin Alpha /15mg/75ml@14.4ml/hr, the patient experienced the following unwanted symptoms/side effects: Haemorrhage Intracranial, Mouth Haemorrhage, Bradycardia, Cardiac Arrest, HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage Intracranial, may become evident only after a product is in use by the general population.
Drotrecogin Side Effect Report#7357032-3
Gastric Haemorrhage, Gaze Palsy, Brain Midline Shift, Haemorrhage Intracranial
This Gastric Haemorrhage side effect was reported by a pharmacist from United States. A 49-year-old male patient (weight:NA) experienced the following symptoms/conditions: septic shock.The patient was prescribed Drotrecogin Alfa Eli Lilly (drug dosage: 24 Mcg/kg/hour Continue Infusion Iv Drip), which was initiated on
Mar 04, 2011. Concurrently used drugs: NA..After starting to take Drotrecogin Alfa Eli Lilly the consumer reported adverse symptoms, such as: Gastric Haemorrhage, Gaze Palsy, Brain Midline Shift, Haemorrhage IntracranialThese side effects may potentially be related to Drotrecogin Alfa Eli Lilly.
Drotrecogin Side Effect Report#7312117-2
Sepsis Syndrome, Bacteraemia, Hypotension, Blood Urea Increased, Blood Creatinine Increased, Scratch, Confusional State, Abdominal Pain, Pasteurella Infection
This is a report of a 36-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Drotrecogin Alfa (dosage: Unk, start time: NS), combined with:
  • Gentamicin
  • Hydroxychloroquine
  • Prednisone
  • Vancomycin
and developed a serious reaction and side effect(s): Sepsis Syndrome, Bacteraemia, Hypotension, Blood Urea Increased, Blood Creatinine Increased, Scratch, Confusional State, Abdominal Pain, Pasteurella Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa treatment in female patients, resulting in Sepsis Syndrome side effect. The patient was hospitalized.
Drotrecogin Side Effect Report#7049211-X
Haemorrhage Intracranial, Ischaemic Stroke
This report suggests a potential Drotrecogin Alfa (activated) Haemorrhage Intracranial side effect(s) that can have serious consequences. A male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: septic shock and used Drotrecogin Alfa (activated) (dosage: 24 D/f, Every Hour) starting
Apr 02, 2010. After starting Drotrecogin Alfa (activated) the patient began experiencing various side effects, including: Haemorrhage Intracranial, Ischaemic StrokeAdditional drugs used concurrently:
  • Norepinephrine
  • Cefotaxime Sodium
  • Morphine
  • Midazolam
  • Hydrocortisone
  • Cisatracurium
Although Drotrecogin Alfa (activated) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemorrhage Intracranial, may still occur.
Drotrecogin Side Effect Report#6979639-5
Gastrointestinal Haemorrhage, Haemorrhage Urinary Tract, Hypoxia, Thrombosis, Tracheal Haemorrhage
This Gastrointestinal Haemorrhage problem was reported by a pharmacist from United States. A 32-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Aug 31, 2010 this consumer started treatment with Drotrecogin Alfa (dosage: Continuous Infusio Iv Drip). The following drugs were being taken at the same time: NA. When using Drotrecogin Alfa, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Haemorrhage, Haemorrhage Urinary Tract, Hypoxia, Thrombosis, Tracheal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrointestinal Haemorrhage, may become evident only after a product is in use by the general population.
Drotrecogin Side Effect Report#6962593-X
Cerebral Haemorrhage, Pneumothorax
This Cerebral Haemorrhage side effect was reported by a physician from Australia. A male patient (weight:NA) experienced the following symptoms/conditions: septic shock,sepsis,abscess.The patient was prescribed Drotrecogin Alfa (activated) (drug dosage: 24 D/f, Every Hour), which was initiated on
Aug 23, 2010. Concurrently used drugs:
  • Hydrocortisone
  • Lincomycin
  • Tazocin
  • Ciprofloxacin
  • Magnesium Sulphate /00167401/
  • Noradrenaline (45 Ug, Other)
  • Midazolam Hcl
  • Propofol
.After starting to take Drotrecogin Alfa (activated) the consumer reported adverse symptoms, such as: Cerebral Haemorrhage, PneumothoraxThese side effects may potentially be related to Drotrecogin Alfa (activated). The patient was hospitalized.
Drotrecogin Side Effect Report#6958121-5
Cerebral Haemorrhage, Local Swelling, Pneumothorax
This is a report of a male patient (weight: NA) from Australia, suffering from the following health symptoms/conditions: septic shock,sepsis,abscess, who was treated with Drotrecogin Alfa (activated) (dosage: 24 D/f, Every Hour, start time:
Aug 23, 2010), combined with:
  • Hydrocortisone
  • Lincomycin
  • Tazocin
  • Ciprofloxacin
  • Magnesium Sulphate /00167401/
  • Noradrenaline (45 Ug, Other)
  • Midazolam Hcl
  • Propofol
and developed a serious reaction and side effect(s): Cerebral Haemorrhage, Local Swelling, Pneumothorax after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa (activated) treatment in male patients, resulting in Cerebral Haemorrhage side effect. The patient was hospitalized.
Drotrecogin Side Effect Report#6922049-7
Peripheral Ischaemia
This report suggests a potential Drotrecogin Alfa (activated) Peripheral Ischaemia side effect(s) that can have serious consequences. A male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: septic shock,peritonitis and used Drotrecogin Alfa (activated) (dosage: 24 D/f, Every Hour) starting
May 03, 2010. After starting Drotrecogin Alfa (activated) the patient began experiencing various side effects, including: Peripheral IschaemiaAdditional drugs used concurrently:
  • Piperacillin W/tazobactam
  • Norepinephrine Bitartrate
  • Fenatyl
  • Midazolam Hcl
  • Aspirine
  • Heparin
  • Insuline
  • Nefopam
Although Drotrecogin Alfa (activated) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Peripheral Ischaemia, may still occur.
Drotrecogin Side Effect Report#6909700-2
Peripheral Ischaemia
This Peripheral Ischaemia problem was reported by a physician from France. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: septic shock,peritonitis. On
May 03, 2010 this consumer started treatment with Drotrecogin Alfa (activated) (dosage: 24 D/f, Every Hour). The following drugs were being taken at the same time:
  • Piperacillin W/tazobactam
  • Norepinephrine Bitartrate
  • Fenatyl
  • Midazolam Hcl
  • Aspirine
  • Heparin
  • Insuline
  • Nefopam
When using Drotrecogin Alfa (activated), the patient experienced the following unwanted symptoms/side effects: Peripheral IschaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Peripheral Ischaemia, may become evident only after a product is in use by the general population.
Drotrecogin Side Effect Report#6906787-8
Coagulopathy
This Coagulopathy side effect was reported by a physician from United Kingdom. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: septic shock.The patient was prescribed Drotrecogin Alfa (activated) (drug dosage: NA), which was initiated on
Jan 17, 2010. Concurrently used drugs:
  • Amiodarone Hcl
  • Dobutamine Hcl
  • Enoxaparin Sodium
  • Esomeprazole Magnesium
  • Noradrenaline
  • Tazocin
.After starting to take Drotrecogin Alfa (activated) the consumer reported adverse symptoms, such as: CoagulopathyThese side effects may potentially be related to Drotrecogin Alfa (activated).
Drotrecogin Side Effect Report#6790260-4
Acute Myocardial Infarction
This is a report of a female patient (weight: NA) from Netherlands, suffering from the following health symptoms/conditions: septic shock,hypotension,sedation,hyperglycaemia,pain,bronchospasm,sepsis,thrombosis prophylaxis, who was treated with Drotrecogin Alfa (activated) (dosage: Unk, Unk, start time:
Nov 28, 2009), combined with:
  • Norepinephrine (2 Ug, Every Min)
  • Propofol (160 Mg, Every Hour)
  • Actrapid /00030501/ (3.5 Iu, Every Hour)
  • Morphine (2 Mg, Every Hour)
  • Berodual (200 Ug, Daily (1/d))
  • Ciprofloxacin (5700 Mg, Daily (1/d))
  • Enoxaparin
  • Kefzol
and developed a serious reaction and side effect(s): Acute Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa (activated) treatment in female patients, resulting in Acute Myocardial Infarction side effect. The patient was hospitalized.
Drotrecogin Side Effect Report#6737572-8
Blood Pressure Decreased, Infusion Related Reaction, Organ Failure
This report suggests a potential Drotrecogin Alfa Blood Pressure Decreased side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: septic shock and used Drotrecogin Alfa (dosage: Iv Drip) starting
Apr 07, 2010. After starting Drotrecogin Alfa the patient began experiencing various side effects, including: Blood Pressure Decreased, Infusion Related Reaction, Organ FailureAdditional drugs used concurrently:
  • Cefepime
  • Vancomycin
  • Levofloxacin
  • Pantoprazole
  • Insulin
  • Norepinephrine
  • Vasopressin
Although Drotrecogin Alfa demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Decreased, may still occur.
Drotrecogin Side Effect Report#6703014-1
Brain Herniation, Coagulopathy, Disseminated Intravascular Coagulation, Haemorrhage Intracranial, Respiratory Failure, Septic Shock
This Brain Herniation problem was reported by a pharmacist from United States. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: septic shock. On
Mar 30, 2010 this consumer started treatment with Drotrecogin Alfa (dosage: 24 Mcg/kg/hr). The following drugs were being taken at the same time: NA. When using Drotrecogin Alfa, the patient experienced the following unwanted symptoms/side effects: Brain Herniation, Coagulopathy, Disseminated Intravascular Coagulation, Haemorrhage Intracranial, Respiratory Failure, Septic ShockAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Brain Herniation, may become evident only after a product is in use by the general population.
Drotrecogin Side Effect Report#6599687-7
Accidental Overdose
This Accidental Overdose side effect was reported by a physician from United States. A 22-year-old female patient (weight:NA) experienced the following symptoms/conditions: meningitis.The patient was prescribed Drotrecogin Alfa (activated) (drug dosage: 8900 Ug, Other), which was initiated on NS. Concurrently used drugs: NA..After starting to take Drotrecogin Alfa (activated) the consumer reported adverse symptoms, such as: Accidental OverdoseThese side effects may potentially be related to Drotrecogin Alfa (activated).
Drotrecogin Side Effect Report#6556702-4
Arrhythmia, Blood Potassium Increased, Bradycardia, Cardiac Arrest, Electrocardiogram Qrs Complex Prolonged, Treatment Failure, Ventricular Fibrillation
This is a report of a 74-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: septic shock, who was treated with Drotrecogin Alfa (activated) (dosage: Unk, Unk, start time:
Dec 09, 2009), combined with:
  • Epinephrine
  • Midazolam Hcl
  • Fentanyl
  • Insulin
  • Paracetamol
  • Imipenem
  • Hydrocortisone
  • Amiodarone
and developed a serious reaction and side effect(s): Arrhythmia, Blood Potassium Increased, Bradycardia, Cardiac Arrest, Electrocardiogram Qrs Complex Prolonged, Treatment Failure, Ventricular Fibrillation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa (activated) treatment in female patients, resulting in Arrhythmia side effect.
Drotrecogin Side Effect Report#6541546-X
Arrhythmia, Bradycardia, Cardiac Arrest, Electrocardiogram Qrs Complex Prolonged, Hyperkalaemia, Ventricular Fibrillation
This report suggests a potential Drotrecogin Alfa (activated) Arrhythmia side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: septic shock and used Drotrecogin Alfa (activated) (dosage: Unk, Unk) starting
Dec 09, 2009. After starting Drotrecogin Alfa (activated) the patient began experiencing various side effects, including: Arrhythmia, Bradycardia, Cardiac Arrest, Electrocardiogram Qrs Complex Prolonged, Hyperkalaemia, Ventricular FibrillationAdditional drugs used concurrently:
  • Epinephrine
  • Midazolam Hcl
  • Fentanyl
  • Insulin
  • Paracetamol
  • Imipenem
  • Hydrocortisone
  • Amiodarone
Although Drotrecogin Alfa (activated) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Arrhythmia, may still occur.
Drotrecogin Side Effect Report#6506310-6
Cardiac Failure, Gastrointestinal Haemorrhage
This Cardiac Failure problem was reported by a physician from France. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Mar 30, 2009 this consumer started treatment with Drotrecogin Alfa (activated) (dosage: 24 Ug/kg/h). The following drugs were being taken at the same time:
  • Tavanic
  • Rocephin
  • Gentalline
  • Hypnovel
  • Sufentanil Citrate
  • Diprivan
  • Actrapid /00030501/
When using Drotrecogin Alfa (activated), the patient experienced the following unwanted symptoms/side effects: Cardiac Failure, Gastrointestinal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cardiac Failure, may become evident only after a product is in use by the general population.
Drotrecogin Side Effect Report#6500238-3
Haemorrhage Intracranial
This Haemorrhage Intracranial side effect was reported by a pharmacist from United States. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Drotrecogin Alfa (drug dosage: 24 Mcg/kg/hr), which was initiated on NS. Concurrently used drugs: NA..After starting to take Drotrecogin Alfa the consumer reported adverse symptoms, such as: Haemorrhage IntracranialThese side effects may potentially be related to Drotrecogin Alfa.
Drotrecogin Side Effect Report#6475163-7
Haemorrhagic Stroke
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: sepsis, who was treated with Drotrecogin Alfa (activated) (dosage: NA, start time:
Dec 31, 2007), combined with:
  • Heparin
  • Hypnovel
  • Sufentanil Citrate
  • Glucor
  • Glibenclamide
  • Metformin Hcl
  • Kardegic
  • Pravastatin
and developed a serious reaction and side effect(s): Haemorrhagic Stroke after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Drotrecogin Alfa (activated) treatment in female patients, resulting in Haemorrhagic Stroke side effect.


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The appearance of Drotrecogin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Drotrecogin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Drotrecogin Safety Alerts, Active Ingredients, Usage Information

    More About Drotrecogin

    Side Effects reported to FDA: 75

    Drotrecogin safety alerts: 2011 2009 2005

    Reported deaths: 29

    Reported hospitalizations: 10

    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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