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Xigris (Drotrecogin Alfa) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xigris (Drotrecogin Alfa) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (11)
Death (6)

Reports by Reaction Type

Brain Death (2)Death (2)Finger Amputation (2)Brain Oedema (2)Immune System Disorder (2)Septic Shock (2)Disseminated Intravascular Coagulation (1)Cerebral Haemorrhage (1)Multi-Organ Failure (1)Myocardial Infarction (1)International Normalised Ratio Increased (1)General Physical Health Deterioration (1)

Possible Xigris side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-08

Patient: female

Reactions: Finger Amputation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xigris

Other drugs received by patient: Penicillin G; Clindamycin



Possible Xigris side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-13

Patient: male

Reactions: Immune System Disorder

Drug(s) suspected as cause:
Xigris



Possible Xigris side effects in 47 year old male

Reported by a physician from United States on 2012-01-12

Patient: 47 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Immunoglobulins Decreased, Eosinophilic Oesophagitis, Bursitis, Immune System Disorder, Autoimmune Neuropathy, Plantar Fasciitis

Drug(s) suspected as cause:
Xigris



Possible Xigris side effects in 20 year old female

Reported by a physician from United States on 2011-12-13

Patient: 20 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xigris

Other drugs received by patient: Vancomycin; Levophed; Dopamine HCL; Rocephin



Possible Xigris side effects in male

Reported by a physician from Poland on 2011-12-07

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Brain Death, Haemorrhage Intracranial, Brain Oedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xigris



Possible Xigris side effects in male

Reported by a physician from Poland on 2011-12-07

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Brain Death, Death, Brain Oedema, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xigris



Possible Xigris side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-24

Patient: female

Reactions: Finger Amputation

Drug(s) suspected as cause:
Xigris



Possible Xigris side effects in 54 year old male

Reported by a physician from India on 2011-11-11

Patient: 54 year old male

Reactions: Multi-Organ Failure, International Normalised Ratio Increased, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xigris

Other drugs received by patient: Antibiotics



Possible Xigris side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Death

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xigris



Possible Xigris side effects in 49 year old male

Reported by a physician from United States on 2011-10-27

Patient: 49 year old male

Reactions: Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xigris

Other drugs received by patient: Proton Pump Inhibitors; Antibiotics FOR Topical USE; Antibiotics



Possible Xigris side effects in 35 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-26

Patient: 35 year old male, weighing 63.5 kg (139.7 pounds)

Reactions: Renal Failure, Respiratory Failure, Disseminated Intravascular Coagulation, Platelet Count Decreased, General Physical Health Deterioration, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xigris

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