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Curosurf (Poractant Alfa) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Curosurf (Poractant 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 (16)
Death (5)
Life Threatening Events (2)

Reports by Reaction Type

C-Reactive Protein Increased (4)Pulmonary Haemorrhage (4)Drug Ineffective (3)Oxygen Saturation Decreased (3)Shock (3)Disseminated Intravascular Coagulation (2)Expired Drug Administered (2)Pallor (2)Thrombocytopenia (2)Product Quality Issue (2)Dyspnoea (2)Interleukin Level Increased (2)

Possible Curosurf side effects in

Reported by a physician from Mexico on 2012-07-13

Patient:

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in

Reported by a physician from Germany on 2012-07-11

Patient:

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in

Reported by a physician from Mexico on 2012-06-27

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in

Reported by a physician from Mexico on 2012-06-07

Patient:

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in male

Reported by a individual with unspecified qualification from United States on 2012-05-01

Patient: male, weighing 0.8 kg (1.8 pounds)

Reactions: Pulmonary Interstitial Emphysema Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in male

Reported by a health professional (non-physician/pharmacist) from Finland on 2012-04-18

Patient: male

Reactions: Drug Administered AT Inappropriate Site, Pulmonary Haemorrhage, Swelling, Injection Site Swelling, Fluid Retention

Drug(s) suspected as cause:
Numeta G13e
    Start date: 2012-02-20

Curosurf

Other drugs received by patient: Tomycin; Penicillin G



Possible Curosurf side effects in

Reported by a physician from India on 2012-01-05

Patient:

Reactions: Expired Drug Administered

Adverse event resulted in: death

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in male

Reported by a physician from China on 2012-01-04

Patient: male

Reactions: Peripheral Coldness, Dyspnoea, Rales, Erythema, Pallor, Poor Peripheral Circulation, Sepsis, Oxygen Saturation Decreased, Shock, Infantile Apnoeic Attack

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Curosurf

Other drugs received by patient: Etamsilate (Etamsilate); Cefotiam (Cefotiam); Mezlocillin (Mezlocillin); Ambroxol (Ambroxol)



Possible Curosurf side effects in male

Reported by a physician from China on 2012-01-04

Patient: male

Reactions: LOW Birth Weight Baby, Anaemia Neonatal, Neonatal Respiratory Distress Syndrome, Metabolic Acidosis, Neonatal Pneumonia, Disseminated Intravascular Coagulation, Hyperglycaemia, Jaundice Neonatal, Pulmonary Haemorrhage, Cardio-Respiratory Arrest, Hypocalcaemia, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Piperacillin W / Sulbactam Sodium (NO Pref. Name)
    Dosage: daily dose 0.18 grams;twice a day
    Indication: Pneumonia
    Start date: 2011-09-19
    End date: 2011-09-23

Curosurf
    Dosage: daily dose 240 milligrams;daily
    Indication: Neonatal Respiratory Distress Syndrome
    Start date: 2011-09-19
    End date: 2011-09-20

Other drugs received by patient: Haemocoagulase (Haemocoagulase); Etamsilate (Etamsilate); Phenobarbital TAB; Cefodizime (Cefodizime)



Possible Curosurf side effects in male

Reported by a physician from China on 2012-01-04

Patient: male

Reactions: Pulmonary Haemorrhage, Disseminated Intravascular Coagulation

Drug(s) suspected as cause:
Curosurf

Other drugs received by patient: Haemocoagulase (Haemocoagulase); Cefotiam (Cefotiam); Furbencillin Sodium (NO Pref. Name); Antiinfectives (Antiinfectives); Vitamin K NOS (Vitamin K Nos)



Possible Curosurf side effects in female

Reported by a physician from China on 2012-01-04

Patient: female

Reactions: Dyspnoea, Pallor, Oxygen Saturation Decreased, Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Curosurf
    Dosage: daily dose 120 milligrams;unknown
    Indication: Neonatal Respiratory Distress Syndrome Prophylaxis
    Start date: 2011-11-07
    End date: 2011-11-07

Curosurf
    Dosage: daily dose 120 milligrams;unknown
    Indication: Oxygen Saturation Abnormal
    Start date: 2011-11-07
    End date: 2011-11-07

Other drugs received by patient: Mezlocillin (Mezlocillin); Etamsilate (Etamsilate); Cefotiam (Cefotiam); Oxygen (Oxygen); Ambroxol (Ambroxol)



Possible Curosurf side effects in

Reported by a physician from India on 2011-12-16

Patient:

Reactions: Incorrect Route of Drug Administration, Expired Drug Administered

Adverse event resulted in: death

Drug(s) suspected as cause:
Curosurf



Possible Curosurf side effects in female

Reported by a physician from Germany on 2011-11-03

Patient: female

Reactions: C-Reactive Protein Increased, Respiratory Failure

Drug(s) suspected as cause:
Curosurf

Other drugs received by patient: Valproic Acid; Ampicillin; Cefotaxime Sodium



Possible Curosurf side effects in male

Reported by a physician from Germany on 2011-11-03

Patient: male

Reactions: Conjunctivitis, Interleukin Level Increased, Hyperbilirubinaemia Neonatal, C-Reactive Protein Increased, Bradycardia, Apnoea, Thrombocytopenia, Oxygen Saturation Decreased, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Curosurf

Other drugs received by patient: Ecolicin; Solutions FOR Parenteral Nutrition; Caffeine Citrate



Possible Curosurf side effects in female

Reported by a physician from Germany on 2011-10-11

Patient: female

Reactions: C-Reactive Protein Increased

Drug(s) suspected as cause:
Curosurf

Other drugs received by patient: Cefotaxime; Ampicillin Sodium



Possible Curosurf side effects in male

Reported by a physician from Germany on 2011-10-11

Patient: male

Reactions: C-Reactive Protein Increased, Thrombocytopenia, Interleukin Level Increased, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Curosurf

Other drugs received by patient: Solutions FOR Parenteral Nutrition

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