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Prolastin (Alpha 1-Antitrypsin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prolastin (Alpha 1-Antitrypsin) 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)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Chills (2)Anaphylactic Shock (2)Influenza Like Illness (2)Malaise (2)Infusion Related Reaction (2)Drug Hypersensitivity (2)Dermatitis Allergic (1)Hypersensitivity (1)Nasopharyngitis (1)Urticaria (1)Weight Increased (1)Palpitations (1)

Possible Prolastin side effects in 53 year old female

Reported by a pharmacist from United States on 2012-05-11

Patient: 53 year old female, weighing 57.1 kg (125.7 pounds)

Reactions: Anxiety, Pruritus, Blood Potassium Decreased, Joint Swelling, Palpitations, Oedema Peripheral, Rash Maculo-Papular, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolastin
    Dosage: 3513 mg;qw;iv
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2012-04-30
    End date: 2012-04-30

Diphenhydramine HCL
    Dosage: po
    Administration route: Oral
    Indication: Rash
    Start date: 2012-05-01

Diphenhydramine HCL
    Dosage: po
    Administration route: Oral
    Indication: Pruritus
    Start date: 2012-05-01

Corticosteroids
    Indication: Pruritus
    Start date: 2012-05-01
    End date: 2012-05-01

Corticosteroids
    Indication: Rash
    Start date: 2012-05-01
    End date: 2012-05-01



Possible Prolastin side effects in 51 year old male

Reported by a physician from Germany on 2012-04-27

Patient: 51 year old male

Reactions: Glioblastoma, Convulsion

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Forair / 00958002 /; Prednisone; Spiriva



Possible Prolastin side effects in 32 year old female

Reported by a pharmacist from Canada on 2012-04-19

Patient: 32 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Weight Increased

Drug(s) suspected as cause:
Prolastin



Possible Prolastin side effects in 56 year old female

Reported by a pharmacist from Germany on 2012-04-19

Patient: 56 year old female

Reactions: Dermatitis Allergic, Urticaria

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Berodual; Fluticasone Propionate / Salmeterol; Calcimagon / 00751501 /; Prednisone TAB



Possible Prolastin side effects in 51 year old female

Reported by a pharmacist from Portugal on 2012-04-19

Patient: 51 year old female

Reactions: Rash Erythematous

Drug(s) suspected as cause:
Prolastin



Possible Prolastin side effects in 50 year old female

Reported by a pharmacist from United States on 2012-04-18

Patient: 50 year old female

Reactions: Hypersensitivity, Influenza Like Illness

Drug(s) suspected as cause:
Prolastin



Possible Prolastin side effects in 60 year old male

Reported by a physician from Germany on 2012-04-18

Patient: 60 year old male

Reactions: Flushing, Chills

Drug(s) suspected as cause:
Prolastin



Possible Prolastin side effects in 66 year old female

Reported by a physician from United States on 2012-04-18

Patient: 66 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Drug Effect Decreased, Malaise, Unevaluable Event, Asthenia

Drug(s) suspected as cause:
Prolastin-C
    Dosage: 60 mg/kg;qw;iv
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2010-01-01

Prolastin
    Dosage: qm;iv
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2003-01-01



Possible Prolastin side effects in 47 year old male

Reported by a physician from Germany on 2012-04-18

Patient: 47 year old male

Reactions: Malaise, Chills, Influenza Like Illness

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Budiair; Berotec; Spiriva; Forair / 00958002 /



Possible Prolastin side effects in 51 year old male

Reported by a physician from Germany on 2012-04-18

Patient: 51 year old male

Reactions: Blood Pressure Systolic Increased, Drug Hypersensitivity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Albuterol; Symbicort



Possible Prolastin side effects in female

Reported by a physician from United States on 2012-04-18

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Prolastin



Possible Prolastin side effects in 59 year old male

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

Patient: 59 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Condition Aggravated, Alpha-1 Anti-Trypsin Deficiency

Drug(s) suspected as cause:
Prolastin



Possible Prolastin side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-11

Patient: 54 year old female

Reactions: Nasopharyngitis, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Oxycontin; Percocet; Albuterol



Possible Prolastin side effects in 45 year old female

Reported by a physician from Germany on 2012-02-24

Patient: 45 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Product Quality Issue, Heart Rate Decreased, Anaphylactic Shock

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Citalopram Hydrobromide; Theophylline; Fluticasone Propionate W / Salmeterol; Nasic; Fenoterol W / Ipratropium Bromide; Reactine DUO; Spiriva; Omeprazole; Dipyrone TAB; Acetaminophen



Possible Prolastin side effects in 45 year old female

Reported by a physician from Germany on 2012-02-06

Patient: 45 year old female

Reactions: Anaphylactic Shock, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prolastin

Other drugs received by patient: Fluticasone Propionate W / Salmeterol; Fenoterol W / Ipratropium Bromide; Spiriva; Theophylline; Citalopram Hydrobromide



Possible Prolastin side effects in 28 year old female

Reported by a individual with unspecified qualification from United Kingdom on 2011-10-12

Patient: 28 year old female

Reactions: Incorrect Drug Administration Rate, Dizziness, Coordination Abnormal, Dysphemia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Prolastin
    Dosage: 40 ml;qow;iv
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2005-01-01

Prolastin
    Dosage: 40 ml;qow;iv
    Indication: Panniculitis
    Start date: 2005-01-01

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