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Bicnu (Carmustine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Bicnu (Carmustine) 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 (26)
Death (6)
Life Threatening Events (6)

Reports by Reaction Type

Incorrect Storage of Drug (6)Acute Pulmonary Oedema (4)Streptococcal Bacteraemia (3)Myelodysplastic Syndrome (3)Erythema (3)Dyspnoea (3)Acute Myeloid Leukaemia (3)Lymphopenia (3)Ejection Fraction Decreased (3)Necrotising Fasciitis (3)Gastrointestinal Haemorrhage (2)Cardiac Failure Acute (2)

Possible Bicnu side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09

Patient: 60 year old female

Reactions: Myelofibrosis, Acute Myeloid Leukaemia, Myelodysplastic Syndrome, Idiopathic Thrombocytopenic Purpura

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Vepesid
    Dosage: intravenous (not otherwise sepcified)
    Indication: Multiple Myeloma

Dexamethasone
    Dosage: 4 years, intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Vincristine Sulfate
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Bicnu
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Velcade
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma
    Start date: 2008-05-05

Velcade
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma
    Start date: 2008-05-19

Velcade
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma
    Start date: 2008-04-08

Alkeran
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Cyclophosphamide
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Doxorubicin Hydrochloride
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Prednisone
    Dosage: intravenous (not otherwise specified)
    Indication: Multiple Myeloma

Other drugs received by patient: Neupogen; Corticosteroids



Possible Bicnu side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01

Patient: female

Reactions: Acute Myeloid Leukaemia, Myelodysplastic Syndrome

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Velcade
    Indication: Multiple Myeloma
    Start date: 2008-04-08
    End date: 2008-09-01

Dexamethasone
    Start date: 2008-04-08

Bicnu
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Doxorubicin Hydrochloride
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Cyclophosphamide
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Dexamethasone
    Start date: 2008-06-01
    End date: 2008-01-01

Prednisone
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Vincristine
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Alkeran
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Dexamethasone
    Indication: Multiple Myeloma
    Start date: 2008-05-05

Dexamethasone
    Start date: 2008-05-19

Vepesid
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01



Possible Bicnu side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01

Patient: female

Reactions: Acute Myeloid Leukaemia, Myelodysplastic Syndrome

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Bicnu
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Alkeran
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Dexamethasone
    Indication: Multiple Myeloma
    Start date: 2004-01-01
    End date: 2008-01-01

Cyclophosphamide
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Vepesid
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Dexamethasone
    Start date: 2008-04-08
    End date: 2008-09-01

Prednisone
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Vincristine
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01

Velcade
    Indication: Multiple Myeloma
    Start date: 2008-04-08
    End date: 2008-06-01

Doxorubicin Hydrochloride
    Indication: Multiple Myeloma
    Start date: 2000-01-01
    End date: 2000-01-01



Possible Bicnu side effects in 45 year old female

Reported by a consumer/non-health professional from Latvia on 2012-07-17

Patient: 45 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: Dyspnoea, Nausea, Dizziness, Erythema, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicnu

Other drugs received by patient: Ifosfamide; Doxorubicin HCL; Etoposide



Possible Bicnu side effects in 45 year old female

Reported by a consumer/non-health professional from Latvia on 2012-07-06

Patient: 45 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: Dyspnoea, Nausea, Dizziness, Asthenia, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicnu

Other drugs received by patient: Doxorubicin HCL; Etoposide; Ifosfamide



Possible Bicnu side effects in 58 year old male

Reported by a consumer/non-health professional from Latvia on 2012-07-06

Patient: 58 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Throat Irritation, Erythema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Bicnu

Other drugs received by patient: Doxorubicin HCL; Ifosfamide; Etoposide



Possible Bicnu side effects in 56 year old male

Reported by a consumer/non-health professional from France on 2012-06-06

Patient: 56 year old male

Reactions: Acute Pulmonary Oedema, Cardiac Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Mabthera
    Dosage: maintenance treatment at the dose of 375 mg/m2 every 3 weeks from 09-jan-2012
    Start date: 2011-02-10

Bicnu
    Start date: 2011-06-08

Etoposide
    Start date: 2011-06-09
    End date: 2011-06-12

Alkeran
    Start date: 2011-06-13

Cytarabine
    Start date: 2011-06-09
    End date: 2011-06-12

Other drugs received by patient: Nexium; Bactrim; Rocephin; Targocid; Valacyclovir Hydrochloride; Leucovorin Calcium; Cisplatin



Possible Bicnu side effects in

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Bicnu



Possible Bicnu side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-26

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Bicnu

Etopophos Preservative Free

Erbitux



Possible Bicnu side effects in

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Bicnu



Possible Bicnu side effects in

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Bicnu

Erbitux

Blenoxane



Possible Bicnu side effects in

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Bicnu



Possible Bicnu side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-26

Patient:

Reactions: Incorrect Storage of Drug

Drug(s) suspected as cause:
Bicnu



Possible Bicnu side effects in

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Bicnu



Possible Bicnu side effects in

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Bicnu



Possible Bicnu side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-12

Patient: female

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etoposide
    Start date: 2011-06-17
    End date: 2011-06-20

Cytarabine
    Start date: 2011-06-17
    End date: 2011-06-20

Alkeran
    Start date: 2011-06-21
    End date: 2011-06-21

Bicnu
    Start date: 2011-06-17
    End date: 2011-06-17

Other drugs received by patient: Metformin HCL; Valacyclovir Hydrochloride; Imovane; Tramadol HCL; Bicarbonat; Diamicron



Possible Bicnu side effects in 57 year old female

Reported by a physician from France on 2012-01-06

Patient: 57 year old female

Reactions: Confusional State, Acute Pulmonary Oedema, Hallucination, Visual, Cardiac Failure, Ejection Fraction Decreased, Aspergillosis, Tricuspid Valve Incompetence

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Etoposide
    Dosage: 202 mg/m2
    Indication: Lymphoma
    Start date: 2011-11-17
    End date: 2011-11-20

Mabthera
    Dosage: 500 mg/m2,14jul2011:1scourse:14jul,2nd course:09aug,3rd course:08sep,4th course:06oct.15nov2011
    Indication: Lymphoma
    Start date: 2011-07-14

Alkeran
    Dosage: 139 mg/m2
    Indication: Lymphoma
    Start date: 2011-11-21

Cytarabine
    Dosage: 398 mg/m2,1s cours:12jul2011,2nd cours:11aug2011,3rd course:10sep2011,4th cours:06oct2011,17nov2011
    Indication: Lymphoma
    Start date: 2011-07-12
    End date: 2011-11-20

Bicnu
    Dosage: 297 mg/m2
    Indication: Lymphoma
    Start date: 2011-11-16

Other drugs received by patient: Fluconazole; Nexium; Amikacin; Oxacillin Sodium; Gentamicin; Zovirax; Vancomycin; Rocephin; Bactrim; Tienam; Ciprofloxacin



Possible Bicnu side effects in 63 year old female

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

Patient: 63 year old female

Reactions: Multi-Organ Failure, Intestinal Obstruction, Altered State of Consciousness

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: cytarabine sandoz
    Indication: Lymphoma
    Start date: 2011-07-15
    End date: 2011-07-18

Alkeran
    Indication: Lymphoma
    Start date: 2011-07-19

Bicnu
    Indication: Lymphoma
    Start date: 2011-07-15

Etoposide
    Indication: Lymphoma
    Start date: 2011-07-15
    End date: 2011-07-18



Possible Bicnu side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-27

Patient: male

Reactions: Vomiting, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etoposide
    Indication: non-Hodgkin's Lymphoma
    Start date: 2011-07-15
    End date: 2011-07-18

Alkeran
    Indication: non-Hodgkin's Lymphoma
    Start date: 2011-07-19
    End date: 2011-07-19

Cytarabine
    Indication: non-Hodgkin's Lymphoma
    Start date: 2011-07-15
    End date: 2011-07-18

Bicnu
    Indication: non-Hodgkin's Lymphoma
    Start date: 2011-07-15
    End date: 2011-07-18

Other drugs received by patient: Fungizone; Piperacillin and Tazobactam; Fortzaar (Losartan - Hydrochlorothiazide); Tarka; Nexium; Zovirax; Xanax; Oxycodone HCL; Acetaminophen; Caspofungine



Possible Bicnu side effects in male

Reported by a physician from France on 2011-12-22

Patient: male

Reactions: Streptococcal Bacteraemia, Lymphopenia, Necrotising Fasciitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Bicnu
    Dosage: 1inj three times per week
    Start date: 2011-07-04
    End date: 2011-07-13

Diprosone
    Dosage: 1app per day
    Administration route: Topical
    End date: 2011-07-13

Clobetasol Propionate
    Dosage: 1app see dosage text
    Administration route: Topical
    End date: 2011-07-12

Methotrexate
    Dosage: 20mg weekly
    Start date: 2011-07-04
    End date: 2011-07-11



Possible Bicnu side effects in 62 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-19

Patient: 62 year old female

Reactions: Acute Pulmonary Oedema, Ejection Fraction Decreased, Febrile Bone Marrow Aplasia, Cardiac Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Etoposide
    Dosage: 172 mg, 2x/day
    Start date: 2011-01-08
    End date: 2011-01-11

Bicnu
    Dosage: 516 mg, one single dose
    Start date: 2011-01-07
    End date: 2011-01-07

Cytarabine
    Dosage: 172 mg/day
    Start date: 2011-01-08
    End date: 2011-01-11

Doxorubicin HCL
    Dosage: 8 cycles
    Start date: 2009-05-01
    End date: 2009-10-01

Alkeran
    Dosage: 240 mg, one single dose
    Start date: 2011-01-12
    End date: 2011-01-12

Other drugs received by patient: Clonazepam; Nexium; Neulasta; Neorecormon; Valacyclovir Hydrochloride; Fluconazole



Possible Bicnu side effects in 82 year old male

Reported by a physician from France on 2011-12-19

Patient: 82 year old male

Reactions: Blood Creatine Phosphokinase Increased, Streptococcal Bacteraemia, Lymphopenia, Myoglobin Blood Increased, Necrotising Fasciitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Methotrexate Sodium
    Dosage: 20 mg, qw, parn
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-04
    End date: 2011-07-11

Bicnu
    Dosage: 1 df, tiw, top
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-04
    End date: 2011-07-13

Diprosone
    Dosage: 1 df, qd, top
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    End date: 2011-07-13

Clobetasol Propionate
    Dosage: 1 df, top
    Administration route: Topical
    Indication: Product Used FOR Unknown Indication
    End date: 2011-07-12



Possible Bicnu side effects in 62 year old female

Reported by a consumer/non-health professional from France on 2011-12-19

Patient: 62 year old female

Reactions: Acute Pulmonary Oedema, Gastrointestinal Haemorrhage, General Physical Health Deterioration, Cardiac Failure Acute, Drug Rash With Eosinophilia and Systemic Symptoms, Death, Multi-Organ Failure, Renal Impairment, Ejection Fraction Decreased, Pleural Effusion

Adverse event resulted in: death

Drug(s) suspected as cause:
Melphalan Hydrochloride
    Dosage: in one take
    Start date: 2011-01-12

Bicnu
    Dosage: in one take
    Start date: 2011-01-07

Etoposide
    Dosage: also 2*172mg
    Start date: 2011-01-08
    End date: 2011-01-11

Doxorubicin HCL
    Start date: 2009-05-01
    End date: 2009-10-01

Cytarabine
    Dosage: also 2*172mg
    Start date: 2011-01-08
    End date: 2011-01-11

Other drugs received by patient: Clonazepam; Neulasta; Flagyl; Fluconazole; Nexium; Piperacillin and Tazobactam; Flagyl; Tobramycin; Tienam; Neorecormon; Vancomycin; Augmentin; Valacyclovir Hydrochloride; Ciprofloxacin



Possible Bicnu side effects in 82 year old male

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

Patient: 82 year old male

Reactions: Streptococcal Bacteraemia, Lymphopenia, Necrotising Fasciitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Bicnu
    Dosage: 1df=0.4286 dose units nos
    Administration route: Topical
    Indication: Mycosis Fungoides
    Start date: 2011-07-04
    End date: 2011-07-13

Diprosone
    Dosage: diprosone 0.025% cream
    Administration route: Topical
    End date: 2011-07-13

Clobetasol Propionate
    Dosage: dermoval 0.05% cream, 1df=0.5714 units nos
    Administration route: Topical
    End date: 2011-07-12

Methotrexate Sodium
    Dosage: inj 2.8571mg
    Indication: Mycosis Fungoides
    Start date: 2011-07-04
    End date: 2011-07-11

Other drugs received by patient: Corticosteroid



Possible Bicnu side effects in female

Reported by a physician from France on 2011-12-05

Patient: female

Reactions: Anaemia, Coagulopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bicnu
    Dosage: unknown
    Indication: Mycosis Fungoides
    Start date: 2011-03-01
    End date: 2011-06-01

Targretin
    Dosage: unknown
    Administration route: Oral
    Indication: Mycosis Fungoides
    Start date: 2011-01-01
    End date: 2011-01-01

Other drugs received by patient: Fluticasone Propionate; Tiotropium; Clopidogrel; Folic Acid; Albuterol Sulfate Autohaler; FER; Betamethasone Cream; Dexeryl; Almitrine; Atorvastatin; Levothyroxine Sodium; Lyrica; Zolpidem; Trimeprazine TAB; Gluconate DE Zinc; Acetaminophen



Possible Bicnu side effects in male

Reported by a physician from France on 2011-10-24

Patient: male

Reactions: Tongue Oedema, Dysaesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oncovin
    Indication: Medulloblastoma
    Start date: 2011-10-04
    End date: 2011-10-04

Bicnu
    Indication: Medulloblastoma
    Start date: 2011-10-04
    End date: 2011-10-04

Zofran
    Indication: Premedication
    Start date: 2011-10-04
    End date: 2011-10-04

Emend
    Administration route: Oral
    Indication: Premedication
    Start date: 2011-10-03
    End date: 2011-10-03

Plitican
    Indication: Premedication
    Start date: 2011-10-03
    End date: 2011-10-03

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