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Vesanoid (Tretinoin Oral) - Death - Suspected Cause - Side Effect Reports

 
 



Index of reports > Death (20)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vesanoid (Tretinoin Oral) death. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Vesanoid side effects in male

Reported by a physician from Japan on 2012-08-09

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Retinoic Acid Syndrome, Pulmonary Congestion, Acute Promyelocytic Leukaemia

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vesanoid
    Administration route: Oral
    Indication: Myelodysplastic Syndrome
    Start date: 2008-10-09
    End date: 2008-10-11

Vesanoid
    Administration route: Oral
    Start date: 2008-10-14
    End date: 2008-11-10

Other drugs received by patient: Cytarabine; Fragmin; Heparin Calcium; Maxipime; Idamycin; Itraconazole



Possible Vesanoid side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-31

Patient:

Reactions: Cardiac Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Vesanoid
    Indication: Acute Promyelocytic Leukaemia

Daunorubicin HCL
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: continous infusion for 7 days
    Indication: Acute Promyelocytic Leukaemia



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-19

Patient:

Reactions: Pulmonary Haemorrhage, Hyperglycaemia, Haematotoxicity

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Indication: Acute Myeloid Leukaemia

Vesanoid
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia

Cladribine
    Indication: Acute Myeloid Leukaemia



Possible Vesanoid side effects in 60 year old male

Reported by a pharmacist from Spain on 2012-06-14

Patient: 60 year old male

Reactions: Haemorrhagic Cerebral Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Vfend; Konakion; Polaramine; Ondansetron; Omeprazole; Meropenem; Ipratropium Bromide; Actocortina



Possible Vesanoid side effects in 62 year old male

Reported by a individual with unspecified qualification from Spain on 2012-06-13

Patient: 62 year old male

Reactions: Retinoic Acid Syndrome, Acute Respiratory Distress Syndrome, Leukocytosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in female

Reported by a physician from Japan on 2012-05-03

Patient: female, weighing 43.0 kg (94.6 pounds)

Reactions: Interstitial Lung Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2003-01-07
    End date: 2003-01-18

Vesanoid
    Administration route: Oral
    Start date: 2003-01-26
    End date: 2003-01-28

Other drugs received by patient: Mercaptopurine; Prednisolone Sodium Succinate; Idarubicin Hydrochloride; Sunrabin; Idarubicin Hydrochloride; Idarubicin Hydrochloride; Idarubicin Hydrochloride



Possible Vesanoid side effects in male

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

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Interstitial Lung Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Idarubicin Hydrochloride; Idarubicin Hydrochloride; Mercaptopurine; Idarubicin Hydrochloride; Idarubicin Hydrochloride; Prednisolone; Enocitabine



Possible Vesanoid side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-22

Patient:

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Guillain-Barre Syndrome, Haemorrhage, Pyrexia, Death, Renal Failure, Benign Intracranial Hypertension, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: high risk: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Idarubicin Hydrochloride
    Dosage: consolidation therapy: course 3: on day 1

Idarubicin Hydrochloride
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: high risk: course 3: days 1-5

Etoposide
    Dosage: consolidation: high risk: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Vesanoid
    Dosage: consolidation therapy
    Administration route: Oral

Mitoxantrone Hydrochloride
    Dosage: consolidation: high and low/intermediate risk: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Thioguanine
    Dosage: consolidation: high risk: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Idarubicin Hydrochloride
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Other drugs received by patient: Prednisone TAB



Possible Vesanoid side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-18

Patient:

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Haemorrhage, Pyrexia, Death, Retinoic Acid Syndrome, Renal Failure, Benign Intracranial Hypertension, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: course 3: days 1-5

Idarubicin HCL
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: consolidation therapy: course 3: on day 1

Mitoxantrone Hydrochloride
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Thioguanine
    Dosage: consolidation: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Prednisone



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from Italy on 2012-03-18

Patient:

Reactions: Guillain-Barre Syndrome, Acute Promyelocytic Leukaemia Differentiation Syndrome, Haemorrhage, Pyrexia, Death, Benign Intracranial Hypertension, Renal Failure, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: consolidation: high risk: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: high risk: course 3: days 1-5

Vesanoid
    Dosage: consolidation therapy
    Administration route: Oral

Thioguanine
    Dosage: consolidation: high risk: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Idarubicin HCL
    Dosage: consolidation therapy: course 3: on day 1

Etoposide
    Dosage: consolidation: high risk: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Mitoxantrone Hydrochloride
    Dosage: consolidation: high and low/intermediate risk: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Prednisone



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from Italy on 2012-03-13

Patient:

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Haemorrhage, Pyrexia, Death, Retinoic Acid Syndrome, Benign Intracranial Hypertension, Renal Failure, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Idarubicin HCL
    Dosage: consolidation therapy: course 3: on day 1

Cytarabine
    Dosage: consolidation: course 3: days 1-5

Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Mitoxantrone Hydrochloride
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Idarubicin HCL
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Etoposide
    Dosage: consolidation: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Thioguanine
    Dosage: consolidation: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Prednisone



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from United States on 2012-03-08

Patient:

Reactions: Retinoic Acid Syndrome, Myelodysplastic Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in

Reported by a individual with unspecified qualification from Italy on 2012-03-02

Patient:

Reactions: Guillain-Barre Syndrome, Acute Promyelocytic Leukaemia Differentiation Syndrome, Haemorrhage, Pyrexia, Death, Benign Intracranial Hypertension, Renal Failure, Embolism, Neutropenia, Myocardial Infarction, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid
    Dosage: consolidation therapy
    Administration route: Oral

Idarubicin Hydrochloride
    Dosage: consolidation therapy: course 3: on day 1

Idarubicin Hydrochloride
    Dosage: induction therapy: on days 2, 4, 6 and 8.
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: high risk: course 3: days 1-5

Idarubicin Hydrochloride
    Dosage: consolidation course 1: on days 1, 2, 3 and 4

Mitoxantrone Hydrochloride
    Dosage: consolidation: high and low/intermediate risk: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Thioguanine
    Dosage: consolidation: high risk: course 3: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Vesanoid
    Dosage: induction: until complete remission or for maximum 45 days.
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: consolidation: high risk: course 1: days 1-4.
    Indication: Acute Promyelocytic Leukaemia

Etoposide
    Dosage: consolidation: high risk: course 2: days 1-5
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Prednisone TAB



Possible Vesanoid side effects in 79 year old male

Reported by a individual with unspecified qualification from Japan on 2012-02-27

Patient: 79 year old male

Reactions: Interstitial Lung Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Prednisolone Sodium Succinate INJ; Idarubicin Hydrochloride; Enocitabine; Mercaptopurine



Possible Vesanoid side effects in 74 year old female

Reported by a physician from Japan on 2012-02-23

Patient: 74 year old female

Reactions: Interstitial Lung Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Enocitabine; Mercaptopurine; Idarubicin Hydrochloride; Prednisolone Sodium Succinate INJ



Possible Vesanoid side effects in male

Reported by a physician from Spain on 2011-12-27

Patient: male

Reactions: Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in male

Reported by a physician from Spain on 2011-12-23

Patient: male

Reactions: Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in 33 year old female

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

Patient: 33 year old female

Reactions: Multi-Organ Failure, Enterobacter Infection, Metabolic Acidosis, Hepatotoxicity, Gastrointestinal Toxicity, Septic Shock, Respiratory Distress

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vesanoid
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Dexamethasone Tablets Usp, 1.5 MG
    Indication: Acute Promyelocytic Leukaemia

Posaconazole
    Indication: Antifungal Prophylaxis

Amphotericin B
    Indication: Gastrointestinal Toxicity

Fluconazole

Idarubicin HCL
    Indication: Acute Promyelocytic Leukaemia



Possible Vesanoid side effects in male

Reported by a physician from Spain on 2011-12-20

Patient: male

Reactions: Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid



Possible Vesanoid side effects in 62 year old male

Reported by a physician from Japan on 2011-10-14

Patient: 62 year old male

Reactions: Pulmonary Haemorrhage, Retinoic Acid Syndrome, Disseminated Intravascular Coagulation, Gastric Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Vesanoid

Other drugs received by patient: Daunorubicin HCL; Cytarabine

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