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Paraplatin (Carboplatin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Paraplatin (Carboplatin) 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 (3)
Life Threatening Events (3)
Disability (1)

Reports by Reaction Type

Interstitial Lung Disease (7)Off Label Use (6)Gastrointestinal Perforation (4)Bone Sarcoma (3)Abdominal Pain Lower (2)Acute Myeloid Leukaemia (2)Glioma (1)Gastrointestinal Necrosis (1)Acute Monocytic Leukaemia (1)Disease Progression (1)Chest Pain (1)Malignant Melanoma (1)

Possible Paraplatin side effects in 56 year old male

Reported by a physician from France on 2012-08-22

Patient: 56 year old male

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: total dose:456mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-02-04
    End date: 2005-03-24

Gemzar
    Dosage: formulation-gemzar 1000 mg powder for sol for inf total dose:11.826mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-02-04
    End date: 2005-04-01

Paraplatin
    Dosage: formulation-paraplatine powder for sol for inj total dose:1.064mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-06-13
    End date: 2005-07-04

Paxene
    Dosage: paxene 6mg/ml solution for inf total dose:746mg
    Indication: Lung Adenocarcinoma
    Start date: 2005-06-13
    End date: 2005-07-04

Other drugs received by patient: Foradil; Fluticasone Propionate / Salmeterol; Acetaminophen



Possible Paraplatin side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Off Label Use, Acute Promyelocytic Leukaemia

Drug(s) suspected as cause:
Etoposide
    Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
    Indication: Retinoblastoma

Paraplatin
    Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
    Indication: Retinoblastoma

Vincristine
    Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
    Indication: Retinoblastoma



Possible Paraplatin side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Off Label Use, Bone Sarcoma

Drug(s) suspected as cause:
Etoposide
    Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
    Indication: Retinoblastoma

Paraplatin
    Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
    Indication: Retinoblastoma

Vincristine
    Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
    Indication: Retinoblastoma



Possible Paraplatin side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Off Label Use, Malignant Melanoma, Rhabdomyosarcoma

Drug(s) suspected as cause:
Etoposide
    Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
    Indication: Retinoblastoma

Paraplatin
    Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
    Indication: Retinoblastoma

Vincristine
    Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
    Indication: Retinoblastoma



Possible Paraplatin side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Off Label Use, Glioma

Drug(s) suspected as cause:
Etoposide
    Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
    Indication: Retinoblastoma

Paraplatin
    Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
    Indication: Retinoblastoma

Vincristine
    Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
    Indication: Retinoblastoma



Possible Paraplatin side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Off Label Use, Bone Sarcoma

Drug(s) suspected as cause:
Etoposide
    Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
    Indication: Retinoblastoma

Paraplatin
    Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
    Indication: Retinoblastoma

Vincristine
    Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
    Indication: Retinoblastoma



Possible Paraplatin side effects in

Reported by a physician from United States on 2012-08-08

Patient:

Reactions: Off Label Use, Bone Sarcoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Etoposide
    Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
    Indication: Retinoblastoma

Paraplatin
    Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
    Indication: Retinoblastoma

Vincristine
    Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
    Indication: Retinoblastoma



Possible Paraplatin side effects in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 49 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Soft Tissue Infection, Dyspnoea, Chest Pain, Anaemia, Platelet Count Decreased, Muscular Weakness, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cetuximab
    Dosage: 30jan12-12mar12 43 days,26mar12-unk
    Indication: Head and Neck Cancer
    Start date: 2012-01-30

Paraplatin
    Dosage: 30jan12-12mar12 43 days,26mar12-unk 3.75 auc
    Indication: Head and Neck Cancer
    Start date: 2012-01-30

Pemetrexed Disodium
    Dosage: 30jan12-12mar12 500mg/m2,26mar12-unk 375mg/m2
    Indication: Head and Neck Cancer
    Start date: 2012-01-30

Other drugs received by patient: Vitamin B-12; Folic Acid; Panthenol; Ensure; Fluticasone Propionate; Miralax; Ventolin



Possible Paraplatin side effects in 71 year old female

Reported by a consumer/non-health professional from Japan on 2012-06-26

Patient: 71 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Acute Monocytic Leukaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: twice every 3 weeks x 4 courses
    Indication: Breast Cancer
    Start date: 2010-09-22
    End date: 2010-11-25

Epirubicin
    Dosage: twice every 3 weeks x 4 courses
    Indication: Breast Cancer
    Start date: 2010-09-22
    End date: 2010-11-25

Fluorouracil
    Dosage: twice every 3 weeks x 4 courses
    Indication: Breast Cancer
    Start date: 2010-09-22
    End date: 2010-11-25

Paclitaxel
    Dosage: weekly x 12 courses
    Indication: Breast Cancer
    Start date: 2010-06-30
    End date: 2010-09-15

Paraplatin
    Dosage: auc 5 every 3 weeks x 4 courses
    Indication: Breast Cancer
    Start date: 2010-06-30
    End date: 2010-09-15



Possible Paraplatin side effects in 71 year old male

Reported by a consumer/non-health professional from Japan on 2012-03-01

Patient: 71 year old male

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paraplatin
    Indication: Lung Squamous Cell Carcinoma Stage Unspecified
    Start date: 2012-02-16
    End date: 2012-02-16

TS-1
    Administration route: Oral
    Start date: 2012-02-16
    End date: 2012-02-18



Possible Paraplatin side effects in 76 year old male

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

Patient: 76 year old male

Reactions: Lung Disorder, Neoplasm Malignant, Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paraplatin
    Indication: Lung Squamous Cell Carcinoma Stage Unspecified
    Start date: 2011-08-31
    End date: 2011-12-01

TS-1
    Administration route: Oral
    Indication: Lung Squamous Cell Carcinoma Stage Unspecified
    Start date: 2011-08-31
    End date: 2012-01-18



Possible Paraplatin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-20

Patient: male, weighing 59.7 kg (131.2 pounds)

Reactions: Disease Progression

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Avastin
    Indication: non-Small Cell Lung Cancer
    Start date: 2007-02-21
    End date: 2007-06-06

Avastin
    Start date: 2007-07-13
    End date: 2007-09-27

Gemzar
    Indication: non-Small Cell Lung Cancer
    Start date: 2007-09-27
    End date: 2007-09-27

Paraplatin
    Indication: non-Small Cell Lung Cancer
    Start date: 2007-02-07
    End date: 2007-08-23

Taxotere
    Indication: non-Small Cell Lung Cancer
    Start date: 2007-02-07
    End date: 2007-08-23

Other drugs received by patient: Duragesic-100; Duragesic-100; Morphine Sulfate; Duragesic-100; Morphine Sulfate; Duragesic-100; Ativan



Possible Paraplatin side effects in 72 year old female

Reported by a physician from Japan on 2012-01-16

Patient: 72 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Gastrointestinal Perforation, Abdominal Pain Lower

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Paraplatin
    Dosage: freq:other auc:6
    Indication: Ovarian Cancer
    Start date: 2011-08-30
    End date: 2011-09-27

Taxol
    Dosage: 180mg/m2:224 mg on 30aug11 stopped on 27sep11 freq:other.
    Indication: Ovarian Cancer



Possible Paraplatin side effects in 78 year old male

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

Patient: 78 year old male

Reactions: Duodenal Perforation

Drug(s) suspected as cause:
Paraplatin



Possible Paraplatin side effects in 72 year old female

Reported by a consumer/non-health professional from Japan on 2012-01-02

Patient: 72 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Abdominal Pain Lower, Gastrointestinal Perforation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Paraplatin
    Dosage: freq:other auc:6
    Indication: Ovarian Cancer
    Start date: 2011-08-30
    End date: 2011-09-27

Taxol
    Dosage: 180mg/m2:224 mg on 30aug11 stopped on 27sep11 freq:other.
    Indication: Ovarian Cancer



Possible Paraplatin side effects in

Reported by a consumer/non-health professional from Japan on 2011-12-23

Patient:

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Paraplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Paraplatin side effects in

Reported by a consumer/non-health professional from Japan on 2011-12-23

Patient:

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Paraplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Paraplatin side effects in

Reported by a consumer/non-health professional from Japan on 2011-12-23

Patient:

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Paraplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Paraplatin side effects in

Reported by a consumer/non-health professional from Japan on 2011-12-23

Patient:

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Paraplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Paraplatin side effects in

Reported by a consumer/non-health professional from Japan on 2011-12-23

Patient:

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Paraplatin
    Indication: non-Small Cell Lung Cancer

Taxol
    Indication: non-Small Cell Lung Cancer



Possible Paraplatin side effects in 71 year old female

Reported by a physician from Japan on 2011-11-24

Patient: 71 year old female

Reactions: Gastrointestinal Necrosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Paraplatin
    Indication: Fallopian Tube Cancer
    Start date: 2011-10-18

Taxol
    Indication: Fallopian Tube Cancer
    Start date: 2011-10-18



Possible Paraplatin side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-21

Patient: female

Reactions: Acute Myeloid Leukaemia

Drug(s) suspected as cause:
Gefitinib
    Indication: Lung Adenocarcinoma
    Start date: 2008-07-01

Paclitaxel
    Indication: Lung Adenocarcinoma

Paraplatin
    Indication: Lung Adenocarcinoma

Tegafur + Uracil
    Indication: Lung Adenocarcinoma

Vinorelbine
    Indication: Lung Adenocarcinoma



Possible Paraplatin side effects in 68 year old female

Reported by a consumer/non-health professional from Japan on 2011-11-16

Patient: 68 year old female

Reactions: Renal Impairment, Skin Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paraplatin
    Indication: Ovarian Cancer
    Start date: 2011-11-04
    End date: 2011-11-04

Taxol
    Dosage: route :div
    Indication: Ovarian Cancer
    Start date: 2011-11-04
    End date: 2011-11-04



Possible Paraplatin side effects in 72 year old female

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

Patient: 72 year old female

Reactions: Gastrointestinal Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paraplatin
    Indication: Ovarian Cancer

Taxol
    Indication: Ovarian Cancer



Possible Paraplatin side effects in 72 year old female

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

Patient: 72 year old female

Reactions: Gastrointestinal Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Paraplatin
    Indication: Ovarian Cancer

Taxol
    Indication: Ovarian Cancer



Possible Paraplatin side effects in 68 year old male

Reported by a physician from Japan on 2011-10-07

Patient: 68 year old male, weighing 57.5 kg (126.5 pounds)

Reactions: Encephalitis Viral

Drug(s) suspected as cause:
Cyclosporine
    Dosage: 350 mg/m2 x 1/4 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-04-25
    End date: 2011-07-05

Cytarabine
    Dosage: 40 mg x 1/8 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-31

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2 x 1/4week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-04-25
    End date: 2011-07-05

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2 x 1/4week
    Start date: 2011-05-02
    End date: 2011-07-12

Etoposide
    Dosage: 100 mg/m2 x 1/4 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-09
    End date: 2011-07-28

Fildesin
    Dosage: 2.4 mg/m2 x 1/4 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-09
    End date: 2011-07-28

KW-0761
    Dosage: 1.0 mg/kg x 1/2 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-04-26
    End date: 2011-07-27

Methotrexate Sodium
    Dosage: 15 mg x 1/8 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-31

Paraplatin
    Dosage: 250 mg/m2 x 1/4 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-09
    End date: 2011-07-28

Prednisolone
    Dosage: 40 mg/m2 x 1/4 week
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-04-25
    End date: 2011-07-05

Prednisolone
    Dosage: 40 mg/m2 x 1/4 week
    Administration route: Oral
    Start date: 2011-05-09
    End date: 2011-07-28

Prednisolone
    Dosage: 40 mg/m2 x 1/4 week
    Administration route: Oral
    Start date: 2011-05-02
    End date: 2011-07-12

Prednisolone
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Rash
    Start date: 2011-08-18

Prednisolone Sodium Succinate INJ
    Dosage: 10 mg x 1/8 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-31

Ranimustine
    Dosage: 60 mg/m2 x 1/4 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-05-02
    End date: 2011-07-12

Vincristine Sulfate
    Dosage: 1 mg/m2 x 1/4 week
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2011-04-25
    End date: 2011-07-05

Other drugs received by patient: Diflucan; Gluconsan K; Magmitt; Pursennid; Epinastine Hydrochloride; Myser; Targocid; Hicee; Aspirin; Ketoprofen; Adona; Omeprazole; Sulfamethoxazole; Maxipime; Lendormin; Posterisan; Slow-K

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