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Cosmegen (Dactinomycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cosmegen (Dactinomycin) 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 (13)
Death (3)

Reports by Reaction Type

Ototoxicity (4)Breast Cancer in Situ (2)Death (2)Agitation (1)Infection (1)Tachycardia (1)Neoplasm Progression (1)Osteomyelitis (1)Liver Disorder (1)Rickets (1)Nephroblastoma (1)Chest Discomfort (1)

Possible Cosmegen side effects in 24 month old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: 24 month old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cosmegen
    Dosage: 1.5 mg/m2 milligram(s)/sq.meter, 1 in 1 d
    Indication: Chemotherapy

Doxorubicin HCL
    Dosage: 37.5 m/m2 milligram(s)/sq.1 in 1 d
    Indication: Chemotherapy

Cisplatin
    Dosage: 75 mg/m2 milligram(s)/sq. meter, 1 in 1 d
    Indication: Chemotherapy

Other drugs received by patient: Ifosfamide; Etoposide; Cyclophosphamide; Therapeutic Radiopharmaceuticals (Therapeutic Radiopharmaceuticals); Vincristine



Possible Cosmegen side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-12

Patient: male

Reactions: Fanconi Syndrome, Rickets, Myopathy

Drug(s) suspected as cause:
Etoposide
    Dosage: 1 df dosage

Carboplatin
    Dosage: 2.275 g gram(s), intravenous (not otherwise specified)

Vincristine Sulfate

Adriamycin PFS

Cyclophosphamide
    Dosage: , intravenous (not otherwise specified)

Cosmegen
    Dosage: , intravenous (not otherwise specified)

Other drugs received by patient: Ifosfamide(ifosfamide)(powder FOR Solution FOR Injection)



Possible Cosmegen side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06

Patient:

Reactions: Ototoxicity

Drug(s) suspected as cause:
Methotrexate Sodium
    Dosage: 300 mg/m2 milligram (s) /sq.meter, day 8
    Indication: Gestational Trophoblastic Tumour

Etoposide
    Dosage: 150;100 mg/m2 sq.meter, day 1;8
    Indication: Gestational Trophoblastic Tumour

Cosmegen
    Dosage: 0.5 mg, day, intravenous, day 8,
    Indication: Gestational Trophoblastic Tumour

Cisplatin
    Dosage: 75 mg/m2 milligram (s)/sq.meter, day 1, intravenous infusion
    Indication: Gestational Trophoblastic Tumour



Possible Cosmegen side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-06

Patient:

Reactions: Ototoxicity

Drug(s) suspected as cause:
Cisplatin
    Dosage: 75 mg/m2 milligram(s) / sq. meter, day 1, intravenous (not otherwise specified)
    Indication: Gestational Trophoblastic Tumour

Etoposide
    Dosage: 150 mg/m2 milligram(s) /sq. meter, day 1; 100 mg/m2 milligram(s) / sq. meter, day 8
    Indication: Gestational Trophoblastic Tumour

Methotrexate Sodium
    Dosage: 300 mg/m2 milligram(s) / sq. meter, day 8
    Indication: Gestational Trophoblastic Tumour

Cosmegen
    Dosage: 0.5 mg milligram(s), day 8, intravenous (not otherwise specified)
    Indication: Gestational Trophoblastic Tumour



Possible Cosmegen side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-06

Patient:

Reactions: Gestational Trophoblastic Tumour, Neoplasm Progression, Ototoxicity

Drug(s) suspected as cause:
Cisplatin
    Dosage: 75 mg/m2 milligram(s) / sq. meter, day 1, intravenous (not otherwise specified)
    Indication: Gestational Trophoblastic Tumour

Etoposide
    Dosage: 150 mg/m2 milligram(s) / sq. meter, day 1; 100 mg/m2 milligram(s) / sq. meter, day 8
    Indication: Gestational Trophoblastic Tumour

Methotrexate Sodium
    Dosage: 300 mg/m2 milligram(s) / sq. meter, day 8
    Indication: Gestational Trophoblastic Tumour

Cosmegen
    Dosage: 0.5 mg milligram(s), day 8, intravenous (not otherwise specified)
    Indication: Gestational Trophoblastic Tumour



Possible Cosmegen side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06

Patient:

Reactions: Ototoxicity

Drug(s) suspected as cause:
Cosmegen
    Dosage: 0.5 mg milligram(s), day 8, intravenous (not otherwise specified)
    Indication: Gestational Trophoblastic Tumour

Etoposide
    Dosage: 150 mg/m2 milligram(s) / sq. meter, day 1; 200 mg/m2 milligram(s) / sq. meter, day 8
    Indication: Gestational Trophoblastic Tumour

Cisplatin
    Dosage: 75 mg/m2 milligram(s) /sq. meter, day 1, intravenous (not otherwise specified)
    Indication: Gestational Trophoblastic Tumour

Methotrexate Sodium
    Dosage: 300 mg/m2 milligram(s) /sq. meter, day 8
    Indication: Gestational Trophoblastic Tumour



Possible Cosmegen side effects in 4 year old female

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

Patient: 4 year old female

Reactions: Osteomyelitis, Periostitis

Drug(s) suspected as cause:
Cosmegen



Possible Cosmegen side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-06

Patient: female, weighing 6.3 kg (13.9 pounds)

Reactions: Venoocclusive Liver Disease, Encephalopathy, Liver Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Cosmegen

Other drugs received by patient: Ciprofloxacin; Fluconazole; Ondansetron; Total Parenteral Nutrition (Nutrition Care Cartaq 10); Neolab Cotrimoxazole (Bactrim); Enoxaparin Sodium; Fentanyl; Vincristine; Cyclophosphamide; Granulocyte-Colony Stimulating (Granulocyte Colony Stimulating Factor); Meropenem



Possible Cosmegen side effects in 44 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-30

Patient: 44 year old male

Reactions: Cachexia, Infection

Drug(s) suspected as cause:
Vincristine
    Indication: Rhabdomyosarcoma

Cosmegen
    Indication: Rhabdomyosarcoma

Epirubicin
    Indication: Rhabdomyosarcoma

Etoposide
    Indication: Rhabdomyosarcoma

Carboplatin
    Indication: Rhabdomyosarcoma

Other drugs received by patient: Irradiation (Other Therapeutic Radiopharmaceuticals)



Possible Cosmegen side effects in 24 month old male

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

Patient: 24 month old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vincristine
    Dosage: 0.065 mg/kg milligram(s) / kilogram, frequency not reported

Cisplatin
    Dosage: 75 mg/m2 milligram(s) / sq. meter, frequency not reported

Cyclophosphamide
    Dosage: 65 mg/m2 milligram(s) / sq. meter, frequency not reported; 2200 mg/m2 milligram(s)/sq.meter, frequen

Doxorubicin HCL
    Dosage: 37.5 mg/m2 milligram(s) / sq. meter, frequency not reported

Cosmegen
    Dosage: 1.5 mg/m2 milligram(s) / sq. meter, frequency not reported

Etoposide
    Dosage: 100 mg/m2 milligram(s) /sq.meter, frequency not reported

Ifosfamide
    Dosage: 2.4 mg/m2 milligram(s) / sq. meter, frequency not reported

Therapeutic Radiopharmaceuticals (Therapeutic Radiopharmaceuticals)
    Dosage: frequency not reported



Possible Cosmegen side effects in 21 year old female

Reported by a physician from United States on 2011-10-13

Patient: 21 year old female

Reactions: Bone Marrow Transplant, Recurrent Cancer, Nephroblastoma, Breast Cancer in Situ

Drug(s) suspected as cause:
Doxorubicin HCL
    Indication: Nephroblastoma

Thiotepa
    Indication: Nephroblastoma

Cosmegen
    Indication: Nephroblastoma

Vincristine
    Indication: Nephroblastoma

Etoposide
    Indication: Nephroblastoma

Cyclophosphamide
    Indication: Nephroblastoma

Carboplatin
    Indication: Nephroblastoma



Possible Cosmegen side effects in 21 year old female

Reported by a physician from United States on 2011-10-12

Patient: 21 year old female

Reactions: Fibrocystic Breast Disease, Breast Cancer in Situ

Drug(s) suspected as cause:
Cosmegen
    Indication: Nephroblastoma

Carboplatin
    Indication: Nephroblastoma

Vincristine
    Indication: Nephroblastoma

Doxorubicin HCL
    Indication: Nephroblastoma

Cyclophosphamide
    Indication: Nephroblastoma

Etoposide
    Indication: Nephroblastoma

Thiotepa
    Indication: Nephroblastoma



Possible Cosmegen side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-11

Patient: 56 year old female

Reactions: Agitation, Back Pain, Hypersensitivity, Chest Discomfort, Nausea, Tachycardia, Anaphylactic Reaction, Rash Macular, Flushing, NO Therapeutic Response, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cosmegen
    Indication: Product Used FOR Unknown Indication

Etoposide
    Indication: Gestational Trophoblastic Tumour
    Start date: 2011-09-22

Etoposide
    Indication: Gestational Trophoblastic Tumour
    Start date: 2011-09-23

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