Busulfan and thrombotic microangiopathy Patient Reports February 12, 2012

Busulfan Side Effects Report #5269623-4
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Mar 08, 2007. Male patient, 54 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: cystitis haemorrhagic, graft versus host disease, thrombotic microangiopathy, venoocclusive liver disease, weight increased. Busulfan dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, VALPROATE. Patient died on 12/19/2006.

Busulfan Side Effects Report #5299878-1
Busulfan side effect was reported by a Health Professional from JAPAN on Mar 27, 2007. Male patient, 54 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: cystitis haemorrhagic, diarrhoea, graft versus host disease, hepatic function abnormal, pyrexia, thrombotic microangiopathy, venoocclusive liver disease. Busulfan dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, VALPROATE. Patient died on 12/19/2006.

Busulfan Side Effects Report #5586032-9
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Female patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: altered state of consciousness, febrile neutropenia, grand mal convulsion, pruritus, stomatitis, thrombotic microangiopathy, venoocclusive liver disease. Busulfan dosage: 26.68 ML; IV. Patient recovered.

Busulfan Side Effects Report #5385508-7
Busulfan side effect was reported by a Health Professional from JAPAN on June 26, 2007. Male patient, 31 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, blood bilirubin increased, blood lactate dehydrogenase increased, cystitis haemorrhagic, thrombotic microangiopathy, viraemia. Busulfan dosage: unknown. Patient was hospitalized. Patient recovered.


Busulfan Side Effects Report #5468657-4
Busulfan side effect was reported by a Health Professional from JAPAN on Sept 11, 2007. Female patient, 30 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: febrile neutropenia, haptoglobin decreased, platelet count decreased, red blood cell schistocytes present, thrombotic microangiopathy. Busulfan dosage: 26.12 ML;QD;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, VALPROATE, NEUPOGEN, METHOTREXATE, CICLOSPORIN. Patient died.

Busulfan Side Effects Report #5466154-3
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Sept 10, 2007. Male patient, 20 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: altered state of consciousness, diarrhoea, gastrointestinal perforation, stress ulcer, thrombotic microangiopathy, upper gastrointestinal haemorrhage. Busulfan dosage: 31.2 ML;QD;IV; 41.6 ML;QD;IV; 10.4 ML;QD;IV. During the same period patient was treated with NEUPOGEN, VALPROATE, CYCLOPHOSPHAMIDE, METHOTREXATE, TACROLIMUS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5585745-2
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 20 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: altered state of consciousness, diarrhoea, gastrointestinal perforation, stress ulcer, thrombotic microangiopathy, upper gastrointestinal haemorrhage. Busulfan dosage: 31.2 ML; QD; IV, 41.6 ML; QD; IV, 10.4 ML; QD; IV. During the same period patient was treated with FILGRASTIM, VALPROATE, CYCLOPHOSPHAMIDE, METHOTREXATE, TACROLIMUS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #4627429-0
Busulfan side effect was reported by a Physician from on Mar 16, 2005. Female patient, 19 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: graft versus host disease, thrombotic microangiopathy. Busulfan dosage: 4 MG/KG IV. Patient recovered.

Busulfan Side Effects Report #4627430-7
Busulfan side effect was reported by a Physician from on Mar 16, 2005. Female patient, 18 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: disease recurrence, graft versus host disease, pneumocystis jiroveci pneumonia, pneumothorax, thrombotic microangiopathy. Busulfan dosage: 4 MG/KG IV. Patient recovered.


Busulfan Side Effects Report #5570087-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 03, 2007. Male patient, 17 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: blood pressure decreased, hepatic failure, metabolic acidosis, staphylococcal sepsis, stomatitis, thrombotic microangiopathy, venoocclusive disease. Busulfan dosage: 172 MG;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPAHATE. Patient died on 09/13/2007.

Busulfan Side Effects Report #5523818-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Nov 05, 2007. Female patient, child 1 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: obliterative bronchiolitis, respiratory failure, thrombotic microangiopathy. Busulfan dosage: 2.8 ML; QD; IV, 4.0 ML; QD; IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, CLONAEPAM, METHOTREXATE, TARCOLIMUS, CYCLOSPORINE. Patient died on 06/25/2007.