Busulfex and convulsion Patient Reports February 10, 2010

Busulfex Side Effects Report #5803072-2
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on June 23, 2008. Male patient, child 8 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, convulsion, diarrhoea, escherichia infection, febrile neutropenia, graft versus host disease, liver function test abnormal, malaise, stomatitis. Busulfex dosage: 10 ML, INTRAVENOUS. During the same period patient was treated with ANTILYMPHOCYTE IMMUNOGLOBULIN, FLUDARABINE PHOSPHATE, VALPROATE, MIDAZOLAM. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5877536-X
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Aug 26, 2008. Male patient, child 8 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anorexia, convulsion, diarrhoea, escherichia infection, febrile convulsion, febrile neutropenia, hepatic function abnormal, malaise. Busulfex dosage: 10 ML, INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE, VALPROATE, MIDAZOLAM, ANTITHYMOCYTE IMMUNOGLOBULIN, CYCLOSPORINE, METHYLPREDNISOLONE, LENOGRASTIM. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5819440-9
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on July 08, 2008. Male patient, 67 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, chest discomfort, constipation , convulsion, diarrhoea, encephalitis , erythema, malaise, oedema. Busulfex dosage: 30 ML, INTRAVENOUS. During the same period patient was treated with MELPHALAN, TACROLIMUS. Patient died on 03/11/2007.

Busulfex Side Effects Report #5886252-X
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Sept 01, 2008. Male patient, 67 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, chest discomfort, constipation , convulsion, diarrhoea, encephalitis viral, erythema, malaise, oedema. Busulfex dosage: 30 ML INTRAVENOUS. During the same period patient was treated with MELPHALAN, TACROLIMUS. Patient died.


Busulfex Side Effects Report #5878608-6
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Aug 25, 2008. Male patient, 65 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: convulsion, diarrhoea, encephalitis viral, pneumonia , stem cell transplant, stomatitis. Busulfex dosage: 36.68 ML, DAILY DOSE INTRAVENOUS. During the same period patient was treated with MELPHALAN, TACROLIMUS. Patient died.

Busulfex Side Effects Report #5857246-5
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on July 30, 2008. Female patient, 64 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease in skin, acute respiratory distress syndrome, anorexia, blood bilirubin increased, bone marrow transplant rejection, bronchoalveolar lavage abnormal, candidiasis, convulsion, diarrhoea. Busulfex dosage: 5 ML, INTRAVENOUS;10 ML, INTRAVENOUS; 20 ML, INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, NARTOGRASTIM, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient died.

Busulfex Side Effects Report #5888931-7
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Sept 03, 2008. Female patient, 64 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, acute respiratory distress syndrome, anorexia, blood bilirubin increased, bone marrow transplant rejection, candida pneumonia, convulsion, diarrhoea, disseminated intravascular coagulation. Busulfex dosage: 5 ML, DAILY DOSE INTRAVENOUS; 10 ML, DAILY DOSE; INTRAVENOUS. During the same period patient was treated with FOSCARNET, FLUDARABINE PHOSPHATE, VALPROATE, NARTOGRASTIM, LENOGRASTIM, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient died on 10/14/2007.

Busulfex Side Effects Report #6076409-X
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Jan 28, 2009. Male patient, 62 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: convulsion. Busulfex dosage: 0.8 MG/KG INTRAVENOUS. During the same period patient was treated with FLUDRABINE PHOSPHATE, LYMPHOBLOBULINE, PHENYTOIN, DEPAKENE. Patient recovered.

Busulfex Side Effects Report #6072884-5
Busulfex side effect was reported by a Physician from JAPAN on Jan 21, 2009. Male patient, 58 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: blood pressure increased, convulsion, encephalitis herpes, headache , pyrexia, reversible posterior leukoencephalopathy syndrome. Busulfex dosage: unknown. Patient recovered.


Busulfex Side Effects Report #5888695-7
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on July 30, 2008. Female patient, 55 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anorexia, arthritis bacterial, bone marrow transplant rejection, cardiac failure, chronic graft versus host disease, convulsion, cytomegalovirus viraemia. Busulfex dosage: 10.6 ML. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, FILGRASTIM, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5819583-X
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on July 07, 2008. Male patient, 52 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, blood lactate dehydrogenase increased, bone marrow transplant , catheter sepsis, convulsion, cystitis haemorrhagic, diarrhoea. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, FLIGRASTIM, METHOTREXATE, TACROLIMUS, MYOPHENOLATE MOFETIL, MICAFUNGIN, GANCICLOVIR. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #6072908-5
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Jan 22, 2009. Male patient, 51 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: blood bilirubin increased, bone marrow transplant , cardiac arrest , convulsion, graft versus host disease, melaena, no therapeutic response, toxic encephalopathy. Busulfex dosage: 200 MG, DAILY DOSE INTRAVENOUS. During the same period patient was treated with TACROLIMUS, VALPROATE, CYCLOPHOSPHAMIDE, FILGRASTIM, METHOTREXATE, CYCLOSPORINE. Patient died.

Busulfex Side Effects Report #5818264-6
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on July 07, 2008. Female patient, child 5 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, convulsion, diarrhoea, graft versus host disease, grand mal convulsion. Busulfex dosage: 11.2 ML, DAILY DOSE. During the same period patient was treated with CYCLOPHOSPHAMIDE, PHENYTOIN, FILGRASTIM, CYCLOSPORINE, METHYLPREDNISOLONE. Patient recovered.

Busulfex Side Effects Report #5822823-4
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on July 14, 2008. Male patient, 46 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia recurrent, anorexia, convulsion, diarrhoea, graft versus host disease, malaise, nausea , staphylococcal sepsis, stomatitis. Busulfex dosage: 27 ML, INTRAVENOUS, 36 ML DAILY DOSE; INTRAVENOUS, 9 ML, DAILY DOSE; INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, LENOGRASTIM, TACROLIMUS, CYTARABINE. Patient was hospitalized. Patient died on 08/29/2007.


Busulfex Side Effects Report #5921368-0
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Oct 01, 2008. Male patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, bone marrow transplant rejection, convulsion, cystitis haemorrhagic, venoocclusive liver disease. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOSPORINE, FILGRASTIM, METHOTREXATE. Patient recovered.

Busulfex Side Effects Report #5928793-2
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Oct 10, 2008. Male patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, bone marrow transplant rejection, convulsion, cystitis haemorrhagic, venoocclusive liver disease. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOSPORINE, FILGRASTIM, METHOTREXATE. Patient recovered.

Busulfex Side Effects Report #5974410-5
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Nov 18, 2008. Male patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, blood creatinine increased, bone marrow transplant rejection, cellulitis , cerebral haemorrhage, convulsion, cystitis haemorrhagic, depressed level of consciousness, histiocytosis haematophagic. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOSPORINE, FILGRASTIM, METHOTREXATE. Patient died on 11/10/2007.

Busulfex Side Effects Report #6030744-X
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Dec 25, 2008. Male patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anorexia, bone marrow transplant rejection, cellulitis , cerebral haemorrhage, convulsion, cystitis haemorrhagic, cytomegalovirus viraemia, depressed level of consciousness. Busulfex dosage: 45 MG, QID INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOSPORINE, FILGRASTIM, METHOTREXATE. Patient died on 11/10/2007.

Busulfex Side Effects Report #6065359-0
Busulfex side effect was reported by a Consumer or non-health professional from GERMANY on Jan 19, 2009. Male patient, child 3 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: convulsion, hyponatraemia, inappropriate antidiuretic hormone secretion. Busulfex dosage: 18.6 MG, QID, INTRAVENOUS. During the same period patient was treated with ACYCLOVIR, METRONIDAZOLE, ONDANSETRON, LORAZEPAM, CEFTRIAXONE, TOBRAMYCIN SULPHATE. Patient recovered.


Busulfex Side Effects Report #5729837-3
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Apr 21, 2008. Male patient, 25 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia recurrent, altered state of consciousness, anorexia, bone marrow failure, cardiac arrest , cellulitis , convulsion, diarrhoea, engraft failure. Busulfex dosage: 30 ML INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized and became disabled. Patient died.

Busulfex Side Effects Report #5803069-2
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on June 23, 2008. Female patient was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute lymphocytic leukaemia recurrent, anorexia, convulsion, diarrhoea, graft versus host disease, nausea , respiratory disorder, stomatitis, venoocclusive liver disease. Busulfex dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, CLONAZEPAM, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfex Side Effects Report #5862338-0
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Aug 12, 2008. Female patient was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, convulsion, diarrhoea, encephalitis viral, graft versus host disease, human herpesvirus 6 infection, malaise, sepsis , stomatitis. Busulfex dosage: 6 ML 46.8 ML, DAILY DOSE; INTRAVENOUS 4.2 ML, DAILY DOSE; INTRAVENOUS. During the same period patient was treated with MELPHALAN, PHENYTOIN, FILGRASTIM, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfex Side Effects Report #4786884-6
Busulfex side effect was reported by a Pharmacist from UNITED STATES on Sept 16, 2005. Male patient, 36 years of age, was diagnosed with multiple myeloma  and was treated with Busulfex. After drug was administered, patient experienced the following side effects: convulsion, morphoea. Busulfex dosage: unknown. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5729831-2
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Apr 22, 2008. Male patient, 23 years of age, was treated with Busulfex. After drug was administered, patient experienced the following side effects: bone marrow transplant rejection, convulsion, cytokine storm, diarrhoea, encephalitis viral, engraftment syndrome, graft versus host disease, liver disorder, malaise. Busulfex dosage: 9.4 ML, QID; INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE, VALPROATE, NARTOGRASTIM, METHOTREXATE, TACROLIMUS. Patient was hospitalized. Patient died.