Fludara and thrombotic microangiopathy Patient Reports February 10, 2010

Fludara Side Effects Report #6125632-4
Fludara side effect was reported by a Physician from JAPAN on Mar 12, 2009. Male patient, 44 years of age, weighting 147.7 lb, was diagnosed with stem cell transplant and was treated with Fludara. After drug was administered, patient experienced the following side effects: bacterial sepsis, pneumonia , thrombotic microangiopathy, viral haemorrhagic cystitis. Fludara dosage: TOTAL DAILY DOSE: 50 MG UNIT DOSE: 50 MG. During the same period patient was treated with BUSULFAN, CYTARABINE, ZETBULIN, TACROLIMUS HYDRATE, CYCLOSPORINE. Patient died on 09/27/2008.

Fludara Side Effects Report #6054890-X
Fludara side effect was reported by a Health Professional from JAPAN on Jan 22, 2009. Female patient, 42 years of age, was diagnosed with myelodysplastic syndrome, stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara. After drug was administered, patient experienced the following side effects: septic shock, thrombotic microangiopathy. Fludara dosage: AS USED: 180 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, MYCOPHENOLATE MOFETIL. Patient died.

Fludara Side Effects Report #6101150-4
Fludara side effect was reported by a Health Professional from JAPAN on Feb 26, 2009. Female patient, 42 years of age, weighting 116.8 lb, was diagnosed with myelodysplastic syndrome, stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara. After drug was administered, patient experienced the following side effects: graft versus host disease, sepsis , thrombotic microangiopathy. Fludara dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, MYCOPHENOLATE MOFETIL. Patient died on 04/12/2008.

Fludara Side Effects Report #6119100-3
Fludara side effect was reported by a Health Professional from JAPAN on Mar 10, 2009. Female patient, 42 years of age, weighting 116.8 lb, was diagnosed with myelodysplastic syndrome, stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara. After drug was administered, patient experienced the following side effects: graft versus host disease, sepsis , thrombotic microangiopathy. Fludara dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, MYCOPHENOLATE MOFETIL. Patient died on 04/12/2008.


Fludara Side Effects Report #6129293-X
Fludara side effect was reported by a Physician from JAPAN on Mar 18, 2009. Female patient, 59 years of age, weighting 94.80 lb, was treated with Fludara. After drug was administered, patient experienced the following side effects: acute graft versus host disease in intestine, acute graft versus host disease in liver, acute graft versus host disease in skin, thrombotic microangiopathy. Fludara dosage: TOTAL DAILY DOSE: 50 MG UNIT DOSE: 50 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, MYCOPHENOLATE MOFETIL. Patient died on 10/03/2008.

Fludara Side Effects Report #4620016-X
Fludara side effect was reported by a Physician from on Mar 11, 2005. Female patient, 52 years of age, was treated with Fludara. After drug was administered, patient experienced the following side effects: angiopathy, engraftment syndrome, haemorrhagic cerebral infarction, loss of consciousness, renal disorder, restlessness, thrombotic microangiopathy. Fludara dosage: 30 MG/M2, 1X/DAY, INTRAVENOUS. During the same period patient was treated with MELPHALAN, MYCOPHENOLATE MOFETIL. Patient died.

Fludara Side Effects Report #4639230-2
Fludara side effect was reported by a Physician from on Apr 05, 2005. Female patient, 52 years of age, was treated with Fludara. After drug was administered, patient experienced the following side effects: endothelial dysfunction, engraftment syndrome, haemorrhagic cerebral infarction, loss of consciousness, renal disorder, restlessness, thrombotic microangiopathy. Fludara dosage: 30 MG/M2, 1X/DAY, INTRAVENOUS. During the same period patient was treated with MELPHALAN, MYCOPHENOLATE MOFETIL. Patient died.

Fludara Side Effects Report #5495030-5
Fludara side effect was reported by a Physician from JAPAN on Oct 10, 2007. Female patient, 46 years of age, was diagnosed with lupus nephritis, prophylaxis and was treated with Fludara. After drug was administered, patient experienced the following side effects: thrombotic microangiopathy. Fludara dosage: unknown. During the same period patient was treated with CYCLOSPORINE, CAMPATH, CYCLOPHOSPHAMIDE. Patient recovered.

Fludara Side Effects Report #5550959-4
Fludara side effect was reported by a Physician from JAPAN on Nov 29, 2007. Female patient, 46 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Fludara. After drug was administered, patient experienced the following side effects: proteinuria, thrombotic microangiopathy. Fludara dosage: TOTAL DAILY DOSE: 28 MG. During the same period patient was treated with ALEMTUZUMAB, CYCLOPHOSPHAMIDE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.


Fludara Side Effects Report #5557368-2
Fludara side effect was reported by a Physician from JAPAN on Nov 29, 2007. Female patient, 46 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Fludara. After drug was administered, patient experienced the following side effects: proteinuria, thrombotic microangiopathy. Fludara dosage: TOTAL DAILY DOSE: 28 MG. During the same period patient was treated with ALEMTUZUMAB, CYCLOPHOSPHAMIDE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Fludara Side Effects Report #5495040-8
Fludara side effect was reported by a Physician from JAPAN on Oct 10, 2007. Female patient, 40 years of age, was diagnosed with prophylaxis and was treated with Fludara. After drug was administered, patient experienced the following side effects: convulsion, graft versus host disease, histiocytosis haematophagic, liver disorder, sepsis , thrombotic microangiopathy. Fludara dosage: unknown. During the same period patient was treated with MELPHALAN, TACROLIMUS. Patient died.

Fludara Side Effects Report #5542456-7
Fludara side effect was reported by a Physician from JAPAN on Dec 06, 2007. Female patient, 40 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Fludara. After drug was administered, patient experienced the following side effects: acute graft versus host disease, convulsion, histiocytosis haematophagic, liver disorder, sepsis , thrombotic microangiopathy. Fludara dosage: unknown. During the same period patient was treated with MELPHALAN, TACROLIMUS. Patient died on 11/14/2006.