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Review Ifomide Safety Reports submitted to FDA

Total Ifomide reports: 19.
Ifomide FDA safety alerts: No.
Reported deaths: 8    Reported hospitalizations: 4.
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FDA Reported Ifomide Side Effects: encephalopathy, renal failure acute, pain in extremity, disease progression, fall, respiratory depression, renal impairment, loss of consciousness, hepatic function abnormal, cardio-respiratory arrest, cardiac arrest.
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Ifomide Side Effects Report #5648586-3
Consumer or non-health professional from UNITED STATES reported IFOMIDE problem on Feb 21, 2008. Male patient, 33 years of age, was diagnosed with prostate cancer, metastases to lung and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: cachexia, haemoglobin decreased, platelet count decreased, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CISPLATIN. Patient died on 12/20/2006.

Ifomide Side Effects Report #5610905-1
IFOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 23, 2008. Male patient, 45 years of age, was diagnosed with testicular neoplasm, prophylaxis and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, convulsion, fall, neutrophil count decreased, toxic encephalopathy, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with UROMITEXAN, TAXOL, RANDA, LASIX, MANNITOL, MEYLON, METOCLOPRAMIDE. Patient was hospitalized. Patient recovered.

Ifomide Side Effects Report #5579038-7
Consumer or non-health professional from UNITED STATES reported IFOMIDE problem on Dec 21, 2007. Male patient, 46 years of age, was diagnosed with testicular germ cell cancer and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, disseminated intravascular coagulation. IFOMIDE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CISPLATIN, CARBOPLATIN, PACLITAXEL, IRINOTECAN, NEDAPLATIN. Patient died on 12/18/2004.

Ifomide Side Effects Report #5581980-8
IFOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 28, 2007. Male patient, 46 years of age, was diagnosed with testicular neoplasm, prophylaxis and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, convulsion, fall, neutrophil count decreased, toxic encephalopathy, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with UROMITEXAN, TAXOL, RANDA, LASIX, MANNITOL, MEYLON, METOCLOPRAMIDE. Patient was hospitalized. Patient recovered.

Ifomide Side Effects Report #5583776-X
Consumer or non-health professional from JAPAN reported IFOMIDE problem on Dec 28, 2007. Female patient, 48 years of age, was diagnosed with extranodal nk/t-cell lymphoma, nasal type and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, haemoglobin decreased, nausea, osteonecrosis, platelet count decreased, stomatitis, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CARBOPLATIN, METHOTREXATE, PEPLOMYCIN SULPHATE, PREDONINE. Patient recovered.

Ifomide Side Effects Report #5587875-8
IFOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 08, 2008. Male patient, 46 years of age, was diagnosed with testicular neoplasm, prophylaxis and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, convulsion, fall, neutrophil count decreased, toxic encephalopathy, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with UROMITEXAN, TAXOL, RANDA, LASIX, MANNITOL, MEYLON, METOCLOPRAMIDE. Patient was hospitalized. Patient recovered.

Ifomide Side Effects Report #5599885-5
Consumer or non-health professional from UNITED STATES reported IFOMIDE problem on Jan 16, 2008. Male patient, 45 years of age, was diagnosed with testicular neoplasm, prophylaxis and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, convulsion, fall, neutrophil count decreased, toxic encephalopathy, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with UROMITEXAN, TAXOL, RANDA, LASIX, MANNITOL, MEYLON, METOCLOPRAMIDE. Patient was hospitalized. Patient recovered.

Ifomide Side Effects Report #5513930-4
IFOMIDE problem was reported by a Consumer or non-health professional from JAPAN on Nov 02, 2007. Female patient, 48 years of age, was diagnosed with extranodal nk/t-cell lymphoma, nasal type and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, haemoglobin decreased, nausea, osteonecrosis, platelet count decreased, stomatitis, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CARBOPLATIN, METHOTREXATE, PEPLOMYCIN SULPHATE, PREDONINE. Patient recovered.

Ifomide Side Effects Report #5519056-8
Consumer or non-health professional from JAPAN reported IFOMIDE problem on Nov 02, 2007. Female patient, 48 years of age, was diagnosed with extranodal nk/t-cell lymphoma, nasal type and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, haemoglobin decreased, nausea, osteonecrosis, platelet count decreased, stomatitis, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CARBOPLATIN, METHOTREXATE, PEPLOMYCIN SULPHATE, PREDONINE. Patient recovered.

Ifomide Side Effects Report #5519233-6
IFOMIDE problem was reported by a Consumer or non-health professional from JAPAN on Nov 02, 2007. Female patient, 48 years of age, was diagnosed with extranodal nk/t-cell lymphoma, nasal type and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, haemoglobin decreased, nausea, osteonecrosis, platelet count decreased, stomatitis, white blood cell count decreased. IFOMIDE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CARBOPLATIN, METHOTREXATE, PEPLOMYCIN SULPHATE, PREDONINE. Patient recovered.

Ifomide Side Effects Report #5479578-5
Physician from UNITED STATES reported IFOMIDE problem on Sept 24, 2007. Male patient, 17 years of age, was diagnosed with bone sarcoma, prophylaxis and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: encephalopathy. IFOMIDE dosage: unknown. During the same period patient was treated with CARBOPLATIN, LASTET, UROMITEXAN, MAGNESIUM SULPHATE, KYTRIL, MANNITOL, MEYLON. Patient recovered.

Ifomide Side Effects Report #5482216-9
IFOMIDE problem was reported by a Consumer or non-health professional from JAPAN on Sept 28, 2007. Male patient, 65 years of age, was diagnosed with prostate cancer, pain in extremity, transitional cell carcinoma and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: cyanosis, depressed level of consciousness, disease progression, haemoglobin decreased, neutrophil count decreased, pain in extremity, renal failure acute, respiratory failure. IFOMIDE dosage: unknown. During the same period patient was treated with TAXOL, AQUPLA, LOXONIN, METHOTREXATE, DOXORUBICIN, CISPLATIN, VINBLASTINE SULPHATE, CYTOTEC. Patient died on 10/07/2005.

Ifomide Side Effects Report #5441556-X
Consumer or non-health professional from JAPAN reported IFOMIDE problem on Aug 31, 2007. Male patient, 66 years of age, was diagnosed with prostate cancer, transitional cell carcinoma and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: disease progression, hypoaesthesia, pain in extremity, renal failure acute. IFOMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, DOXORUBICIN, TAXOL, CISPLATIN, VINBLASTINE SULPHATE, AQUPLA. Patient died.

Ifomide Side Effects Report #5448577-1
IFOMIDE problem was reported by a Physician from UNITED STATES on Sept 04, 2007. Male patient, 17 years of age, was diagnosed with bone sarcoma and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: encephalopathy. IFOMIDE dosage: unknown. During the same period patient was treated with CARBOPLATIN, LASTET. Patient recovered.

Ifomide Side Effects Report #5464234-X
Consumer or non-health professional from JAPAN reported IFOMIDE problem on Sept 14, 2007. Male patient, 65 years of age, was diagnosed with prostate cancer, pain in extremity, transitional cell carcinoma and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: cyanosis, depressed level of consciousness, disease progression, haemoglobin decreased, neutrophil count decreased, pain in extremity, renal failure acute, respiratory failure. IFOMIDE dosage: unknown. During the same period patient was treated with AQUPLA, LOXONIN, TAXOTERE, METHOTREXATE, DOXORUBICIN, TAXOL, CISPLATIN, VINBLASTINE SULPHATE. Patient died on 10/07/2005.

Ifomide Side Effects Report #5415621-7
IFOMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 10, 2007. Male patient, 66 years of age, was diagnosed with transitional cell carcinoma, pain in extremity and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: disease progression, pain in extremity, renal failure acute. IFOMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, DOXORUBICIN HYDROCHLORIDE, CISPLATIN, PACLITAXEL, VINBLASTINE SULPHATE, LOXONIN, AQUPLA, CYTOTEC. Patient recovered.

Ifomide Side Effects Report #5427244-4
Consumer or non-health professional from JAPAN reported IFOMIDE problem on Aug 24, 2007. Male patient, 66 years of age, was diagnosed with prostate cancer, transitional cell carcinoma, pain in extremity and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: disease progression, pain in extremity, renal failure acute. IFOMIDE dosage: unknown. During the same period patient was treated with METHOTREXATE, DOXORUBICIN, CISPLATIN, VINBLASTINE SULPHATE, LOXONIN, AQUPLA, TAXOL, CYTOTEC. Patient died.

Ifomide Side Effects Report #5379170-7
IFOMIDE problem was reported by a Physician from UNITED STATES on June 26, 2007. Male patient, 50 years of age, was diagnosed with testicular cancer metastatic and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, bone marrow failure, pneumonia. IFOMIDE dosage: unknown. During the same period patient was treated with AQUPLA, BLEOMYCIN, ETOPOSIDE, CISPLATIN, PACLITAXEL, IRINOTECAN, CARBENIN, EXACIN. Patient died on 05/19/2007.

Ifomide Side Effects Report #5379170-7
Physician from UNITED STATES reported IFOMIDE problem on June 26, 2007. Male patient, 50 years of age, was diagnosed with testicular cancer metastatic and was treated with IFOMIDE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, bone marrow failure, pneumonia. IFOMIDE dosage: unknown. During the same period patient was treated with AQUPLA, BLEOMYCIN, ETOPOSIDE, CISPLATIN, PACLITAXEL, IRINOTECAN, CARBENIN, EXACIN. Patient died on 05/19/2007.


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cachexia, haemoglobin decreased, platelet count decreased, white blood cell count decreased, confusional state, convulsion, fall, neutrophil count decreased, toxic encephalopathy, white blood cell count decreased, , was diagnosed with prostate cancer, metastases to lung and was diagnosed with testicular neoplasm, prophylaxis and