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Review Mylotarg Safety Reports submitted to FDA

Total Mylotarg reports: 160.
Mylotarg FDA safety alerts: No.
Reported deaths: 61    Reported hospitalizations: 105.
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FDA Reported Mylotarg Side Effects: febrile neutropenia, platelet count decreased, anaemia, neutrophil count decreased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, condition aggravated, sepsis, blood alkaline phosphatase increased, disseminated intravascular coagulation.
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Mylotarg Side Effects Report #5403081-1
Physician from JAPAN reported MYLOTARG problem on July 30, 2007. Male patient, weighting 119.0 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: pneumonia, venoocclusive liver disease. MYLOTARG dosage: unknown. During the same period patient was treated with FAMOTIDINE, DIFLUCAN, LEVOFLOXACIN, LASIX, SELBEX. Patient died on 03/27/2007.

Mylotarg Side Effects Report #5404200-3
MYLOTARG problem was reported by a Physician from JAPAN on July 25, 2007. Female patient, weighting 125.7 lb, was diagnosed with acute myeloid leukaemia recurrent, graft versus host disease, febrile neutropenia, pneumocystis jiroveci pneumonia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaphylactic shock, pneumonia staphylococcal. MYLOTARG dosage: unknown. During the same period patient was treated with URSO, MAXIPIME, BENAMBAX. Patient was hospitalized and became disabled. Patient recovered.

Mylotarg Side Effects Report #5404331-8
Physician from JAPAN reported MYLOTARG problem on July 26, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, anaemia, blast cell count increased, blood potassium increased, c-reactive protein increased, condition aggravated, disseminated intravascular coagulation, febrile neutropenia. MYLOTARG dosage: unknown. During the same period patient was treated with BAKTAR, DIFLUCAN, POLYMYXIN B SULPHATE, ZANTAC, MUCOSTA. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5408566-X
MYLOTARG problem was reported by a Physician from JAPAN on Aug 02, 2007. Female patient, weighting 136.7 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: neutrophil count decreased, pulmonary alveolar haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with FUNGUARD, PAZUCROSS. Patient was hospitalized. Patient died on 07/15/2007.

Mylotarg Side Effects Report #5410045-0
Physician from JAPAN reported MYLOTARG problem on Aug 01, 2007. Female patient, weighting 138.9 lb, was diagnosed with acute myeloid leukaemia recurrent, interstitial lung disease, gingivitis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, body temperature decreased, gingivitis, interstitial lung disease, liver disorder, pyrexia, toxic skin eruption. MYLOTARG dosage: unknown. During the same period patient was treated with PREDNISOLONE, AMINOACETIC ACID, DALACIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5411369-3
MYLOTARG problem was reported by a Physician from JAPAN on Aug 06, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood albumin decreased, c-reactive protein increased, febrile neutropenia, fibrin degradation products increased, nausea, neutrophil count decreased, platelet count decreased, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with PREDNISOLONE, RABEPRAZOLE, BAKTAR, CYTARABINE, DIFLUCAN, CIPROFLOXACIN, PURSENNID. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5419702-3
Physician from JAPAN reported MYLOTARG problem on Aug 10, 2007. Male patient, weighting 138.9 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: apnoeic attack, bacterial infection, disseminated intravascular coagulation, gastrointestinal haemorrhage, hypokalaemia, pancytopenia, pulmonary haemorrhage, tetany. MYLOTARG dosage: unknown. During the same period patient was treated with SUCRALFATE, POLYMYXIN B SULPHATE, BAKTAR, FUNGIZONE. Patient recovered.

Mylotarg Side Effects Report #5420780-6
MYLOTARG problem was reported by a Physician from JAPAN on Aug 17, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin conjugated increased, blood chloride decreased, blood creatinine increased, blood lactate dehydrogenase increased, blood potassium increased, blood sodium decreased. MYLOTARG dosage: unknown. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5422300-9
Physician from JAPAN reported MYLOTARG problem on Aug 10, 2007. Female patient, weighting 88.18 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, hyperuricaemia, neutropenia, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with LANSOPRAZOLE, ITRACONAZOLE, OXYCONTIN, PENTCILLIN, BAKTAR, ZOLPIDEM TARTRATE, FUNGUARD, LEVOFLOXACIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5426236-9
MYLOTARG problem was reported by a Physician from JAPAN on Aug 17, 2007. Male patient, weighting 141.1 lb, was diagnosed with acute myeloid leukaemia, pyrexia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, haematocrit decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, red blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with FLUTIDE DISKUS, MAXIPIME, BAKTAR, FLUCONAZOLE, AMLODIPINE, ALOSENN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5376161-7
Physician from JAPAN reported MYLOTARG problem on June 27, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin conjugated increased, blood chloride decreased, blood creatinine increased, blood lactate dehydrogenase increased, blood potassium increased, blood sodium decreased. MYLOTARG dosage: unknown. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5376303-3
MYLOTARG problem was reported by a Physician from JAPAN on June 21, 2007. Male patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, neutrophil count decreased, platelet count decreased, pneumonia, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with GLEEVEC, FLUCONAZOLE, ALTAT, BAKTAR, CIPROFLOXACIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5376736-5
Physician from JAPAN reported MYLOTARG problem on June 22, 2007. Male patient, weighting 92.59 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, benign prostatic hyperplasia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: confusional state. MYLOTARG dosage: unknown. During the same period patient was treated with FUNGUARD, CIPROFLOXACIN, DIOVAN, MARZULENE S, HARNAL, CERNILTON, URSO, MEROPENEM. Patient recovered.

Mylotarg Side Effects Report #5378974-4
MYLOTARG problem was reported by a Physician from JAPAN on June 25, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, infection and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anorexia, gingival bleeding, hepatic function abnormal, neutrophil count decreased, platelet count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with ITRACONAZOLE, FAMOTIDINE, CIPROFLOXACIN, FUNGUARD, BAKTAR, RISEDRONATE, DALTEPARIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5379015-5
Physician from JAPAN reported MYLOTARG problem on June 25, 2007. Female patient, weighting 77.16 lb, was diagnosed with acute myeloid leukaemia, pneumonia, neutrophil count decreased and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood urea increased, disease progression, liver disorder, neutrophil count decreased, pancytopenia, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with CIPROFLOXACIN, VANCOMYCIN, BIAPENEM, AMINOACETIC ACID. Patient was hospitalized. Patient died on 10/09/2006.

Mylotarg Side Effects Report #5382828-7
MYLOTARG problem was reported by a Physician from JAPAN on July 02, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, cellulitis, condition aggravated, diarrhoea, epistaxis, hepatic function abnormal, mucous membrane disorder, neutrophil count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, KYTRIL, SAXIZON, NOVANTRONE, ITRACONAZOLE, FAMOTIDINE. Patient was hospitalized. Patient died on 09/02/2006.

Mylotarg Side Effects Report #5383126-8
Physician from JAPAN reported MYLOTARG problem on July 04, 2007. Male patient, weighting 158.7 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, constipation, nasopharyngitis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cellulitis, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with MAXIPIME, TAKEPRON, ALUMINIUM HYDROXIDE, CIPROFLOXACIN, ANTIPYRINE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5383693-4
MYLOTARG problem was reported by a Physician from UNITED STATES on Sept 19, 2006. Female patient, 69 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. MYLOTARG dosage: 9 MG/M^2 1X PER 1 DAY, INTRAVENOUS. During the same period patient was treated with CIPRO. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5384163-X
Physician from JAPAN reported MYLOTARG problem on July 02, 2007. Male patient, weighting 121.3 lb, was diagnosed with acute myeloid leukaemia, constipation, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, gastrointestinal haemorrhage, haemorrhagic diathesis, hepatic function abnormal, renal failure, sepsis, septic shock, subdural haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, SELBEX, FUNGUARD, BAKTAR, FLUCONAZOLE, POLYMYXIN B SULPHATE. Patient was hospitalized. Patient died on 02/01/2007.

Mylotarg Side Effects Report #5384164-1
MYLOTARG problem was reported by a Physician from UNITED STATES on July 02, 2007. Female patient, weighting 158.3 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: torsade de pointes, ventricular fibrillation. MYLOTARG dosage: 11 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with CYTARABINE, COMPAZINE, DEXAMETHASONE, BENADRYL, MORPHINE, LORAZEPAM, LISINOPRIL, AMBIEN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5384235-X
Physician from JAPAN reported MYLOTARG problem on July 04, 2007. Female patient, weighting 85.98 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, febrile neutropenia, platelet count decreased, pleural effusion, weight increased. MYLOTARG dosage: unknown. During the same period patient was treated with VANCOMYCIN, ZYVOX, VFEND, BAKTAR, DALACIN, ITRACONAZOLE. Patient recovered.

Mylotarg Side Effects Report #5386496-X
MYLOTARG problem was reported by a Physician from JAPAN on July 05, 2007. Male patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, epilepsy, neutrophil count decreased, tonsillitis. MYLOTARG dosage: unknown. During the same period patient was treated with DIFLUCAN, ALEVIATIN, BAKTAR, MUCOSTA, LANSOPRAZOLE, HARNAL. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5387608-4
Consumer or non-health professional from UNITED STATES reported MYLOTARG problem on July 11, 2007. Male patient, weighting 150.1 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. MYLOTARG dosage: 5 MG. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5388504-9
MYLOTARG problem was reported by a Physician from JAPAN on July 09, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood albumin decreased, c-reactive protein increased, febrile neutropenia, fibrin degradation products increased, nausea, neutrophil count decreased, platelet count decreased, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with PREDNISOLONE, PARIET, ZEFFIX, DIFLUCAN, CIPROFLOXACIN, PURSENNID, FRAGMIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5388508-6
Physician from JAPAN reported MYLOTARG problem on July 09, 2007. Male patient, weighting 119.0 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acidosis, liver disorder, lymphocyte count decreased, neutrophil count decreased, sinus tachycardia, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with OMEGACIN, METHOTREXATE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5388949-7
MYLOTARG problem was reported by a Physician from JAPAN on July 06, 2007. Male patient, weighting 143.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, febrile neutropenia, hypertension, pulmonary mycosis. MYLOTARG dosage: unknown. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5389699-3
Physician from JAPAN reported MYLOTARG problem on July 10, 2007. Female patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, infection, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, c-reactive protein increased, febrile neutropenia, neutrophil count decreased, platelet count decreased, systemic mycosis, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BIFIDOBACTERIUM BIFIDUM, TOBRACIN, NITRAZEPAM, TIENAM, LANSOPRAZOLE, OLOPATADINE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5391478-8
MYLOTARG problem was reported by a Physician from JAPAN on July 11, 2007. Male patient, weighting 141.1 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, pyrexia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, haematocrit decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, red blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with FLUTIDE DISKUS, ALOSENN, FUNGUARD, FLUCONAZOLE, MAXIPIME, DORZOLAMIDE. Patient recovered.

Mylotarg Side Effects Report #5393337-3
Physician from UNITED STATES reported MYLOTARG problem on July 12, 2007. Male patient, 43 years of age, weighting 162.7 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disease progression, enterocolitis infectious, pancytopenia, pelvic infection, pericardial effusion, pleural effusion. MYLOTARG dosage: 11.5 MG TOTAL DOSE. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient was hospitalized. Patient died on 06/01/2007.

Mylotarg Side Effects Report #5395434-5
MYLOTARG problem was reported by a Physician from JAPAN on July 17, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, liver disorder, neutropenia, platelet count decreased, pneumocystis jiroveci pneumonia. MYLOTARG dosage: unknown. During the same period patient was treated with PREDONINE, SELBEX. Patient died on 06/24/2007.

Mylotarg Side Effects Report #5395435-7
Physician from JAPAN reported MYLOTARG problem on July 17, 2007. Male patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood urea increased, cerebral haemorrhage, condition aggravated, disseminated intravascular coagulation, febrile neutropenia, hypernatraemia, pneumonia, renal impairment. MYLOTARG dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, ROXATIDINE ACETATE, GLUCOSEECTION, DIFLUCAN, VITAMEDIN, SOLDEM, STRONG NEO MINOPHAGEN C. Patient was hospitalized. Patient died on 02/23/2007.

Mylotarg Side Effects Report #5396951-4
MYLOTARG problem was reported by a Physician from JAPAN on July 19, 2007. Female patient, 74 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: pulmonary alveolar haemorrhage. MYLOTARG dosage: unknown. Patient died on 07/15/2007.

Mylotarg Side Effects Report #5397497-X
Physician from JAPAN reported MYLOTARG problem on July 19, 2007. Female patient, weighting 101.4 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, febrile neutropenia, sepsis, venoocclusive liver disease. MYLOTARG dosage: unknown. Patient died on 06/01/2007.

Mylotarg Side Effects Report #5398106-6
MYLOTARG problem was reported by a Physician from UNITED STATES on July 18, 2007. Female patient, 39 years of age, weighting 127.0 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, alanine aminotransferase increased, alpha haemolytic streptococcal infection, aspartate aminotransferase increased, blood creatinine increased, blood culture positive, bradycardia, cardio-respiratory arrest, cerebral haemorrhage. MYLOTARG dosage: 9.7 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient was hospitalized. Patient died on 07/23/2007.

Mylotarg Side Effects Report #5398974-8
Consumer or non-health professional from UNITED STATES reported MYLOTARG problem on July 24, 2007. Female patient, weighting 152.6 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, pancreatitis. MYLOTARG dosage: 5 MG. During the same period patient was treated with CYTARABINE, DAUNORUBICIN, ETOPOSIDE, DEXAMETHASONE, PREDNISONE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5376161-7
MYLOTARG problem was reported by a Physician from JAPAN on June 27, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin conjugated increased, blood chloride decreased, blood creatinine increased, blood lactate dehydrogenase increased, blood potassium increased, blood sodium decreased. MYLOTARG dosage: unknown. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5376303-3
Physician from JAPAN reported MYLOTARG problem on June 21, 2007. Male patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, neutrophil count decreased, platelet count decreased, pneumonia, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with GLEEVEC, FLUCONAZOLE, ALTAT, BAKTAR, CIPROFLOXACIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5376736-5
MYLOTARG problem was reported by a Physician from JAPAN on June 22, 2007. Male patient, weighting 92.59 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, benign prostatic hyperplasia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: confusional state. MYLOTARG dosage: unknown. During the same period patient was treated with FUNGUARD, CIPROFLOXACIN, DIOVAN, MARZULENE S, HARNAL, CERNILTON, URSO, MEROPENEM. Patient recovered.

Mylotarg Side Effects Report #5378974-4
Physician from JAPAN reported MYLOTARG problem on June 25, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, infection and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anorexia, gingival bleeding, hepatic function abnormal, neutrophil count decreased, platelet count decreased, sepsis. MYLOTARG dosage: unknown. During the same period patient was treated with ITRACONAZOLE, FAMOTIDINE, CIPROFLOXACIN, FUNGUARD, BAKTAR, RISEDRONATE, DALTEPARIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5379015-5
MYLOTARG problem was reported by a Physician from JAPAN on June 25, 2007. Female patient, weighting 77.16 lb, was diagnosed with acute myeloid leukaemia, pneumonia, neutrophil count decreased and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood urea increased, disease progression, liver disorder, neutrophil count decreased, pancytopenia, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with CIPROFLOXACIN, VANCOMYCIN, BIAPENEM, AMINOACETIC ACID. Patient was hospitalized. Patient died on 10/09/2006.

Mylotarg Side Effects Report #5382828-7
Physician from JAPAN reported MYLOTARG problem on July 02, 2007. Male patient, weighting 130.1 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, cellulitis, condition aggravated, diarrhoea, epistaxis, hepatic function abnormal, mucous membrane disorder, neutrophil count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with CYTARABINE, KYTRIL, SAXIZON, NOVANTRONE, ITRACONAZOLE, FAMOTIDINE. Patient was hospitalized. Patient died on 09/02/2006.

Mylotarg Side Effects Report #5383126-8
MYLOTARG problem was reported by a Physician from JAPAN on July 04, 2007. Male patient, weighting 158.7 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, constipation, nasopharyngitis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cellulitis, neutrophil count decreased, platelet count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with MAXIPIME, TAKEPRON, ALUMINIUM HYDROXIDE, CIPROFLOXACIN, ANTIPYRINE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5383693-4
Physician from UNITED STATES reported MYLOTARG problem on Sept 19, 2006. Female patient, 69 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. MYLOTARG dosage: 9 MG/M^2 1X PER 1 DAY, INTRAVENOUS. During the same period patient was treated with CIPRO. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5384163-X
MYLOTARG problem was reported by a Physician from JAPAN on July 02, 2007. Male patient, weighting 121.3 lb, was diagnosed with acute myeloid leukaemia, constipation, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, gastrointestinal haemorrhage, haemorrhagic diathesis, hepatic function abnormal, renal failure, sepsis, septic shock, subdural haemorrhage. MYLOTARG dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, SELBEX, FUNGUARD, BAKTAR, FLUCONAZOLE, POLYMYXIN B SULPHATE. Patient was hospitalized. Patient died on 02/01/2007.

Mylotarg Side Effects Report #5384164-1
Physician from UNITED STATES reported MYLOTARG problem on July 02, 2007. Female patient, weighting 158.3 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: torsade de pointes, ventricular fibrillation. MYLOTARG dosage: 11 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with CYTARABINE, COMPAZINE, DEXAMETHASONE, BENADRYL, MORPHINE, LORAZEPAM, LISINOPRIL, AMBIEN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5384235-X
MYLOTARG problem was reported by a Physician from JAPAN on July 04, 2007. Female patient, weighting 85.98 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, febrile neutropenia, platelet count decreased, pleural effusion, weight increased. MYLOTARG dosage: unknown. During the same period patient was treated with VANCOMYCIN, ZYVOX, VFEND, BAKTAR, DALACIN, ITRACONAZOLE. Patient recovered.

Mylotarg Side Effects Report #5386496-X
Physician from JAPAN reported MYLOTARG problem on July 05, 2007. Male patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, epilepsy, neutrophil count decreased, tonsillitis. MYLOTARG dosage: unknown. During the same period patient was treated with DIFLUCAN, ALEVIATIN, BAKTAR, MUCOSTA, LANSOPRAZOLE, HARNAL. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5387608-4
MYLOTARG problem was reported by a Consumer or non-health professional from UNITED STATES on July 11, 2007. Male patient, weighting 150.1 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. MYLOTARG dosage: 5 MG. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5388504-9
Physician from JAPAN reported MYLOTARG problem on July 09, 2007. Male patient, weighting 116.8 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, blood albumin decreased, c-reactive protein increased, febrile neutropenia, fibrin degradation products increased, nausea, neutrophil count decreased, platelet count decreased, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with PREDNISOLONE, PARIET, ZEFFIX, DIFLUCAN, CIPROFLOXACIN, PURSENNID, FRAGMIN. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5388508-6
MYLOTARG problem was reported by a Physician from JAPAN on July 09, 2007. Male patient, weighting 119.0 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acidosis, liver disorder, lymphocyte count decreased, neutrophil count decreased, sinus tachycardia, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with OMEGACIN, METHOTREXATE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5388949-7
Physician from JAPAN reported MYLOTARG problem on July 06, 2007. Male patient, weighting 143.3 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, febrile neutropenia, hypertension, pulmonary mycosis. MYLOTARG dosage: unknown. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5389699-3
MYLOTARG problem was reported by a Physician from JAPAN on July 10, 2007. Female patient, weighting 123.5 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis, infection, insomnia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: anaemia, c-reactive protein increased, febrile neutropenia, neutrophil count decreased, platelet count decreased, systemic mycosis, white blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with BIFIDOBACTERIUM BIFIDUM, TOBRACIN, NITRAZEPAM, TIENAM, LANSOPRAZOLE, OLOPATADINE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Mylotarg Side Effects Report #5391478-8
Physician from JAPAN reported MYLOTARG problem on July 11, 2007. Male patient, weighting 141.1 lb, was diagnosed with acute myeloid leukaemia, prophylaxis, pyrexia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, haematocrit decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, red blood cell count decreased. MYLOTARG dosage: unknown. During the same period patient was treated with FLUTIDE DISKUS, ALOSENN, FUNGUARD, FLUCONAZOLE, MAXIPIME, DORZOLAMIDE. Patient recovered.

Mylotarg Side Effects Report #5393337-3
MYLOTARG problem was reported by a Physician from UNITED STATES on July 12, 2007. Male patient, 43 years of age, weighting 162.7 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: disease progression, enterocolitis infectious, pancytopenia, pelvic infection, pericardial effusion, pleural effusion. MYLOTARG dosage: 11.5 MG TOTAL DOSE. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient was hospitalized. Patient died on 06/01/2007.

Mylotarg Side Effects Report #5395434-5
Physician from JAPAN reported MYLOTARG problem on July 17, 2007. Male patient, weighting 149.9 lb, was diagnosed with acute myeloid leukaemia recurrent, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: condition aggravated, liver disorder, neutropenia, platelet count decreased, pneumocystis jiroveci pneumonia. MYLOTARG dosage: unknown. During the same period patient was treated with PREDONINE, SELBEX. Patient died on 06/24/2007.

Mylotarg Side Effects Report #5395435-7
MYLOTARG problem was reported by a Physician from JAPAN on July 17, 2007. Male patient, weighting 132.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood urea increased, cerebral haemorrhage, condition aggravated, disseminated intravascular coagulation, febrile neutropenia, hypernatraemia, pneumonia, renal impairment. MYLOTARG dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, ROXATIDINE ACETATE, GLUCOSEECTION, DIFLUCAN, VITAMEDIN, SOLDEM, STRONG NEO MINOPHAGEN C. Patient was hospitalized. Patient died on 02/23/2007.

Mylotarg Side Effects Report #5396951-4
Physician from JAPAN reported MYLOTARG problem on July 19, 2007. Female patient, 74 years of age, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: pulmonary alveolar haemorrhage. MYLOTARG dosage: unknown. Patient died on 07/15/2007.

Mylotarg Side Effects Report #5397497-X
MYLOTARG problem was reported by a Physician from JAPAN on July 19, 2007. Female patient, weighting 101.4 lb, was diagnosed with acute myeloid leukaemia recurrent and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, febrile neutropenia, sepsis, venoocclusive liver disease. MYLOTARG dosage: unknown. Patient died on 06/01/2007.

Mylotarg Side Effects Report #5398106-6
Physician from UNITED STATES reported MYLOTARG problem on July 18, 2007. Female patient, 39 years of age, weighting 127.0 lb, was diagnosed with acute myeloid leukaemia and was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, alanine aminotransferase increased, alpha haemolytic streptococcal infection, aspartate aminotransferase increased, blood creatinine increased, blood culture positive, bradycardia, cardio-respiratory arrest, cerebral haemorrhage. MYLOTARG dosage: 9.7 MG TOTAL DOSE ADMINISTERED. During the same period patient was treated with DAUNORUBICIN, CYTARABINE. Patient was hospitalized. Patient died on 07/23/2007.

Mylotarg Side Effects Report #5398974-8
MYLOTARG problem was reported by a Consumer or non-health professional from UNITED STATES on July 24, 2007. Female patient, weighting 152.6 lb, was treated with MYLOTARG. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, pancreatitis. MYLOTARG dosage: 5 MG. During the same period patient was treated with CYTARABINE, DAUNORUBICIN, ETOPOSIDE, DEXAMETHASONE, PREDNISONE. Patient was hospitalized. Patient recovered.

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