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Review Novantrone Safety Reports submitted to FDA

Total Novantrone reports: 278.
Novantrone FDA safety alerts: 2005 .
Reported deaths: 81    Reported hospitalizations: 139.
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FDA Reported Novantrone Side Effects: ejection fraction decreased, febrile neutropenia, acute myeloid leukaemia, septic shock, cardiac failure congestive, platelet count decreased, diarrhoea, anaemia, pancytopenia, myocardial infarction, neutropenia.
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Novantrone Side Effects Report #5334429-4
Physician from UNITED STATES reported NOVANTRONE problem on May 09, 2007. Female patient, 60 years of age, weighting 170.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: carbohydrate antigen 125 increased, clostridial infection, ovarian cancer, weight decreased, white blood cell count decreased. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5334449-X
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on May 14, 2007. Female patient, 42 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. NOVANTRONE dosage: unknown. Patient died on 04/20/2007.

Novantrone Side Effects Report #5334483-X
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on May 08, 2007. Female patient, 46 years of age, weighting 118.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with REBIF, FLUOXETINE. Patient recovered.

Novantrone Side Effects Report #5334497-X
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on May 11, 2007. Male patient, 42 years of age, weighting 140.0 lb, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, bacterial infection, blood ph decreased, clostridium difficile colitis, constipation, full blood count decreased, hypovolaemia, megacolon, mucosal inflammation. NOVANTRONE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTARABINE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5336325-5
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on May 14, 2007. Male patient, 66 years of age, weighting 153.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with AVONEX, HYZAAR, GLIPIZIDE. Patient recovered.

Novantrone Side Effects Report #5337670-X
NOVANTRONE problem was reported by a Physician from UNITED STATES on May 15, 2007. Female patient, 45 years of age, weighting 240.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cholecystitis. NOVANTRONE dosage: 12 MG/M2, 1 IN 3 MONTHS, INTRAVENOUS (NOT SPECIFIED). During the same period patient was treated with KEPPRA, TOPAMAX, SEROQUEL, ZANAFLEX, BACLOFEN, NEURONTIN, LYRICA. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5341529-1
Consumer or non-health professional from FRANCE reported NOVANTRONE problem on May 15, 2007. Female patient, 47 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia. NOVANTRONE dosage: 20 MG, 1 IN 1 CYCLE, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with IMURAN. Patient recovered.

Novantrone Side Effects Report #5290165-4
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Mar 22, 2007. Female patient, 66 years of age, weighting 116.0 lb, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, cyanosis, dyspnoea, febrile neutropenia, fluid overload, haemoptysis, immune system disorder, loss of consciousness, lung infiltration. NOVANTRONE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTARABINE, ACYCLOVIR, ALLOPURINOL, CALCIUM CARBONATE, CEFEPIME, NYSTATIN, PROTONIX. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5290224-6
Physician from UNITED STATES reported NOVANTRONE problem on Mar 23, 2007. Male patient, 58 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: blast cell crisis, leukaemia, tachycardia. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5291914-1
NOVANTRONE problem was reported by a Consumer or non-health professional from NETHERLANDS on Mar 26, 2007. Female patient, 71 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, respiratory arrest. NOVANTRONE dosage: 200 MG. During the same period patient was treated with CYTARABINE, ETOPOSIDE, IDARUBICIN, VANCOMYCIN, CIPROFLOXACIN. Patient died on 02/16/2005.

Novantrone Side Effects Report #5291916-5
Consumer or non-health professional from ITALY reported NOVANTRONE problem on Mar 26, 2007. Female patient, 63 years of age, weighting 154.3 lb, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased, lung infection, platelet count decreased, red blood cell count decreased, respiratory failure, staphylococcal infection, white blood cell count decreased. NOVANTRONE dosage: 12 MG. During the same period patient was treated with GEMTUZUMAB, CYTARABINE, ETOPOSIDE, LEVOFLOXACIN. Patient died on 02/02/2005.

Novantrone Side Effects Report #5292201-8
NOVANTRONE problem was reported by a Consumer or non-health professional from ITALY on Mar 27, 2007. Female patient, 70 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, mucosal inflammation, rectal haemorrhage, septic shock, stenotrophomonas sepsis. NOVANTRONE dosage: unknown. During the same period patient was treated with CYTARABINE, CEFTAZIDIME, AMIKACIN, TEICOPLANIN, VORICONAZOLE. Patient died.

Novantrone Side Effects Report #5293777-7
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 21, 2007. Female patient, weighting 138.9 lb, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute promyelocytic leukaemia. NOVANTRONE dosage: unknown. During the same period patient was treated with OXYBUTYNIN CHLORIDE, CARBAMAZEPINE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5298526-4
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Apr 02, 2007. Male patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: agitation, cerebellar infarction, disorientation, enterococcal infection, febrile neutropenia, haemodynamic instability, herpes simplex, hypertension, hypotension. NOVANTRONE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTARABINE. Patient was hospitalized. Patient died on 03/15/2007.

Novantrone Side Effects Report #5298628-2
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 27, 2007. Male patient, 63 years of age, weighting 149.9 lb, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, clostridium difficile colitis, coronary artery occlusion, coronary artery stenosis, dilatation atrial, no therapeutic response, procedural hypotension, ventricular hypertrophy. NOVANTRONE dosage: 21 MG, 1 IN 3 MONTHS. During the same period patient was treated with FELODIPINE, ACETYLSALICYLIC ACID SRT, BENAZEPRIL HYDROCHLORIDE, MORNIFLUMATE, SIMVASTATIN, TEMAZEPAM, GABAPENTIN, IBUPROFEN. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5299729-5
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Apr 02, 2007. Male patient, 51 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, disseminated intravascular coagulation, dysphagia, hepatic function abnormal, herpes simplex, hypoalbuminaemia, hypokalaemia, mouth haemorrhage. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, POLYMYXIN B SULPHATE, FAMOTIDINE, BACTRIM, ALLOPURINOL, VORICONAZOLE. Patient was hospitalized. Patient died on 10/15/2006.

Novantrone Side Effects Report #5299731-3
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 29, 2007. Male patient, 64 years of age, was diagnosed with prostate cancer and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, dyspnoea, malignant neoplasm progression, prostate cancer. NOVANTRONE dosage: 12 MG/M2, 1 IN 21 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with DOCETAXEL, IROFULVEN, CAPECITABINE. Patient died.

Novantrone Side Effects Report #5302418-1
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 05, 2007. Male patient, child 7 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiac failure, chills, disseminated intravascular coagulation, hepatic function abnormal, hypoxia, pericardial effusion, pleural effusion, tumour lysis syndrome. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, IDARUBICIN, PIRARUBICIN, CYTARABINE, LENOGRASTIM. Patient was hospitalized. Patient died on 03/29/2006.

Novantrone Side Effects Report #5305083-2
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Apr 09, 2007. Female patient, 49 years of age, weighting 130.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased, extrasystoles, nausea, osteoporosis. NOVANTRONE dosage: 19 MG, 1 IN 3 MONTHS, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with BACLOFEN, DECADRON. Patient recovered.

Novantrone Side Effects Report #5305120-5
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 07, 2007. Female patient, 46 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: malaise, vomiting. NOVANTRONE dosage: unknown. During the same period patient was treated with REBIF. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5306507-7
Consumer or non-health professional from JAPAN reported NOVANTRONE problem on Apr 10, 2007. Female patient, 83 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, febrile neutropenia, pneumonia. NOVANTRONE dosage: 6 MG, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with MYLOTARG, CYTARABINE, FLUDARABINE PHOSPHATE, FLUCONAZOLE, AMPHOTERICIN B, LEVOFLOXACIN, ITRACONAZOLE. Patient recovered.

Novantrone Side Effects Report #5306508-9
NOVANTRONE problem was reported by a Consumer or non-health professional from ITALY on Apr 10, 2007. Male patient, 65 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: pulmonary alveolar haemorrhage. NOVANTRONE dosage: 39 MG. During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient recovered.

Novantrone Side Effects Report #5306509-0
Consumer or non-health professional from FRANCE reported NOVANTRONE problem on Apr 06, 2007. Female patient, 52 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. NOVANTRONE dosage: 20 MG, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with REBIF, METHYLPREDNISOLONE SUCCINATE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5306519-3
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Apr 12, 2007. Male patient, 62 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, hyperphosphataemia, renal impairment. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, IDARUBICIN. Patient recovered.

Novantrone Side Effects Report #5307759-X
Health Professional from UNITED STATES reported NOVANTRONE problem on Apr 09, 2007. Female patient, 43 years of age, weighting 120.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: catheter related infection, sepsis. NOVANTRONE dosage: unknown. During the same period patient was treated with REBIF. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5309160-1
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Apr 09, 2007. Female patient, 42 years of age, weighting 135.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with REBIF, IBUPROFEN. Patient recovered.

Novantrone Side Effects Report #5312815-6
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Apr 10, 2007. Female patient, 53 years of age, weighting 180.8 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea, ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with KEPPRA, ANTIDEPRESSANTS. Patient recovered.

Novantrone Side Effects Report #5313506-8
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Apr 18, 2007. Male patient, 28 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, chills, condition aggravated, diarrhoea, epistaxis, headache, hepatic function abnormal, mucous membrane disorder. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, IDARUBICIN, GRANISETRON, HYDROCORTISONE SUCCINATE, HEPARIN. Patient was hospitalized. Patient died on 09/02/2006.

Novantrone Side Effects Report #5313509-3
Consumer or non-health professional from JAPAN reported NOVANTRONE problem on Apr 12, 2007. Male patient, 56 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, anaemia, blood alkaline phosphatase abnormal, disease progression, febrile neutropenia, gingival bleeding, hypersensitivity, hypoalbuminaemia, lymphocyte count decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, ENOCITABINE, KELFIPRIM, ITRACONAZOLE, ALLOPURINOL. Patient recovered.

Novantrone Side Effects Report #5315173-6
NOVANTRONE problem was reported by a Consumer or non-health professional from GERMANY on Apr 18, 2007. Female patient, 51 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: accidental exposure, atrioventricular block complete, breast pain, contusion, dyspnoea, facial bones fracture, fall, loss of consciousness, nausea. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5315177-3
Consumer or non-health professional from GERMANY reported NOVANTRONE problem on Apr 20, 2007. Male patient, 69 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, bronchopulmonary aspergillosis, respiratory failure, staphylococcal infection. NOVANTRONE dosage: 14 MG. During the same period patient was treated with CYTARABINE. Patient was hospitalized. Patient died on 04/12/2004.

Novantrone Side Effects Report #5315183-9
NOVANTRONE problem was reported by a Consumer or non-health professional from GERMANY on Apr 20, 2007. Male patient, 72 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: peritoneal effusion, pleural effusion, pneumonia fungal, sepsis. NOVANTRONE dosage: 14 MG, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient died on 09/27/2006.

Novantrone Side Effects Report #5315184-0
Consumer or non-health professional from ITALY reported NOVANTRONE problem on Apr 20, 2007. Male patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, sepsis. NOVANTRONE dosage: 10 MG, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with CYTARABINE, ETOPOSIDE, INSULIN. Patient died on 04/06/2007.

Novantrone Side Effects Report #5315185-2
NOVANTRONE problem was reported by a Consumer or non-health professional from GERMANY on Apr 19, 2007. Male patient, 65 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: fungal infection. NOVANTRONE dosage: 14 MG. During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient died on 07/03/2005.

Novantrone Side Effects Report #5315264-X
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Apr 18, 2007. Male patient, 51 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, disseminated intravascular coagulation, dysphagia, dysphasia, eating disorder, hepatic function abnormal, herpes simplex. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, POLYMYXIN B SULPHATE, FAMOTIDINE, BACTRIM, ALLOPURINOL, VORICONAZOLE. Patient was hospitalized. Patient died on 10/15/2006.

Novantrone Side Effects Report #5255844-3
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Feb 14, 2007. Female patient, 83 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, febrile neutropenia, leukaemia recurrent. NOVANTRONE dosage: 6 MG, 1 IN 1 DAYS, INTRAVENOUS. During the same period patient was treated with MYLOTARG, CYTARABINE, FLUDARABINE PHOSPHATE, FLUCONAZOLE, AMPHOTERICIN B, LEVOFLOXACIN, ITRACONAZOLE. Patient recovered.

Novantrone Side Effects Report #5256345-9
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Feb 21, 2007. Female patient was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: chromaturia, fall, hip fracture, urinary incontinence, urine odour abnormal. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5261724-X
NOVANTRONE problem was reported by a Consumer or non-health professional from ITALY on Feb 26, 2007. Female patient, 67 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, escherichia sepsis, multi-organ failure, septic shock. NOVANTRONE dosage: 10 MG. During the same period patient was treated with CYTARABINE, ETOPOSIDE, AMIKACIN, PIPERACILLIN, TAZOBACTAM. Patient died.

Novantrone Side Effects Report #5261965-1
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Feb 27, 2007. Female patient, 47 years of age, weighting 110.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased, oedema peripheral. NOVANTRONE dosage: 20 MG, 1 IN 3 MONTHS, INTRAVENOUS. During the same period patient was treated with PREDNISONE, CLONAZEPAM. Patient recovered.

Novantrone Side Effects Report #5261968-7
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 27, 2007. Female patient, 64 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, haemoglobin decreased, ulcer, urinary tract infection, weight decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with ATENOLOL, ZOCOR, ZOLOFT, CLONAPIN, BACTRIM. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5261981-X
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Feb 27, 2007. Female patient, 25 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: blood disorder, infection, musculoskeletal stiffness, thrombosis. NOVANTRONE dosage: unknown. During the same period patient was treated with BACLOFEN, COUMADIN. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5261997-3
NOVANTRONE problem was reported by a Physician from UNITED STATES on Feb 26, 2007. Female patient, 53 years of age, weighting 132.3 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: oral neoplasm, papilloma, squamous cell carcinoma. NOVANTRONE dosage: unknown. Patient recovered.

Novantrone Side Effects Report #5264105-8
Consumer or non-health professional from GERMANY reported NOVANTRONE problem on Feb 23, 2007. Female patient, 38 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: dysarthria, hemiparesis. NOVANTRONE dosage: 18.5 MG, INTRAVENOUS (NOT OTHERWISE SPECIFIED). Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5264121-6
NOVANTRONE problem was reported by a Consumer or non-health professional from BELGIUM on Mar 01, 2007. Male patient, 69 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis, enterocolitis, neutropenia, septic shock. NOVANTRONE dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient was hospitalized. Patient died on 02/17/2007.

Novantrone Side Effects Report #5266725-3
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 01, 2007. Male patient, 56 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, blood alkaline phosphatase abnormal, febrile neutropenia, gingival bleeding, haemoglobin decreased, hypersensitivity, hypoalbuminaemia, lymphocyte count decreased, malignant neoplasm progression. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, ENOCITABINE, KELFIPRIM, ITRACONAZOLE. Patient recovered.

Novantrone Side Effects Report #5266784-8
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Mar 02, 2007. Female patient, 56 years of age, weighting 116.8 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: basal cell carcinoma. NOVANTRONE dosage: unknown. During the same period patient was treated with LEVOTHYROXINE, RISEDRONATE, ALENDRONATE, CALCIUM CARBONATE, CARBAMAZEPINE, OESTRANORM, CLONAZEPAM. Patient recovered.

Novantrone Side Effects Report #5268369-6
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 02, 2007. Male patient, 38 years of age, weighting 215.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with AMANTADINE, BACLOFEN, PROVIGIL. Patient recovered.

Novantrone Side Effects Report #5270438-1
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Mar 01, 2007. Male patient, 28 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: anaemia, chills, condition aggravated, diarrhoea, epistaxis, headache, hepatic function abnormal, mucous membrane disorder, neutrophil count decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, IDARUBICIN, GRANISETRON, HYDROCORTISONE SUCCINATE, HEPARIN. Patient was hospitalized. Patient died on 09/02/2006.

Novantrone Side Effects Report #5270439-3
Consumer or non-health professional from JAPAN reported NOVANTRONE problem on Mar 05, 2007. Female patient, 20 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: anorexia, blood fibrinogen increased, cardiotoxicity, cystitis haemorrhagic, electrocardiogram qt corrected interval prolonged, electrocardiogram qt prolonged, fungal sepsis, hepatic function abnormal. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, ETOPOSIDE, HYDROCORTISONE SUCCINATE, ITRACONAZOLE, BACTRIM. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5270592-1
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 05, 2007. Female patient, 56 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: fall, hip fracture, upper limb fracture. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5271766-6
Consumer or non-health professional from JAPAN reported NOVANTRONE problem on Mar 09, 2007. Male patient, 71 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, hepatic function abnormal, platelet count decreased, pneumonia, renal failure. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, ETOPOSIDE, FLUCONAZOLE. Patient died on 07/24/2006.

Novantrone Side Effects Report #5271811-8
NOVANTRONE problem was reported by a Consumer or non-health professional from FRANCE on Mar 02, 2007. Male patient, 72 years of age, was diagnosed with prostate cancer recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5271897-0
Consumer or non-health professional from FINLAND reported NOVANTRONE problem on Mar 09, 2007. Female patient, child 5 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, interstitial lung disease. NOVANTRONE dosage: 7 MG, 1 IN 1 DAYS, INTRAVENOUS. During the same period patient was treated with CETIRIZINE HYDROCHLORIDE, FLUTICASONE PROPIONATE, DIFLUCAN, OMEPRAZOLE, PERFALGAN, LAXOBERON, ROCEPHALIN, LEVOLAC. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5272191-4
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 09, 2007. Female patient, 46 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with REBIF. Patient recovered.

Novantrone Side Effects Report #5272575-4
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 07, 2007. Female patient, 57 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: chromaturia, fall, hip fracture, urinary incontinence, urine odour abnormal. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5274457-0
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 08, 2007. Male patient, 59 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, oesophagitis, pancytopenia. NOVANTRONE dosage: unknown. During the same period patient was treated with HYDROXYCARBAMIDE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5274475-2
Health Professional from UNITED STATES reported NOVANTRONE problem on Mar 06, 2007. Male patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, brain oedema, cerebral haemorrhage, confusional state, disorientation, haemoglobin decreased, headache, international normalised ratio increased, no therapeutic response. NOVANTRONE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTARABINE. Patient recovered.

Novantrone Side Effects Report #5274754-9
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Mar 16, 2007. Male patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, cerebral haemorrhage, disease progression, international normalised ratio increased, subarachnoid haemorrhage, white blood cell count decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTARABINE. Patient died on 01/10/2007.

Novantrone Side Effects Report #5276496-2
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Oct 06, 2006. Male patient, 51 years of age, weighting 260.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: multiple sclerosis. NOVANTRONE dosage: unknown. During the same period patient was treated with HYDROCODONE, MARINOL, DURAGESIC. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5278307-8
NOVANTRONE problem was reported by a Physician from UNITED STATES on Mar 12, 2007. Male patient, 38 years of age, weighting 215.0 lb, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with AMANTADINE, BACLOFEN, PROVIGIL. Patient recovered.

Novantrone Side Effects Report #5278308-X
Physician from UNITED STATES reported NOVANTRONE problem on Mar 08, 2007. Female patient, 54 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute promyelocytic leukaemia, anaemia, pancytopenia, subdural haematoma. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5278309-1
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Mar 15, 2007. Female patient, 66 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute promyelocytic leukaemia, cardiac failure congestive, cytomegalovirus infection, gastritis, pancytopenia, sepsis. NOVANTRONE dosage: unknown. Patient was hospitalized. Patient died on 03/13/2007.

Novantrone Side Effects Report #5278310-8
Health Professional from UNITED STATES reported NOVANTRONE problem on Mar 15, 2007. Male patient, 63 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: MG/M2, 1 IN 3 MONTHS, INTRAVENOUS (NOT OTHERWISE SPECIFIED). Patient recovered.

Novantrone Side Effects Report #5278853-7
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Mar 13, 2007. Female patient, 83 years of age, was diagnosed with acute myeloid leukaemia, acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: disseminated intravascular coagulation, febrile neutropenia, pneumonia. NOVANTRONE dosage: 6 MG, 1 IN 1 DAYS, INTRAVENOUS. During the same period patient was treated with MYLOTARG, CYTARABINE, FLUDARABINE PHOSPHATE, FLUCONAZOLE, AMPHOTERICIN B, LEVOFLOXACIN, ITRACONAZOLE. Patient recovered.

Novantrone Side Effects Report #5281058-7
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 09, 2007. Male patient, 72 years of age, was diagnosed with prostate cancer metastatic and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cardiac failure, lung infection. NOVANTRONE dosage: unknown. During the same period patient was treated with GONADORELIN, ZOMETA. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5281060-5
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Male patient, 47 years of age, was diagnosed with b-cell lymphoma and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: aplasia, large intestine perforation. NOVANTRONE dosage: 5 MG, 1 IN 1 DAYS, INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with CYTARABINE, DEXAMETHASONE PHOSPHATE. Patient recovered.

Novantrone Side Effects Report #5282579-3
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 15, 2007. Male patient was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: blast cell crisis, leukaemia, pyrexia. NOVANTRONE dosage: 27 MG, 4 COURSE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5282581-1
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 15, 2007. Female patient, 36 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: ejection fraction decreased. NOVANTRONE dosage: unknown. During the same period patient was treated with PROVIGIL. Patient recovered.

Novantrone Side Effects Report #5282594-X
Physician from UNITED STATES reported NOVANTRONE problem on Mar 19, 2007. Male patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: agitation, aspergillosis, blood ph decreased, cerebral infarction, disorientation, enterococcal infection, febrile neutropenia, herpes virus infection, hypertension. NOVANTRONE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CYTARABINE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5283269-3
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Male patient, 35 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: disease progression, sepsis, weight increased. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, ETOPOSIDE, FLUCONAZOLE, ROXATIDINE ACETATE, REBAMIPIDE, ALLOPURINOL. Patient recovered.

Novantrone Side Effects Report #5283996-8
Physician from UNITED STATES reported NOVANTRONE problem on Mar 19, 2007. Female patient, 39 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: mitral valve prolapse, non-cardiac chest pain, oesophageal spasm, secondary progressive multiple sclerosis. NOVANTRONE dosage: unknown. During the same period patient was treated with VITAMIN WITH FOLIC ACID, FOLATE. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5283997-X
NOVANTRONE problem was reported by a Health Professional from UNITED STATES on Mar 15, 2007. Male patient, 46 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cardiomegaly, dyspnoea, ejection fraction decreased, influenza like illness, orthopnoea. NOVANTRONE dosage: unknown. During the same period patient was treated with HIGH DOSE INTRAVENOUS STEROIDS, BACLOFEN PUMP. Patient recovered.

Novantrone Side Effects Report #5285273-8
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 20, 2007. Female patient, 63 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, bone marrow failure, bronchopulmonary aspergillosis, escherichia sepsis, hyperbilirubinaemia, pulmonary infarction. NOVANTRONE dosage: unknown. During the same period patient was treated with CYTARABINE, TAZOBACTAM, AMIKACIN, CORTICOSTEROIDS, ETOPOSIDE. Patient died on 12/10/2004.

Novantrone Side Effects Report #5285389-6
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 20, 2007. Male patient, 70 years of age, was diagnosed with acute myeloid leukaemia and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, sepsis, septic shock, ventricular tachycardia. NOVANTRONE dosage: unknown. During the same period patient was treated with GEMTUZUMAB OZOGAMICIN, CYTARABINE, ETOPOSIDE. Patient died on 12/12/2005.

Novantrone Side Effects Report #5285467-1
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 20, 2007. Male patient, 62 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: pneumonia, pseudomonas infection, septic shock. NOVANTRONE dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE, LEVOFLOXACIN. Patient died on 11/18/2006.

Novantrone Side Effects Report #5286916-5
NOVANTRONE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Female patient, 38 years of age, was diagnosed with multiple sclerosis and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: dysarthria, hemiparesis. NOVANTRONE dosage: 18.5 MG, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Novantrone Side Effects Report #5286917-7
Consumer or non-health professional from UNITED STATES reported NOVANTRONE problem on Mar 22, 2007. Female patient, 68 years of age, was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage, thrombocytopenia. NOVANTRONE dosage: unknown. During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient was hospitalized. Patient died on 05/03/2004.

Novantrone Side Effects Report #5288271-3
NOVANTRONE problem was reported by a Consumer or non-health professional from JAPAN on Mar 23, 2007. Male patient, 51 years of age, was diagnosed with acute myeloid leukaemia recurrent and was treated with NOVANTRONE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, anaemia, disseminated intravascular coagulation, dysphagia, hepatic function abnormal, herpes simplex, hypoalbuminaemia, infection, leukaemic infiltration pulmonary. NOVANTRONE dosage: unknown. During the same period patient was treated with MYLOTARG, CYTARABINE, POLYMYXIN B SULPHATE, FAMOTIDINE, BACTRIM, ALLOPURINOL, VORICONAZOLE. Patient was hospitalized. Patient died on 10/15/2006.

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