Vidaza Safety Reports submitted to FDA

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Total Vidaza reports: 47.
Vidaza FDA safety alerts: No.
Reported deaths: 25 Reported hospitalizations: 33.
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FDA Reported Vidaza Side Effects: nausea, pneumonia, hypotension, asthenia, anaemia, pancytopenia, condition aggravated, bacterial infection, vomiting, febrile neutropenia, diarrhoea.
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Vidaza Side Effects Report #5207122-6
Consumer or non-health professional from UNITED STATES reported VIDAZA problem on Dec 27, 2006. Female patient, 86 years of age, weighting 126.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: chest pain, gastrooesophageal reflux disease. VIDAZA dosage: unknown. During the same period patient was treated with VERAPAMIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5213880-7
VIDAZA problem was reported by a Physician from UNITED STATES on Jan 05, 2007. Female patient, 55 years of age, weighting 177.5 lb, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, culture urine positive, enterococcal infection, neutropenic sepsis, no therapeutic response, pericardial effusion, pericarditis, sinus tachycardia, staphylococcal infection. VIDAZA dosage: 132.75 MG (75 MG/M2, DAILY X 7 DAYS, SUBCUTANEOUS. During the same period patient was treated with MGCD, FLAGYL, ACYCLOVIR, LEVAQUIN, VORICONAZOLE, COLACE, BENAZEPRIL. Patient was hospitalized. Patient died on 01/08/2007.

Vidaza Side Effects Report #5225220-8
Consumer or non-health professional from PHILIPPINES reported VIDAZA problem on Jan 23, 2007. Female patient, 54 years of age, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: arrhythmia. VIDAZA dosage: unknown. During the same period patient was treated with NASEA, DEPAKOTE. Patient died on 01/18/2007.

Vidaza Side Effects Report #5228738-7
VIDAZA problem was reported by a Physician from UNITED STATES on Jan 19, 2007. Female patient, 55 years of age, weighting 177.5 lb, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiopulmonary failure, culture urine positive, enterococcal infection, hypotension, neutropenic sepsis, no therapeutic response, pericarditis, sinus tachycardia. VIDAZA dosage: 132.75 MG (75 MG/M2,DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with MGCD, FLAGYL, ACYCLOVIR, LEVAQUIN, VORICONAZOLE, COLACE, BENAZEPRIL HYDROCHLORIDE. Patient was hospitalized. Patient died on 01/08/2007.

Vidaza Side Effects Report #5229612-2
Physician from UNITED STATES reported VIDAZA problem on Jan 18, 2007. Male patient, 79 years of age, weighting 140.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: coma, dialysis, haemoglobin decreased, haemorrhage, hypotension, leukopenia, pneumonia. VIDAZA dosage: 75 MG/M2 (130 MG, DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with COUMADIN, LIPITOR, DIGITEX, ATACAND, ARANESP. Patient was hospitalized. Patient died on 02/16/2006.

Vidaza Side Effects Report #5237948-4
VIDAZA problem was reported by a Physician from PHILIPPINES on Feb 01, 2007. Female patient, 54 years of age, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: anaemia, arrhythmia, asthenia, disease progression, platelet count decreased. VIDAZA dosage: 50 MG/M2 (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with NASEA, DEPAKOTE. Patient died on 01/18/2007.

Vidaza Side Effects Report #5241458-8
Physician from UNITED STATES reported VIDAZA problem on Jan 26, 2007. Female patient, 47 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: fungal infection, lung neoplasm, pulmonary embolism. VIDAZA dosage: 40 MG/M2 (DAYS 1 TO 10, EVERY 28 DAYS), SUBCUTANEOUS. Patient recovered.

Vidaza Side Effects Report #5286019-X
VIDAZA problem was reported by a Physician from UNITED STATES on Mar 16, 2007. Male patient, 79 years of age, weighting 181.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: atelectasis, hypotension, hypoxia, pleural effusion, productive cough, renal failure, sepsis, sputum discoloured, sputum purulent. VIDAZA dosage: 75 MG/M2 (DAILY X 5 DAYS), INTRAVENOUS. During the same period patient was treated with METFORMIN, ASPIRIN, DOXYCYCLINE, GUAIFENESIN, POTASSIUM. Patient was hospitalized. Patient died on 03/17/2007.

Vidaza Side Effects Report #5293978-8
Physician from UNITED STATES reported VIDAZA problem on Mar 23, 2007. Female patient, 47 years of age, weighting 135.4 lb, was diagnosed with myelodysplastic syndrome, decreased appetite and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: decreased appetite, fungal infection, hepatic infection, lung neoplasm, pulmonary embolism. VIDAZA dosage: 40 MG/M2 (DAYS 1 TO 10, EVERY 28 DAYS), SUBCUTANEOUS. During the same period patient was treated with MEGACE, ATIVAN, VFEND, CASPOFUNGIN. Patient recovered.

Vidaza Side Effects Report #5343436-7
VIDAZA problem was reported by a Physician from UNITED KINGDOM on May 17, 2007. Male patient, 55 years of age, weighting 188.7 lb, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: blood culture positive, blood pressure systolic decreased, condition aggravated, neutropenic sepsis, pseudomonas infection, refusal of treatment by patient, sputum culture positive, white blood cell count decreased. VIDAZA dosage: 75 MG/M2 (150 MG ONCE DAILY X FIVE DAYS), SUBCUTANEOUS. During the same period patient was treated with VALPROATE, THEOPHYLLINE, ATRA, VALACYCLOVIR, METRONIDAZOLE, ADCORTYL IN ORAL BASE, AMILORIDE. Patient was hospitalized. Patient died on 05/09/2007.

Vidaza Side Effects Report #5354898-3
Physician from UNITED STATES reported VIDAZA problem on June 04, 2007. Male patient, 79 years of age, weighting 199.1 lb, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, asthenia, blood potassium decreased, crepitations, decreased appetite, discomfort, dyspnoea exertional, fatigue. VIDAZA dosage: 50 MG/M2 (DAYS 1 THROUGH 10, EVERY 28 DAYS), SUBCUTANEOUS. During the same period patient was treated with LASIX, COLACE, SENOKOT, NEURONTIN, PENICILLIN. Patient died on 04/26/2007.

Vidaza Side Effects Report #5367782-6
VIDAZA problem was reported by a Physician from UNITED KINGDOM on June 04, 2007. Male patient, 65 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: anaemia, haemolysis, nausea, polychromasia, red blood cell spherocytes present. VIDAZA dosage: 75 MG/M2 (DAILY X 5 DAYS), INTRAVENOUS. During the same period patient was treated with LEVOTHYROXINE, ACYCLOVIR. Patient recovered.

Vidaza Side Effects Report #5049253-X
Pharmacist from UNITED STATES reported VIDAZA problem on June 26, 2006. Male patient was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: splenic rupture, splenomegaly. VIDAZA dosage: unknown. Patient recovered.

Vidaza Side Effects Report #5060546-2
VIDAZA problem was reported by a Consumer or non-health professional from UNITED STATES on July 19, 2006. Male patient, 79 years of age, weighting 140.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, haemorrhage, pneumonia, sepsis. VIDAZA dosage: unknown. During the same period patient was treated with LIPITOR, ATIVAN. Patient was hospitalized. Patient died on 02/16/2006.

Vidaza Side Effects Report #5071698-2
Physician from UNITED STATES reported VIDAZA problem on July 27, 2006. Male patient, 58 years of age, weighting 172.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: colitis, ileus, intestinal obstruction, pancreatitis. VIDAZA dosage: 75 MG/M2 (140 MG) SUBCUTANEOUS. During the same period patient was treated with ACETAMINOPHEN, PROCHLORPERAZINE MALEATE, IPRATROPIUM. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5077823-1
VIDAZA problem was reported by a Physician from UNITED STATES on July 24, 2006. Female patient, 61 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: gastric perforation, septic shock. VIDAZA dosage: 75 MG/M2 (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with METOPROLOL. Patient was hospitalized. Patient died on 07/11/2006.

Vidaza Side Effects Report #5084852-0
Physician from KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF reported VIDAZA problem on Aug 03, 2006. Female patient, 74 years of age, weighting 101.4 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: asthenia, diarrhoea, epistaxis, febrile neutropenia, hyponatraemia, meningitis bacterial, pancytopenia, pneumonia. VIDAZA dosage: 100 MG (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with FOSAMAX. Patient was hospitalized. Patient died on 05/14/2006.

Vidaza Side Effects Report #5097684-4
VIDAZA problem was reported by a Physician from THAILAND on Aug 24, 2006. Male patient, 33 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: infection, nausea, neutropenia, vomiting. VIDAZA dosage: 100 MG (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with LPRC, ONDANSETRON. Patient was hospitalized. Patient died on 07/01/2006.

Vidaza Side Effects Report #5120147-4
Physician from THAILAND reported VIDAZA problem on Sept 14, 2006. Male patient, 33 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: diarrhoea, haematocrit decreased, lobar pneumonia, lymphocyte percentage increased, nausea, neutropenia, platelet count decreased, septic shock. VIDAZA dosage: 100 MG (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with LPRC, ONDANSETRON. Patient was hospitalized. Patient died on 07/01/2006.

Vidaza Side Effects Report #5128618-1
VIDAZA problem was reported by a Physician from UNITED STATES on Sept 26, 2006. Male patient, 51 years of age, weighting 244.9 lb, was diagnosed with metastatic malignant melanoma and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: arthropod sting, iritis, local swelling. VIDAZA dosage: 75 MG/M2 (DAILY X 3 DAYS EVERY 2 WEEKS), SUBCUTANEOUS. During the same period patient was treated with INTERFERON, AMBIEN CR, FERROUS SULPHATE, PERCOCET, SYNTHROID. Patient recovered.

Vidaza Side Effects Report #5144297-1
Consumer or non-health professional from UNITED STATES reported VIDAZA problem on Oct 18, 2006. Female patient, 71 years of age, weighting 150.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, caecitis, vomiting. VIDAZA dosage: unknown. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5145543-0
VIDAZA problem was reported by a Physician from UNITED STATES on Oct 17, 2006. Female patient, 79 years of age, weighting 183.4 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: anaemia, dilatation atrial, epistaxis, thrombocytopenia, ventricular extrasystoles, ventricular hypertrophy. VIDAZA dosage: 75 MG/M2 (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with MGCD, SPIRIVA, ADVAIR DISKUS, FLONASE, ALLEGRA, ZOLOFT, FOLATE, METAMUCIL. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5146393-1
Physician from UNITED STATES reported VIDAZA problem on Oct 19, 2006. Male patient, 75 years of age, weighting 182.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: amyotrophic lateral sclerosis, bedridden, blood product transfusion dependent, gait disturbance, nerve injury, polyneuropathy. VIDAZA dosage: unknown. During the same period patient was treated with SIMVASTATIN. Patient recovered.

Vidaza Side Effects Report #5154593-X
VIDAZA problem was reported by a Physician from ITALY on Oct 26, 2006. Female patient, 66 years of age, weighting 130.1 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: cerebral ischaemia, coma hepatic, hepatic failure, hepatic necrosis, pneumonia. VIDAZA dosage: 60 MG/M2 (100 MG, DAILY X 8 DAYS, WITHOUT WEEKEND DOSING), SUBCUTANEOUS. During the same period patient was treated with VALPROIC ACID, TRETINOIN, DANAZOLE. Patient died.

Vidaza Side Effects Report #5166006-2
Health Professional from UNITED STATES reported VIDAZA problem on Nov 16, 2006. Female patient, 47 years of age, weighting 115.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: pancreatitis. VIDAZA dosage: 56 MG/M2 (88 MG, DAILY), SUBCUTANEOUS. During the same period patient was treated with ZOLOFT, QUINAPRIL, PRAVASTATIN, NISOLDIPINE, LORATADINE. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5166385-6
VIDAZA problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 15, 2006. Male patient, 79 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: haemorrhage, pneumonia, renal failure, sepsis. VIDAZA dosage: unknown. Patient was hospitalized. Patient died on 02/01/2006.

Vidaza Side Effects Report #5170131-X
Physician from UNITED STATES reported VIDAZA problem on Nov 16, 2006. Female patient, 47 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: atelectasis, cardiac arrest, carotid artery aneurysm, carotid artery atheroma, constipation, electrocardiogram qt corrected interval prolonged, febrile neutropenia, hypokalaemia, hypomagnesaemia. VIDAZA dosage: 40 MG/M2 (DAYS 1 TO 10, EVERY 28 DAYS), SUBCUTANEOUS. During the same period patient was treated with AMBISOME, NORFLOXACIN, ZOFRAN, REGLAN, BENADRYL, PROTONIX, TYLENOL. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5178223-6
VIDAZA problem was reported by a Physician from KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF on Nov 24, 2006. Female patient, 68 years of age, weighting 72.75 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: ascites, bone marrow failure, nausea, peritonitis, pneumonia, vomiting. VIDAZA dosage: 75 MG/M2 (DAILY X 7. Patient was hospitalized. Patient died on 11/18/2006.

Vidaza Side Effects Report #5178225-X
Physician from PHILIPPINES reported VIDAZA problem on Nov 23, 2006. Male patient was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: disease progression. VIDAZA dosage: 100 MG (DAILY X 7 DAYS), SUBCUTANEOUS. Patient died.

Vidaza Side Effects Report #5187668-X
VIDAZA problem was reported by a Physician from UNITED STATES on Nov 28, 2006. Male patient, 75 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: bacterial infection, bronchial obstruction, pancytopenia, pneumonia fungal, sputum culture positive. VIDAZA dosage: 75 MG/M2 (DAILY X 5 DAYS), INTRAVENOUS. During the same period patient was treated with FORTAZ, FLEXERIL, AVODART, LOTEMAX, PROTONIX, ZOCOR, BENADRYL, TYLENOL. Patient was hospitalized. Patient died on 12/05/2006.

Vidaza Side Effects Report #5189382-3
Health Professional from FRANCE reported VIDAZA problem on Dec 01, 2006. Male patient, 65 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, bone marrow transplant, bronchopulmonary aspergillosis, condition aggravated, febrile bone marrow aplasia, pancytopenia. VIDAZA dosage: 75 MG/M2 (DAILY X 6 DAYS), SUBCUTANEOUS. During the same period patient was treated with DANATROL, ARANESP. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5191605-1
VIDAZA problem was reported by a Physician from ITALY on Dec 04, 2006. Female patient, 66 years of age, weighting 130.1 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: cerebral ischaemia, coagulopathy, coma hepatic, condition aggravated, hepatic failure, hepatic necrosis, hepatotoxicity, international normalised ratio increased, neutrophil count decreased. VIDAZA dosage: 60 MG/M2 (100 MG, DAILY X 8 DAYS, WITHOUT WEEKEND DOSING), SUBCUTANEOUS. During the same period patient was treated with VALPROIC ACID, DANAZOLE, TRETINOIN. Patient died on 10/24/2006.

Vidaza Side Effects Report #5193880-6
Physician from UNITED STATES reported VIDAZA problem on Dec 19, 2006. Male patient, 74 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: hypotension, hypoxia, interstitial lung disease, supraventricular tachycardia. VIDAZA dosage: (85 MG, DAILY X 10 DAYS), SUBCUTANEOUS. During the same period patient was treated with TOPROL, FOLTX, ZOLOFT, CARDURA, ZYRTEC, ARANESP. Patient was hospitalized. Patient died on 10/23/2006.

Vidaza Side Effects Report #5195824-X
VIDAZA problem was reported by a Physician from UNITED STATES on Dec 14, 2006. Female patient, 69 years of age, weighting 158.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: asthenia, bacteria stool identified, bacterial infection, blood pressure decreased, catheter sepsis, condition aggravated, heart rate decreased, heart rate increased, nausea. VIDAZA dosage: 75 MG/M2 (DAILY X 5 DAYS), INTRAVENOUS. During the same period patient was treated with ZOLOFT, XANAX, ASCORBIC ACID, IRON, CYANOCOBALAMIN, SPIRIVA, ALBUTEROL. Patient was hospitalized. Patient died on 12/12/2006.

Vidaza Side Effects Report #5380511-5
Physician from UNITED KINGDOM reported VIDAZA problem on June 21, 2007. Male patient, 65 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: anaemia, nausea, polychromasia, red blood cell spherocytes present. VIDAZA dosage: 75 MG/M2 (DAILY X 5 DAYS),INTRAVENOUS. During the same period patient was treated with LEVOTHYROXINE, ACYCLOVIR. Patient recovered.

Vidaza Side Effects Report #5385214-9
VIDAZA problem was reported by a Physician from UNITED KINGDOM on June 22, 2007. Male patient, 68 years of age, weighting 154.3 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: abscess intestinal. VIDAZA dosage: (75 MG/M2, SUBCUTANEOUS. During the same period patient was treated with CIPROFLOXACIN, NYSTATIN, ACYCLOVIR. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5397276-3
Physician from GERMANY reported VIDAZA problem on July 09, 2007. Male patient, 55 years of age, weighting 165.3 lb, was diagnosed with acute myeloid leukaemia, prophylaxis of nausea and vomiting and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: aggression. VIDAZA dosage: 75 MG/M2 (DAILY X 5 DAYS), SUBCUTANEOUS. During the same period patient was treated with ONDANSETRON. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5398952-9
VIDAZA problem was reported by a Pharmacist from UNITED STATES on July 24, 2007. Female patient, 81 years of age, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: pancytopenia. VIDAZA dosage: unknown. During the same period patient was treated with TYLENOL, HEPARIN, AZTREONAM, CIPROFLOXACIN, ALBUTEROL, IPRATROPIUM BROMIDE, BACTRIM, VANCOMYCIN. Patient was hospitalized. Patient died on 04/04/2006.

Vidaza Side Effects Report #5402040-2
Physician from FRANCE reported VIDAZA problem on July 12, 2007. Male patient, 55 years of age, weighting 220.5 lb, was diagnosed with myelodysplastic syndrome, thrombosis prophylaxis, pyrexia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: bacterial infection, catheter related infection, culture urine positive, escherichia infection, international normalised ratio increased, pneumonia klebsiella, sepsis. VIDAZA dosage: 120 MG (DAILY X 5 DAYS), SUBCUTANEOUS. During the same period patient was treated with PREVISCAN, AMOXICILLIN, ATENOLOL. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5413136-3
VIDAZA problem was reported by a Physician from UNITED STATES on July 26, 2007. Female patient, 78 years of age, weighting 140.2 lb, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: cystitis haemorrhagic, thrombocytopenia, urinary tract infection. VIDAZA dosage: 75 MG/M2 (DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with MGCD, ATENOLOL. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5422042-X
Physician from UNITED STATES reported VIDAZA problem on Aug 03, 2007. Female patient, 80 years of age, weighting 145.0 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: asthenia, carotid arteriosclerosis, haemoglobin decreased, heart rate irregular, hypotension, iron overload, local swelling, loss of consciousness, pyrexia. VIDAZA dosage: 75 MG/M2, INTRAVENOUS. During the same period patient was treated with HYDROCHLOROTHIAZIDE, ENALAPRIL, METOPROLOL TARTRATE, ASPIRIN, DEFERASIROX. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5422150-3
VIDAZA problem was reported by a Physician from UNITED KINGDOM on Aug 03, 2007. Male patient, 55 years of age, weighting 149.7 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: atrial flutter, chest x-ray abnormal, diarrhoea, disease recurrence, hypertension, hypotension, pyrexia, tachycardia. VIDAZA dosage: 135 MG (DAILY X 5 DAYS), SUBCUTANEOUS. During the same period patient was treated with VALPROATE, THEOPHYLLINE, CIPROFLOXACIN, ACYCLOVIR, ALLOPURINOL, PENICILLIN V, LANSOPRAZOLE. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5443288-0
Physician from GERMANY reported VIDAZA problem on Aug 16, 2007. Male patient, 59 years of age, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: anaemia, aplasia, atrial fibrillation, catheter site haemorrhage, convulsion, febrile neutropenia, haemoptysis, left ventricular failure. VIDAZA dosage: (100 MG/M2), SUBCUTANEOUS. During the same period patient was treated with VALPROIC ACID, NEUPOGEN. Patient was hospitalized. Patient died on 07/15/2007.

Vidaza Side Effects Report #5449798-4
VIDAZA problem was reported by a Physician from ITALY on Aug 29, 2007. Male patient, 72 years of age, weighting 158.7 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, aspergillosis, blood pressure increased, cytomegalovirus infection, epstein-barr virus infection, heart rate increased, pneumocystis jiroveci pneumonia, urinary retention. VIDAZA dosage: (140 MG, DAILY X 7). During the same period patient was treated with VALPROIC ACID. Patient was hospitalized. Patient died on 08/24/2007.

Vidaza Side Effects Report #5455009-6
Physician from FRANCE reported VIDAZA problem on Aug 28, 2007. Female patient, 76 years of age, weighting 136.7 lb, was diagnosed with acute myeloid leukaemia and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: encephalopathy. VIDAZA dosage: 119.3 MG (119.3 MG, DAILY X 7 DAYS), INTRAVENOUS. During the same period patient was treated with VALPROIC ACID, PROPRANOLOL, LEVOTHYROXINE, DESLORATADINE, GINKGO BILOBA. Patient was hospitalized and became disabled. Patient recovered.

Vidaza Side Effects Report #5467580-9
VIDAZA problem was reported by a Physician from UNITED STATES on Sept 07, 2007. Male patient, 43 years of age, weighting 242.5 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute febrile neutrophilic dermatosis, post procedural haematoma, renal failure, respiratory failure, sepsis, vocal cord disorder. VIDAZA dosage: (75 MG/M2, DAILY X 7 DAYS), SUBCUTANEOUS. During the same period patient was treated with VORINOSTAT. Patient was hospitalized. Patient recovered.

Vidaza Side Effects Report #5472682-7
Physician from ITALY reported VIDAZA problem on Sept 11, 2007. Female patient, 61 years of age, weighting 143.3 lb, was diagnosed with myelodysplastic syndrome and was treated with VIDAZA. After drug was administered, patient experienced the following problems/side effects: blood culture positive, candidiasis, depressed level of consciousness, neutropenia, pneumonia fungal, septic shock. VIDAZA dosage: (125 MG, DAILY X DAYS), SUBCUTANEOUS. During the same period patient was treated with VALPROIC ACID, EUTIROX, VALPRESSION. Patient died on 09/02/2007.

Drug Information: Azacitidine Injection

URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a607068.html

(ay za site' i deen)

Why is this medication prescribed?

Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

How should this medicine be used?

Azacitidine comes as a powder to be mixed with water and injected subcutaneously (under the skin) or intravenously (into a vein) by a doctor or nurse in a medical office or hospital outpatient department. It is usually injected once a day for 7 days. This treatment may be repeated every 4 weeks for as long as your doctor recommends. Treatment should usually be given for at least four cycles.

Your doctor may increase your dose of azacitidine after two cycles if your condition has not improved and if you have not experienced serious side effects of the medication. Your doctor may also need to delay your treatment or reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with azacitadine.

Your doctor will give you medication to prevent nausea and vomiting before you receive each dose of azacitadine.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using azacitidine,

tell your doctor and pharmacist if you are allergic to azacitidine, mannitol (Osmitrol, Resectisol), or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have a liver tumor. Your doctor may tell you not to take azacitidine.
tell your doctor if you have or have ever had liver or kidney disease.
tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using azacitidine. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with azacitidine. Talk to your doctor about birth control methods that will work for you. If you or your partner become pregnant while using azacitidine, call your doctor. Azacitidine may harm the fetus.
do not breastfeed while you are using azacitidine.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using azacitidine.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Call your doctor right away if you are unable to keep an appointment to receive a dose of azacitidine.

What side effects can this medication cause?

Azacitidine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

nausea
vomiting
diarrhea
constipation
sores on the mouth or tongue
hemorrhoids
stomach pain or tenderness
heartburn
loss of appetite
weight loss
headache
dizziness
weakness
excessive tiredness
difficulty falling asleep or staying asleep
depression
anxiety
back, muscle, or joint pain
muscle cramps
sweating
night sweats
difficulty urinating or pain when urinating
swelling of the hands, feet, ankles, or lower legs
dry skin
redness, pain, bruising, swelling, itching, lump, or change in the skin color in the place where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

pale skin
shortness of breath
fast heartbeat
chest pain
cough
unusual bruising or bleeding
nosebleeds
bleeding gums
small red or purple dots on the skin
sore throat, fever, chills, or other signs of infection
hives
rash
itching
difficulty breathing or swallowing

Azacitidine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What storage conditions are needed for this medicine?

This medication will be stored in the medical office or hospital where you receive your treatment.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

diarrhea
nausea
vomiting

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to azacitidine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand name(s):

Vidaza®

Other name(s):

Ladakamycin

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