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Review Pentostatin Safety Reports submitted to FDA

Total Pentostatin reports: 20.
Pentostatin FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 15.
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FDA Reported Pentostatin Side Effects: diarrhoea, renal failure, cough, hypotension, respiratory failure, pulmonary alveolar haemorrhage, headache, abdominal pain, pyrexia, pneumonia necrotising, bacteraemia.
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Pentostatin Side Effects Report #5663764-5
Consumer or non-health professional from UNITED STATES reported PENTOSTATIN problem on Mar 03, 2008. Male patient, 69 years of age, weighting 151.0 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: anaemia, anaphylactic reaction, transfusion reaction. PENTOSTATIN dosage: 7.24 MG Q3W IV. During the same period patient was treated with CYTOXAN, COMPAZINE, TOPROL, RITUXAN, LIPITOR, PRILOSEC, ASPIRIN, NIACIN. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5681009-7
PENTOSTATIN problem was reported by a Health Professional from UNITED STATES on Mar 17, 2008. Male patient, 69 years of age, weighting 143.0 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: aspiration pleural cavity abnormal, condition aggravated, coronary artery bypass, diarrhoea, hypoxia, neutropenia, oedema peripheral, pancytopenia, pleural effusion. PENTOSTATIN dosage: 7.24 MG 3/WK IV. During the same period patient was treated with CYTOXAN, COMPAZINE, TOPROL, LIPITOR, PRILOSEC, ASPIRIN, NIACIN, FEOSOL. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5597481-7
Pharmacist from UNITED STATES reported PENTOSTATIN problem on Jan 14, 2008. Female patient, 49 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: bacteraemia, renal failure acute, vision blurred. PENTOSTATIN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXAN. Patient died on 01/13/2008.

Pentostatin Side Effects Report #5449661-9
PENTOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 10, 2007. Male patient, weighting 217.4 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, atrial flutter, bacteraemia, graft versus host disease, pulmonary oedema, respiratory failure, septic shock. PENTOSTATIN dosage: 16 MG. Patient recovered.


Pentostatin Side Effects Report #5409030-4
Physician from UNITED STATES reported PENTOSTATIN problem on July 20, 2007. Male patient, weighting 140.9 lb, was diagnosed with graft versus host disease and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: pain. PENTOSTATIN dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5413327-1
PENTOSTATIN problem was reported by a Health Professional from UNITED STATES on Aug 06, 2007. Male patient, weighting 140.9 lb, was diagnosed with graft versus host disease and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: graft versus host disease, pain. PENTOSTATIN dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5390897-3
Physician from UNITED STATES reported PENTOSTATIN problem on July 05, 2007. Male patient, 69 years of age, weighting 150.0 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: cough, dyspnoea, hypoxia, pleural effusion. PENTOSTATIN dosage: 7.24 MG 3/WK IV. During the same period patient was treated with CYTOXAN, RITUXAN, COMPAZINE, TOPROL, LIPITOR, PRILOSEC, NIACIN. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5399141-4
PENTOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Male patient, weighting 177.5 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: aspiration, chest pain, hypotension, lung infiltration, pneumonia, pseudomonal bacteraemia, renal failure, urine output decreased. PENTOSTATIN dosage: 16 MG. Patient was hospitalized. Patient died on 07/14/2007.

Pentostatin Side Effects Report #5390897-3
Physician from UNITED STATES reported PENTOSTATIN problem on July 05, 2007. Male patient, 69 years of age, weighting 150.0 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: cough, dyspnoea, hypoxia, pleural effusion. PENTOSTATIN dosage: 7.24 MG 3/WK IV. During the same period patient was treated with CYTOXAN, RITUXAN, COMPAZINE, TOPROL, LIPITOR, PRILOSEC, NIACIN. Patient was hospitalized. Patient recovered.


Pentostatin Side Effects Report #5399141-4
PENTOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Male patient, weighting 177.5 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: aspiration, chest pain, hypotension, lung infiltration, pneumonia, pseudomonal bacteraemia, renal failure, urine output decreased. PENTOSTATIN dosage: 16 MG. Patient was hospitalized. Patient died on 07/14/2007.

Pentostatin Side Effects Report #5318570-8
Consumer or non-health professional from UNITED STATES reported PENTOSTATIN problem on May 04, 2007. Female patient, weighting 191.8 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cough, diarrhoea, headache, pulmonary alveolar haemorrhage, pyrexia, respiratory distress, respiratory failure. PENTOSTATIN dosage: 14 MG. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5321929-6
PENTOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on May 08, 2007. Female patient, weighting 191.8 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cough, diarrhoea, headache, pulmonary alveolar haemorrhage, pyrexia, respiratory distress, respiratory failure. PENTOSTATIN dosage: 14 MG. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5331788-3
Physician from UNITED STATES reported PENTOSTATIN problem on May 04, 2007. Female patient, 43 years of age, weighting 191.8 lb, was diagnosed with hodgkin's disease and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, cough, diarrhoea, headache, lung consolidation, pericardial effusion, pleural effusion, pulmonary alveolar haemorrhage, pulmonary oedema. PENTOSTATIN dosage: 14 MG FREQ IV. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5307701-1
PENTOSTATIN problem was reported by a Physician from UNITED STATES on Apr 03, 2007. Male patient, 69 years of age, weighting 151.0 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, pyrexia, transfusion reaction. PENTOSTATIN dosage: 7.24 MG Q3W IV. During the same period patient was treated with CYTOXAN, RITUXAN, COMPAZINE, TOPROL, LIPITOR, PRILOSEC, NIACIN. Patient was hospitalized. Patient recovered.


Pentostatin Side Effects Report #5313389-6
Consumer or non-health professional from UNITED STATES reported PENTOSTATIN problem on Apr 27, 2007. Male patient, weighting 151.2 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: anorexia, diarrhoea, frequent bowel movements, treatment noncompliance. PENTOSTATIN dosage: 7.8 MG. Patient recovered.

Pentostatin Side Effects Report #5313392-6
PENTOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 27, 2007. Male patient, weighting 190.7 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: gun shot wound, head injury, intentional self-injury. PENTOSTATIN dosage: 4 MG. Patient recovered.

Pentostatin Side Effects Report #5313394-X
Consumer or non-health professional from UNITED STATES reported PENTOSTATIN problem on Apr 27, 2007. Male patient, weighting 152.1 lb, was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: anorexia, dehydration, diarrhoea, frequent bowel movements, pneumatosis, refusal of treatment by patient, treatment noncompliance. PENTOSTATIN dosage: 7.8 MG. Patient was hospitalized. Patient recovered.

Pentostatin Side Effects Report #5257144-4
PENTOSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 22, 2007. Male patient, child 9 years of age, weighting 55.12 lb, was diagnosed with graft versus host disease and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: convulsion, diarrhoea, eating disorder, overdose, progressive multifocal leukoencephalopathy, sepsis. PENTOSTATIN dosage: 4 MG/M2 FORTNIGHTLY IV. During the same period patient was treated with KEPPRA, METHADONE, DILAUDID, ATROPINE, FENTANYL, ZOFRAN, ATIVAN, METHYLPHENIDATE. Patient died on 02/20/2007.

Pentostatin Side Effects Report #5270829-9
Pharmacist from UNITED STATES reported PENTOSTATIN problem on Mar 19, 2007. Male patient, weighting 185.0 lb, was diagnosed with chronic lymphocytic leukaemia and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: dialysis, dyspnoea, hypophosphataemia, renal failure, thrombotic microangiopathy. PENTOSTATIN dosage: 8MG X1 IV BOLUS. During the same period patient was treated with CYTOXAN, RITUXAN, PALONOSETRON, COUMADIN, LISINOPRIL, OXYCONTIN, BACTRIM, FAMVIR. Patient was hospitalized. Patient recovered.


Pentostatin Side Effects Report #5288027-1
PENTOSTATIN problem was reported by a Physician from UNITED STATES on Mar 20, 2007. Female patient, child 11 years of age, weighting 52.91 lb, was diagnosed with graft versus host disease and was treated with PENTOSTATIN. After drug was administered, patient experienced the following problems/side effects: ascites, bacterial infection, cholangitis, cholecystitis, hepatic failure, hepatitis, hypotension, lung neoplasm, pancreatitis. PENTOSTATIN dosage: 4 MG/M2 FORTNIGHTLY IV. During the same period patient was treated with VANCOMYCIN, MEROPENEM, OXYCODONE EXTENDED, METRONIDAZOLE ORAL, SULFAMETHOXAZOLE, CEFTAZIDIME, NYSTATIN, BECLOMETHASONE AQUEOUS. Patient was hospitalized. Patient recovered.


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