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Review Vinflunine Safety Reports submitted to FDA

Total Vinflunine reports: 4.
Vinflunine FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Vinflunine Side Effects: urosepsis, febrile neutropenia, white blood cell count decreased, platelet count decreased, oral intake reduced, dehydration, staphylococcal infection, small intestinal obstruction, myalgia, back pain, stomatitis.
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Vinflunine Side Effects Report #5676133-9
Health Professional from FRANCE reported VINFLUNINE problem on Mar 11, 2008. Female patient, 64 years of age, was diagnosed with breast cancer metastatic and was treated with VINFLUNINE. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy. VINFLUNINE dosage: unknown. During the same period patient was treated with DOXORUBICIN, ATACAND, BRUFEN, TOREM. Patient recovered.

Vinflunine Side Effects Report #5593394-5
VINFLUNINE problem was reported by a Health Professional from UNITED STATES on Jan 10, 2008. Female patient, 72 years of age, weighting 165.3 lb, was diagnosed with non-small cell lung cancer, prophylaxis and was treated with VINFLUNINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bone marrow failure, constipation, headache, ileus paralytic, nausea, vomiting. VINFLUNINE dosage: EXPIRY DATE FOR LOT NUMBER 7C33262- 31MAR2009. VINFLUNINE 320MG/M2. During the same period patient was treated with CETUXIMAB, LEVOXYL, CALCIUM GLUCONATE, COUMADIN, ASPIRIN, VICODIN, VITAMIN, ALEVE. Patient was hospitalized. Patient recovered.

Vinflunine Side Effects Report #5526628-3
Health Professional from UNITED STATES reported VINFLUNINE problem on Nov 20, 2007. Female patient, 72 years of age, weighting 165.3 lb, was diagnosed with non-small cell lung cancer, prophylaxis and was treated with VINFLUNINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bone marrow failure, constipation, headache, ileus paralytic, nausea, vomiting. VINFLUNINE dosage: EXPIRY DATE FOR LOT NUMBER 7C33262- 31MAR2009. VINFLUNINE 320MG/M2. During the same period patient was treated with CETUXIMAB, LEVOXYL, CALCIUM, COUMADIN, ASPIRIN, VICODIN, VITAMIN, ALEVE. Patient was hospitalized. Patient recovered.

Vinflunine Side Effects Report #5530686-X
VINFLUNINE problem was reported by a Health Professional from UNITED STATES on Nov 28, 2007. Female patient, weighting 164.5 lb, was diagnosed with lung neoplasm malignant, metastases to bone and was treated with VINFLUNINE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, bone pain, dehydration, diarrhoea, headache, ileus paralytic. VINFLUNINE dosage: 595 MG Q3WKS IV. During the same period patient was treated with LEVOXYL, COUMADIN, VICODIN, VITAMIN, CALCIUM, ASPIRIN. Patient was hospitalized. Patient recovered.


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cardiomyopathy, abdominal pain, bone marrow failure, constipation, headache, ileus paralytic, nausea, vomiting, , was diagnosed with breast cancer metastatic and was diagnosed with non-small cell lung cancer, prophylaxis and