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Review Ixabepilone Safety Reports submitted to FDA

Total Ixabepilone reports: 20.
Ixabepilone FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 16.
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FDA Reported Ixabepilone Side Effects: abdominal pain, multi-organ failure, gastrointestinal perforation, tooth abscess, neutropenia, leukopenia, thrombosis, pneumonitis, pleural effusion, malignant neoplasm progression, vomiting.
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Ixabepilone Side Effects Report #5650496-2
Pharmacist from UNITED STATES reported IXABEPILONE problem on Mar 04, 2008. Female patient, 72 years of age, was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: hypotension, laryngospasm, respiratory arrest. IXABEPILONE dosage: 54 MG ONCE IV. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5689201-2
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Mar 27, 2008. Male patient, 76 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: hypomagnesaemia, pneumonia. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5611340-2
Health Professional from ITALY reported IXABEPILONE problem on Jan 31, 2008. Female patient, 40 years of age, was diagnosed with breast cancer and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: dysphonia, leukopenia, neutropenia, thrombocytopenia. IXABEPILONE dosage: unknown. During the same period patient was treated with BEVACIZUMAB. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5625322-8
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Feb 12, 2008. Male patient, 76 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: hypomagnesaemia, pneumonia. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5566336-6
Health Professional from UNITED STATES reported IXABEPILONE problem on Dec 15, 2007. Male patient, 71 years of age, weighting 134.5 lb, was diagnosed with prostate cancer and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: neutropenia. IXABEPILONE dosage: unknown. During the same period patient was treated with MITOXANTRONE, PREDNISONE. Patient recovered.

Ixabepilone Side Effects Report #5573740-9
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Dec 20, 2007. Female patient, 60 years of age, was diagnosed with neoplasm malignant and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: dehydration, neutropenia. IXABEPILONE dosage: unknown. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5509022-0
Health Professional from ITALY reported IXABEPILONE problem on Nov 02, 2007. Female patient, 66 years of age, was diagnosed with breast cancer metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: headache, hypertension, vomiting. IXABEPILONE dosage: unknown. During the same period patient was treated with BEVACIZUMAB, UNIPRIL, LASIX. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5518648-X
IXABEPILONE problem was reported by a Health Professional from ITALY on Nov 07, 2007. Female patient, 66 years of age, was diagnosed with breast cancer metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: headache, hypertension, vomiting. IXABEPILONE dosage: unknown. During the same period patient was treated with BEVACIZUMAB, UNIPRIL, LASIX. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5526623-4
Health Professional from UNITED STATES reported IXABEPILONE problem on Nov 20, 2007. Female patient, 74 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, left ventricular dysfunction. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB, COREG, COUMADIN. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5526806-3
IXABEPILONE problem was reported by a Consumer or non-health professional from GERMANY on Nov 19, 2007. Female patient, 53 years of age, was diagnosed with breast cancer and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: mucosal inflammation, neutropenic sepsis, oesophagitis. IXABEPILONE dosage: unknown. During the same period patient was treated with CAPECITABINE, DOMPERIDONE. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5530883-3
Health Professional from ITALY reported IXABEPILONE problem on Nov 28, 2007. Female patient, 66 years of age, was diagnosed with breast cancer metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: headache, hypertension, vomiting. IXABEPILONE dosage: unknown. During the same period patient was treated with BEVACIZUMAB, UNIPRIL, LASIX, BISOPROLOL FUMARATE. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5531234-0
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Nov 29, 2007. Male patient, 65 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, hypotension, hypoxia, international normalised ratio increased, malignant neoplasm progression, respiratory failure. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB, REGLAN, MEGACE, SENOKOT, MORPHINE, PROCHLORPERAZINE, CEFTAZIDIME. Patient was hospitalized. Patient died on 09/30/2007.

Ixabepilone Side Effects Report #5474675-2
Health Professional from UNITED STATES reported IXABEPILONE problem on Sept 27, 2007. Male patient, 65 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, international normalised ratio increased. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB, REGLAN, MEGACE, SENOKOT. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5479607-9
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Oct 03, 2007. Male patient, 65 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, hypotension, hypoxia, international normalised ratio increased, respiratory failure. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB, REGLAN, MEGACE, SENOKOT. Patient was hospitalized. Patient died on 09/30/2007.

Ixabepilone Side Effects Report #5484070-8
Health Professional from UNITED STATES reported IXABEPILONE problem on Oct 11, 2007. Male patient, 65 years of age, was diagnosed with pancreatic carcinoma metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, hypotension, hypoxia, international normalised ratio increased, respiratory failure. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB, REGLAN, MEGACE, SENOKOT, MORPHINE, PROCHLORPERAZINE, CEFTAZIDIME. Patient was hospitalized. Patient died on 09/30/2007.

Ixabepilone Side Effects Report #5489877-9
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Oct 11, 2007. Male patient, 70 years of age, weighting 238.1 lb, was diagnosed with prostate cancer and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: ventricular extrasystoles. IXABEPILONE dosage: TOTAL DOSE ADMINISTERD IN THIS COURSE-414MG. PATIENT RECEIVED 9 INFUSIONS, 46 MG IV/INFUSION.. During the same period patient was treated with DITROPAN, ROCALTROL. Patient recovered.

Ixabepilone Side Effects Report #5409415-6
Consumer or non-health professional from FRANCE reported IXABEPILONE problem on Aug 08, 2007. Female patient, 54 years of age, was diagnosed with breast cancer metastatic and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: tooth abscess. IXABEPILONE dosage: unknown. During the same period patient was treated with BEVACIZUMAB, LYSANXIA. Patient was hospitalized. Patient recovered.

Ixabepilone Side Effects Report #5424936-8
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on Aug 14, 2007. Female patient, 64 years of age, was diagnosed with pancreatic carcinoma and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, gastrointestinal perforation, multi-organ failure. IXABEPILONE dosage: unknown. During the same period patient was treated with CETUXIMAB. Patient was hospitalized. Patient died on 08/12/2007.

Ixabepilone Side Effects Report #5379884-9
Health Professional from UNITED STATES reported IXABEPILONE problem on July 03, 2007. Male patient, 79 years of age, weighting 183.0 lb, was diagnosed with prostate cancer and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia. IXABEPILONE dosage: unknown. During the same period patient was treated with MITOXANTRONE, PREDNISONE. Patient recovered.

Ixabepilone Side Effects Report #5379884-9
IXABEPILONE problem was reported by a Health Professional from UNITED STATES on July 03, 2007. Male patient, 79 years of age, weighting 183.0 lb, was diagnosed with prostate cancer and was treated with IXABEPILONE. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia. IXABEPILONE dosage: unknown. During the same period patient was treated with MITOXANTRONE, PREDNISONE. Patient recovered.


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