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Review Hysron Safety Reports submitted to FDA

Total Hysron reports: 9.
Hysron FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 5.
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FDA Reported Hysron Side Effects: pain in extremity, leukopenia, cardiac failure acute, protein total decreased, neutrophil count decreased, blood lactate dehydrogenase increased, blood creatinine increased, aspartate aminotransferase increased, cardiac arrest, acute promyelocytic leukaemia.
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Hysron Side Effects Report #5443931-6
Consumer or non-health professional from JAPAN reported HYSRON problem on Aug 27, 2007. Female patient, weighting 145.5 lb, was diagnosed with breast cancer recurrent and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, cardiac failure acute, leukopenia, pain in extremity. HYSRON dosage: unknown. During the same period patient was treated with VINORELBINE, LOXONIN, OXYCONTIN. Patient was hospitalized. Patient died on 08/23/2007.

Hysron Side Effects Report #5453128-1
HYSRON problem was reported by a Consumer or non-health professional from JAPAN on Sept 04, 2007. Female patient, weighting 145.5 lb, was diagnosed with breast cancer recurrent and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: cardiac failure acute, leukopenia, pain in extremity. HYSRON dosage: DAILY DOSE:800MG-FREQ:DAILY. During the same period patient was treated with VINORELBINE, LOXONIN, OXYCONTIN. Patient was hospitalized. Patient died on 08/23/2007.

Hysron Side Effects Report #5464781-0
Consumer or non-health professional from JAPAN reported HYSRON problem on Sept 13, 2007. Female patient, weighting 145.5 lb, was diagnosed with breast cancer, breast cancer recurrent and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood creatinine increased, blood lactate dehydrogenase increased, cardiac failure acute, leukopenia, neutrophil count decreased, pain in extremity, protein total decreased. HYSRON dosage: DAILY DOSE:800MG-FREQ:DAILY. During the same period patient was treated with ADRIAMYCIN PFS, VINORELBINE, LOXONIN, OXYCONTIN. Patient was hospitalized. Patient died on 08/23/2007.

Hysron Side Effects Report #5470112-2
HYSRON problem was reported by a Consumer or non-health professional from JAPAN on Sept 19, 2007. Female patient, weighting 145.5 lb, was diagnosed with breast cancer, breast cancer recurrent and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: aspartate aminotransferase increased, blood creatinine increased, blood lactate dehydrogenase increased, cardiac failure acute, leukopenia, neutrophil count decreased, pain in extremity, protein total decreased. HYSRON dosage: DAILY DOSE:800MG-FREQ:DAILY. During the same period patient was treated with ADRIAMYCIN PFS, VINORELBINE, LOXONIN, OXYCONTIN. Patient was hospitalized. Patient died on 08/23/2007.


Hysron Side Effects Report #5406569-2
Consumer or non-health professional from JAPAN reported HYSRON problem on July 20, 2007. Female patient, 40 years of age, was diagnosed with breast cancer recurrent and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: acute promyelocytic leukaemia. HYSRON dosage: unknown. During the same period patient was treated with ZOLADEX, TAMOXIFEN CITRATE. Patient was hospitalized. Patient recovered.

Hysron Side Effects Report #5735596-0
HYSRON problem was reported by a Consumer or non-health professional from JAPAN on May 07, 2008. Female patient, 72 years of age, was diagnosed with metastases to bone and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. HYSRON dosage: DAILY DOSE:1200MG-FREQ:DAILY. During the same period patient was treated with AREDIA. Patient recovered.

Hysron Side Effects Report #5745714-6
Consumer or non-health professional from reported HYSRON problem on May 13, 2008. Female patient, 72 years of age, was diagnosed with metastases to bone and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: bone density decreased, osteonecrosis. HYSRON dosage: DAILY DOSE:1200MG-FREQ:DAILY. During the same period patient was treated with AREDIA. Patient recovered.

Hysron Side Effects Report #5749316-7
HYSRON problem was reported by a Consumer or non-health professional from JAPAN on May 13, 2008. Female patient, 72 years of age, was diagnosed with metastases to bone and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: bone density decreased, osteonecrosis. HYSRON dosage: DAILY DOSE:1200MG-FREQ:DAILY. During the same period patient was treated with AREDIA. Patient recovered.

Hysron Side Effects Report #5720376-2
Consumer or non-health professional from JAPAN reported HYSRON problem on Apr 16, 2008. Female patient, 72 years of age, was diagnosed with metastases to bone and was treated with HYSRON. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. HYSRON dosage: DAILY DOSE:1200MG-FREQ:DAILY. During the same period patient was treated with AREDIA. Patient recovered.


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