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Review Darbepoetin Safety Reports submitted to FDA

Total Darbepoetin reports: 7.
Darbepoetin FDA safety alerts: 2005 2007 2008 .
Reported deaths: 5    Reported hospitalizations: 8.
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FDA Reported Darbepoetin Side Effects: pain in extremity, myositis, upper respiratory tract infection, pollakiuria, arthralgia, urine amylase increased, respiratory disorder, death, cardiac disorder, blood immunoglobulin g increased, blood amylase increased.
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Darbepoetin Side Effects Report #5477994-9
Physician from UNITED STATES reported DARBEPOETIN problem on Sept 26, 2007. Male patient, weighting 88.18 lb, was diagnosed with renal failure chronic and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: anaemia, anti-erythropoietin antibody positive, urinary tract infection. DARBEPOETIN dosage: unknown. During the same period patient was treated with CALCIUM CARBONATE, SEVELAMER, LEVOCARNITINE, PARICALCITOL, OXYBUTYNIN CHLORIDE, LABETALOL, DOCUSATE, AMLODIPINE. Patient recovered.

Darbepoetin Side Effects Report #5434535-X
DARBEPOETIN problem was reported by a Physician from ITALY on Aug 23, 2007. Female patient, 54 years of age, was diagnosed with renal failure chronic and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: application site erythema, myositis, oedema peripheral, pyrexia, renal failure, swelling face. DARBEPOETIN dosage: unknown. During the same period patient was treated with ASPIRIN, NIFEDIPINE, ILOPROST. Patient was hospitalized. Patient recovered.

Darbepoetin Side Effects Report #5377509-X
Physician from SPAIN reported DARBEPOETIN problem on June 20, 2007. Female patient, 71 years of age, was diagnosed with anaemia of malignant disease and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, blood immunoglobulin g increased, cardiac disorder, respiratory disorder, urine amylase increased. DARBEPOETIN dosage: unknown. During the same period patient was treated with ANTIHYPERTENSIVES, DIGOXIN, ACENOCOUMAROL, MELPHALAN, PREDNISONE, ZOLEDRONIC ACID, BORTEZOMIB, CALCIUM CHLORIDE. Patient died.

Darbepoetin Side Effects Report #5386397-7
DARBEPOETIN problem was reported by a Physician from SPAIN on July 02, 2007. Female patient, 71 years of age, was diagnosed with anaemia of malignant disease and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, blood immunoglobulin g increased, cardiac disorder, respiratory disorder, urine amylase increased. DARBEPOETIN dosage: unknown. During the same period patient was treated with ANTIHYPERTENSIVES, DIGOXIN, ACENOCOUMAROL, MELPHALAN, PREDNISONE, ZOLEDRONIC ACID, BORTEZOMIB, CALCIUM CHLORIDE. Patient died.

Darbepoetin Side Effects Report #5377509-X
Physician from SPAIN reported DARBEPOETIN problem on June 20, 2007. Female patient, 71 years of age, was diagnosed with anaemia of malignant disease and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, blood immunoglobulin g increased, cardiac disorder, respiratory disorder, urine amylase increased. DARBEPOETIN dosage: unknown. During the same period patient was treated with ANTIHYPERTENSIVES, DIGOXIN, ACENOCOUMAROL, MELPHALAN, PREDNISONE, ZOLEDRONIC ACID, BORTEZOMIB, CALCIUM CHLORIDE. Patient died.

Darbepoetin Side Effects Report #5386397-7
DARBEPOETIN problem was reported by a Physician from SPAIN on July 02, 2007. Female patient, 71 years of age, was diagnosed with anaemia of malignant disease and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, blood immunoglobulin g increased, cardiac disorder, respiratory disorder, urine amylase increased. DARBEPOETIN dosage: unknown. During the same period patient was treated with ANTIHYPERTENSIVES, DIGOXIN, ACENOCOUMAROL, MELPHALAN, PREDNISONE, ZOLEDRONIC ACID, BORTEZOMIB, CALCIUM CHLORIDE. Patient died.

Darbepoetin Side Effects Report #5315039-1
Physician from SLOVAKIA (Slovak Republic) reported DARBEPOETIN problem on Apr 26, 2007. Male patient, weighting 132.3 lb, was diagnosed with anaemia of malignant disease and was treated with DARBEPOETIN. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. DARBEPOETIN dosage: unknown. During the same period patient was treated with TRAMADOL, FLUNITRAZEPAM, PENTOXIFYLLINE, LACTULOSE. Patient died on 09/13/2005.


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anaemia, anti-erythropoietin antibody positive, urinary tract infection, application site erythema, myositis, oedema peripheral, pyrexia, renal failure, swelling face, , was diagnosed with renal failure chronic and was diagnosed with renal failure chronic and was diagnosed with anaemia of malignant disease and