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Review Phosblock Safety Reports submitted to FDA

Total Phosblock reports: 3.
Phosblock FDA safety alerts: No.
Reported deaths: 2    .
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FDA Reported Phosblock Side Effects: diarrhoea, gastrointestinal haemorrhage, gastritis erosive, ileus paralytic, nausea, haemoglobin decreased, enteritis, diverticulum intestinal haemorrhagic, diverticulitis, blood phosphorus increased, malaise.
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Phosblock Side Effects Report #5538453-8
Physician from JAPAN reported PHOSBLOCK problem on Nov 21, 2007. Male patient, 55 years of age, was diagnosed with hyperphosphataemia and was treated with PHOSBLOCK. After drug was administered, patient experienced the following problems/side effects: anorexia, blood alkaline phosphatase increased, condition aggravated, diabetes mellitus, diabetic nephropathy. PHOSBLOCK dosage: unknown. During the same period patient was treated with PRECIPIATED CALCIUM CARBONATE, ASPIRIN, CANDESARTAN CILEXETIL, FAMOTIDINE, TICLOPIDINE HYDROCHLORIDE, AMLODIPINE BESYLATE. Patient died on 07/07/2006.

Phosblock Side Effects Report #5528402-0
PHOSBLOCK problem was reported by a Physician from JAPAN on Nov 09, 2007. Female patient, 69 years of age, was diagnosed with hyperphosphataemia and was treated with PHOSBLOCK. After drug was administered, patient experienced the following problems/side effects: blood thyroid stimulating hormone increased. PHOSBLOCK dosage: unknown. During the same period patient was treated with CALTAN, EVISTA, ASPIRIN, THYRADIN. Patient recovered.

Phosblock Side Effects Report #5466096-3
Physician from JAPAN reported PHOSBLOCK problem on Sept 05, 2007. Male patient, 55 years of age, was diagnosed with hyperphosphataemia and was treated with PHOSBLOCK. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, oral intake reduced. PHOSBLOCK dosage: 250 MG QD PO. During the same period patient was treated with PRECIPIATED CALCIUM CARBONATE, ASPIRIN, CANDESARTAN CILEXETIL, FAMOTIDINE, TICLOPIDINE HYDROCHLORIDE, AMLODIPINE BESYLATE. Patient died on 07/07/2006.


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