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Speciafoldine Safety Reports submitted to FDA

Total Speciafoldine reports: 3.
Speciafoldine FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 1.
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Reported Speciafoldine Side Effects: thrombocytopenic purpura, thrombocytopenia, septic shock, pyrexia, pneumococcal sepsis, febrile neutropenia, renal tubular disorder, renal failure acute, localised oedema, blood creatinine increased, subdural haematoma.
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Speciafoldine Side Effects Report #5289674-3
Consumer or non-health professional from reported SPECIAFOLDINE problem on Mar 26, 2007. Female patient, 67 years of age, weighting 154.3 lb, was diagnosed with anaemia, hypertension, atrial flutter, atrial fibrillation, hypothyroidism and was treated with SPECIAFOLDINE. After drug was administered, patient experienced the following problems/side effects: subarachnoid haemorrhage, subdural haematoma. SPECIAFOLDINE dosage: unknown. During the same period patient was treated with LASILIX, CORDARONE, LEVOTHYROXINE, SINTROM, TARDYFERON, RIVOTRIL. Patient recovered.

Speciafoldine Side Effects Report #5050147-4
SPECIAFOLDINE problem was reported by a Pharmacist from FRANCE on Apr 20, 2006. Female patient, 59 years of age, was diagnosed with hypercholesterolaemia, renal transplant and was treated with SPECIAFOLDINE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, localised oedema, renal failure acute, renal tubular disorder. SPECIAFOLDINE dosage: unknown. During the same period patient was treated with FONZYLANE, TAHOR, EZETROL, LASILIX, CELLCEPT, CORTANCYL, PROGRAF, VITAMIN B. Patient was hospitalized. Patient recovered.

Speciafoldine Side Effects Report #5186315-0
Physician from FRANCE reported SPECIAFOLDINE problem on Oct 10, 2006. Female patient, 55 years of age, weighting 174.2 lb, was diagnosed with vitamin supplementation, prophylaxis, non-small cell lung cancer and was treated with SPECIAFOLDINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, pneumococcal sepsis, pyrexia, septic shock, thrombocytopenia, thrombocytopenic purpura. SPECIAFOLDINE dosage: 5 MG, DAILY (1/D). During the same period patient was treated with FOLIC ACID, VITAMIN B, GRANOCYTE, ALIMTA. Patient died on 07/21/2006.


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subarachnoid haemorrhage, subdural haematoma blood creatinine increased, localised oedema, renal failure acute, renal tubular disorder, was diagnosed with anaemia, hypertension, atrial flutter, atrial fibrillation, hypothyroidism and was diagnosed with hypercholesterolaemia, renal transplant and