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Review Infed Safety Reports submitted to FDA

Total Infed reports: 29.
Infed FDA safety alerts: No.
   Reported hospitalizations: 11.
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FDA Reported Infed Side Effects: anaphylactic reaction, dyspnoea, hypotension, chest pain, febrile neutropenia, deep vein thrombosis, anaphylactic shock, pruritus, loss of consciousness, renal failure acute, dysphagia.
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Infed Side Effects Report #5660505-2
Physician from POLAND reported INFED problem on Feb 26, 2008. Female patient, 27 years of age, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, acute respiratory distress syndrome, altered state of consciousness, disseminated intravascular coagulation, hypotension, multi-organ failure, myalgia, pancreatitis. INFED dosage: 100 MG, EVERY SECOND DAY, INTRAVENOUS. During the same period patient was treated with IRON. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5682754-X
INFED problem was reported by a Health Professional from UNITED STATES on Mar 26, 2008. Female patient, 72 years of age, weighting 160.0 lb, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: arthralgia, discomfort. INFED dosage: unknown. Patient recovered.

Infed Side Effects Report #5605620-4
Pharmacist from UNITED STATES reported INFED problem on Jan 23, 2008. Female patient, 19 years of age, weighting 88.00 lb, was diagnosed with iron deficiency anaemia, pregnancy and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: back pain, dyspnoea, infusion related reaction, swelling face. INFED dosage: 900 MG X1 IV DRIP. During the same period patient was treated with DROPERIDOL, REGLAN, HYDROXYZINE, VITAMIN B6. Patient recovered.

Infed Side Effects Report #5512928-X
INFED problem was reported by a Pharmacist from UNITED STATES on Nov 08, 2007. Female patient, 35 years of age, weighting 123.0 lb, was diagnosed with anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: pharyngolaryngeal pain, throat tightness. INFED dosage: 25MG TEST DOSE IV. Patient recovered.


Infed Side Effects Report #5453495-9
Consumer or non-health professional from UNITED STATES reported INFED problem on Sept 05, 2007. Female patient, 29 years of age, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, anxiety, arrhythmia, infusion related reaction. INFED dosage: unknown. Patient recovered.

Infed Side Effects Report #5412239-7
INFED problem was reported by a Health Professional from UNITED STATES on July 31, 2007. Female patient, 58 years of age, was diagnosed with anaemia of malignant disease, testis cancer and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: aspiration, atelectasis, deep vein thrombosis, dysphagia, febrile neutropenia, gastrooesophageal reflux disease, haematocrit decreased, haemoglobin decreased, hiatus hernia. INFED dosage: 400 MG, SINGLE, INTRAVENOUS. During the same period patient was treated with ETOPOSIDE, DARBEPOETIN ALFA, CISPLATIN. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5444597-1
Physician from AZERBAIJAN reported INFED problem on Aug 20, 2007. Female patient was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, loss of consciousness, stillbirth. INFED dosage: unknown. Patient recovered.

Infed Side Effects Report #5460196-X
INFED problem was reported by a Health Professional from UNITED STATES on May 24, 2007. Female patient, 44 years of age, weighting 127.0 lb, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cough, dysphagia, dyspnoea, nausea, pruritus, throat irritation, throat tightness. INFED dosage: 975 MG OVER 1 HOUR, INTRAVENOUS; 25 MG TEST DOSE, INTRAVENOUS. During the same period patient was treated with LEVOTHYROXINE. Patient recovered.

Infed Side Effects Report #5460197-1
Health Professional from UNITED STATES reported INFED problem on July 09, 2007. Female patient, 58 years of age, was diagnosed with anaemia of malignant disease, testis cancer and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, febrile neutropenia, pneumonia. INFED dosage: 400 MG, SINGLE, INTRAVENOUS. During the same period patient was treated with ETOPOSIDE, DARBEPOETIN ALFA, CISPLATIN. Patient was hospitalized. Patient recovered.


Infed Side Effects Report #5397145-9
INFED problem was reported by a Health Professional from UNITED STATES on July 09, 2007. Female patient, 58 years of age, was diagnosed with anaemia of malignant disease, testis cancer and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: chest pain, deep vein thrombosis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, pneumonia, productive cough, renal failure acute. INFED dosage: 400 MG, SINGLE, INTRAVENOUS. During the same period patient was treated with ETOPOSIDE, DARBEPOETIN ALFA, CISPLATIN. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5397145-9
Health Professional from UNITED STATES reported INFED problem on July 09, 2007. Female patient, 58 years of age, was diagnosed with anaemia of malignant disease, testis cancer and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: chest pain, deep vein thrombosis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, pneumonia, productive cough, renal failure acute. INFED dosage: 400 MG, SINGLE, INTRAVENOUS. During the same period patient was treated with ETOPOSIDE, DARBEPOETIN ALFA, CISPLATIN. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5787763-8
INFED problem was reported by a Physician from UNITED STATES on June 24, 2008. Male patient, 65 years of age, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic decreased, depressed level of consciousness, hyperhidrosis, hypoxia, vomiting. INFED dosage: 25 MG TEST DOSE. Patient recovered.

Infed Side Effects Report #5802702-9
Health Professional from UNITED STATES reported INFED problem on May 24, 2007. Female patient, 44 years of age, weighting 127.0 lb, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cough, dysphagia, dyspnoea, nausea, pruritus, throat irritation, throat tightness. INFED dosage: 975 MG OVER 1 HOUR, INTRAVENOUS; 25 MG TEST DOSE, INTRAVENOUS. During the same period patient was treated with LEVOTHYROXINE. Patient recovered.

Infed Side Effects Report #5802703-0
INFED problem was reported by a Health Professional from UNITED STATES on Aug 31, 2007. Female patient, 52 years of age, weighting 100.1 lb, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dysphagia, hypersensitivity, lacrimation increased, lip swelling, rhinorrhoea, sneezing, throat irritation. INFED dosage: 100 MG OVER 1/2 HR IN 100CC NS, INTRAVENOUS. Patient recovered.


Infed Side Effects Report #5802705-4
Health Professional from UNITED STATES reported INFED problem on Aug 31, 2007. Female patient, 46 years of age, weighting 136.9 lb, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, dysphagia, flushing, lip swelling, pharyngeal oedema. INFED dosage: 0.5 ML, SINGLE, TEST DOSE, INTRAVENOUS. Patient recovered.

Infed Side Effects Report #5802712-1
INFED problem was reported by a Health Professional from UNITED STATES on Aug 31, 2007. Female patient, 50 years of age, weighting 140.9 lb, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, dysphagia, lip swelling, throat irritation, throat tightness. INFED dosage: 0.5 ML X 30SEC SINGLE, TEST DOSE, INTRAVENOUS. Patient recovered.

Infed Side Effects Report #5802713-3
Consumer or non-health professional from UNITED STATES reported INFED problem on Sept 05, 2007. Female patient, 29 years of age, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, anxiety, arrhythmia, burning sensation, chest pain, dyspnoea, flushing, palpitations, tachycardia. INFED dosage: unknown. Patient recovered.

Infed Side Effects Report #5802715-7
INFED problem was reported by a Health Professional from UNITED STATES on Sept 17, 2007. Female patient, 82 years of age, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, back pain, feeling hot, hyperhidrosis. INFED dosage: 2-3ML OF 25MG/50ML NS (1-1.5MG) INTRAVENOUS. Patient recovered.

Infed Side Effects Report #5802721-2
Health Professional from UNITED STATES reported INFED problem on Sept 17, 2007. Female patient was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, back pain, chest pain, dyspnoea. INFED dosage: unknown. Patient recovered.


Infed Side Effects Report #5802722-4
INFED problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 18, 2007. Male patient, 65 years of age, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, arrhythmia, chest pain, dizziness, dyspnoea, flushing, hyperhidrosis, nausea, visual disturbance. INFED dosage: unknown. During the same period patient was treated with DIGOXIN, CARDIZEM. Patient recovered.

Infed Side Effects Report #5729768-9
Health Professional from BRAZIL reported INFED problem on Apr 25, 2008. Male patient, 49 years of age, was diagnosed with anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: condition aggravated, hepatic siderosis, hepatitis c. INFED dosage: unknown. During the same period patient was treated with ERYTHROPOIETIN. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5674455-9
INFED problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 18, 2007. Male patient, 65 years of age, was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, arrhythmia, chest pain, dizziness, dyspnoea, flushing, hyperhidrosis, nausea, visual disturbance. INFED dosage: unknown. During the same period patient was treated with DIGOXIN, CARDIZEM. Patient recovered.

Infed Side Effects Report #5372589-X
Health Professional from UNITED STATES reported INFED problem on Aug 15, 2006. Male patient, 73 years of age, weighting 191.8 lb, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction, hypotension, hypoxia, loss of consciousness, pruritus. INFED dosage: 25 MG, TEST DOSE -NOT COMPLETED, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5372606-7
INFED problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 23, 2006. Female patient, 56 years of age, was diagnosed with iron deficiency and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, back pain, chest pain, dyspnoea, flushing, hypertension, tremor, wheezing. INFED dosage: 0.1 MG, SINGLE TEST DOSE, INTRAVENOUS. During the same period patient was treated with PHENERGAN, VALIUM, VICODIN, LOVASTATIN, FOSAMAX. Patient recovered.

Infed Side Effects Report #5372607-9
Health Professional from UNITED STATES reported INFED problem on Jan 17, 2007. Female patient, 70 years of age, was diagnosed with iron deficiency and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cardiac arrest, hypotension. INFED dosage: 2.5 MG, SINGLE TEST DOSE, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5372613-4
INFED problem was reported by a Pharmacist from UNITED STATES on Apr 16, 2007. Female patient, 81 years of age, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. INFED dosage: unknown. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5316942-9
Health Professional from UNITED STATES reported INFED problem on May 01, 2007. Female patient, 39 years of age, weighting 131.0 lb, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea. INFED dosage: 750 MG MONTHLY IV. Patient recovered.

Infed Side Effects Report #5351978-3
INFED problem was reported by a Pharmacist from UNITED STATES on Apr 16, 2007. Female patient, 81 years of age, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. INFED dosage: unknown. Patient was hospitalized. Patient recovered.

Infed Side Effects Report #5293815-1
Health Professional from DENMARK reported INFED problem on Mar 26, 2007. Female patient, 40 years of age, was diagnosed with iron deficiency anaemia and was treated with INFED. After drug was administered, patient experienced the following problems/side effects: exchange blood transfusion, haemodialysis, intravascular haemolysis, renal failure acute. INFED dosage: unknown. During the same period patient was treated with AMLODIPINE, SERTRALINE, SUMATRIPTAN SUCCINATE. Patient was hospitalized. Patient recovered.


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