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Kardegic Safety Reports submitted to FDA

Total Kardegic reports: 6.
Kardegic FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 4.
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Reported Kardegic Side Effects: stent occlusion, thyroid neoplasm, iodine uptake increased, hyperthyroidism, haemangioma, gastrointestinal tube insertion, dysphagia, cardiomyopathy, blood thyroid stimulating hormone decreased, international normalised ratio increased, hypokalaemia.
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Kardegic Side Effects Report #5243525-1
Consumer or non-health professional from FRANCE reported KARDEGIC problem on Feb 19, 2007. Male patient, 83 years of age, was diagnosed with cardiomyopathy, brain neoplasm, hypertension and was treated with KARDEGIC. After drug was administered, patient experienced the following problems/side effects: blood thyroid stimulating hormone decreased, cardiomyopathy, dysphagia, gastrointestinal tube insertion, haemangioma, hyperthyroidism, iodine uptake increased, thyroid neoplasm. KARDEGIC dosage: unknown. During the same period patient was treated with OMEPRAZOLE, TEMGESIC, MICARDIS, HEMIGOXINE NATIVELLE, NITRODERM, NEO MERCAZOLE. Patient was hospitalized. Patient died on 06/23/2006.

Kardegic Side Effects Report #5247859-6
KARDEGIC problem was reported by a Consumer or non-health professional from FRANCE on Feb 19, 2007. Male patient, 83 years of age, was diagnosed with cardiomyopathy, brain neoplasm, hypertension and was treated with KARDEGIC. After drug was administered, patient experienced the following problems/side effects: blood thyroid stimulating hormone decreased, cardiomyopathy, dysphagia, gastrointestinal tube insertion, haemangioma, hyperthyroidism, iodine uptake increased, thyroid neoplasm. KARDEGIC dosage: unknown. During the same period patient was treated with OMEPRAZOLE, TEMGESIC, MICARDIS, HEMIGOXINE NATIVELLE, NITRODERM, NEO MERCAZOLE. Patient was hospitalized. Patient died on 06/23/2006.

Kardegic Side Effects Report #5274173-5
Health Professional from FRANCE reported KARDEGIC problem on Mar 13, 2007. Male patient, 81 years of age, was diagnosed with myocardial infarction and was treated with KARDEGIC. After drug was administered, patient experienced the following problems/side effects: stent occlusion. KARDEGIC dosage: unknown. During the same period patient was treated with PLAVIX. Patient died on 01/06/2006.

Kardegic Side Effects Report #5274176-0
KARDEGIC problem was reported by a Health Professional from FRANCE on Mar 13, 2007. Female patient, 65 years of age, was diagnosed with stent placement, hypertension, dyslipidaemia and was treated with KARDEGIC. After drug was administered, patient experienced the following problems/side effects: stent occlusion. KARDEGIC dosage: unknown. During the same period patient was treated with TRIATEC, LASIX, CRESTOR, CARDENSIEL, PLAVIX. Patient recovered.

Kardegic Side Effects Report #5290526-3
Health Professional from FRANCE reported KARDEGIC problem on Mar 30, 2007. Male patient, 53 years of age, was diagnosed with ill-defined disorder and was treated with KARDEGIC. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, angina unstable. KARDEGIC dosage: unknown. During the same period patient was treated with PERINDOPRIL ERBUMINE, TAHOR, PLAVIX, CARDENSIEL. Patient was hospitalized. Patient recovered.

Kardegic Side Effects Report #5456350-3
KARDEGIC problem was reported by a Consumer or non-health professional from FRANCE on Sept 13, 2007. Male patient, 77 years of age, was diagnosed with atrial fibrillation and was treated with KARDEGIC. After drug was administered, patient experienced the following problems/side effects: anaemia, chest pain, fall, haemoglobin decreased, hypokalaemia, international normalised ratio increased. KARDEGIC dosage: 75 MG, QD. During the same period patient was treated with ZOCOR, PLAVIX, AMLOR, VASTAREL, NEXIUM, COTAREG, PREVISCAN. Patient was hospitalized. Patient recovered.


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blood thyroid stimulating hormone decreased, cardiomyopathy, dysphagia, gastrointestinal tube insertion, haemangioma, hyperthyroidism, iodine uptake increased, thyroid neoplasm, was diagnosed with cardiomyopathy, brain neoplasm, hypertension and was diagnosed with cardiomyopathy, brain neoplasm, hypertension and