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Review Trangorex Safety Reports submitted to FDA

Total Trangorex reports: 11.
Trangorex FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 5.
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FDA Reported Trangorex Side Effects: subarachnoid haemorrhage, international normalised ratio increased, cerebellar haemorrhage, nodal rhythm, bradycardia, acute pulmonary oedema, torsade de pointes, syncope, vomiting, renal failure acute, malaise.
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Trangorex Side Effects Report #5664355-2
Health Professional from FRANCE reported TRANGOREX problem on Mar 03, 2008. Female patient, 78 years of age, was diagnosed with atrial fibrillation and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: mental impairment, parkinsonism, vomiting. TRANGOREX dosage: unknown. Patient recovered.

Trangorex Side Effects Report #5621827-4
TRANGOREX problem was reported by a Health Professional from FRANCE on Jan 30, 2008. Female patient, 63 years of age, was diagnosed with atrial fibrillation, renal failure chronic, prophylaxis against gastrointestinal ulcer and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased, pericardial haemorrhage. TRANGOREX dosage: unknown. During the same period patient was treated with ACFOL, RENAGEL, LORAMET, SINTROM, OMEPRAZOLE. Patient recovered.

Trangorex Side Effects Report #5584302-1
Health Professional from FRANCE reported TRANGOREX problem on Dec 27, 2007. Female patient, 84 years of age, was diagnosed with acute coronary syndrome, myocardial ischaemia and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: anaemia haemolytic autoimmune. TRANGOREX dosage: unknown. During the same period patient was treated with SOLINITRINA, ACETYLSALICYLIC ACID SRT, SEGURIL, ATORVASTATIN CALCIUM, PLAVIX, NITRO. Patient was hospitalized. Patient recovered.

Trangorex Side Effects Report #5604089-3
TRANGOREX problem was reported by a Health Professional from FRANCE on Jan 16, 2008. Male patient, 61 years of age, was diagnosed with atrial fibrillation, sepsis and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: bradycardia, electrocardiogram qt prolonged, torsade de pointes. TRANGOREX dosage: unknown. During the same period patient was treated with NOREPINEPHRINE, CEFTRIAXONE, TAVANIC. Patient was hospitalized. Patient recovered.


Trangorex Side Effects Report #5555019-4
Health Professional from FRANCE reported TRANGOREX problem on Dec 04, 2007. Male patient, 84 years of age, was diagnosed with atrial fibrillation, gastritis prophylaxis, depression, renal hypertension, acute myocardial infarction and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: bradycardia, hyperkalaemia, renal failure acute. TRANGOREX dosage: unknown. During the same period patient was treated with PRAVASTATIN, OMEPRAZOLE, PROZAC, ENALAPRIL, ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.

Trangorex Side Effects Report #5510297-2
TRANGOREX problem was reported by a Health Professional from FRANCE on Nov 02, 2007. Female patient, 78 years of age, was diagnosed with atrial fibrillation, hypocalcaemia, hypothyroidism, renal transplant, hyperlipidaemia and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: cerebral haematoma. TRANGOREX dosage: unknown. During the same period patient was treated with CALCITRIOL, LEVOTHROID, SANDIMMUNE, ACENOCOUMAROL, SIMVASTATIN. Patient was hospitalized. Patient recovered.

Trangorex Side Effects Report #5511593-5
Health Professional from FRANCE reported TRANGOREX problem on Oct 31, 2007. Male patient, 74 years of age, was diagnosed with atrial fibrillation, depression, ischaemic cardiomyopathy, hyperlipidaemia and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, pulmonary oedema. TRANGOREX dosage: unknown. During the same period patient was treated with SERTRALINE, ADIRO, SIMVASTATIN, LORAZEPAM, NOVOMIX, NOVORAPID, ENALAPRIL MALEATE, UNIKET. Patient died.

Trangorex Side Effects Report #5515811-9
TRANGOREX problem was reported by a Health Professional from FRANCE on Nov 12, 2007. Male patient, 74 years of age, was diagnosed with atrial fibrillation, depression, ischaemic cardiomyopathy, hyperlipidaemia and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, pulmonary oedema. TRANGOREX dosage: unknown. During the same period patient was treated with SERTRALINE, ADIRO, SIMVASTATIN, LORAZEPAM, NOVOMIX, NOVORAPID, ENALAPRIL MALEATE, UNIKET. Patient died on 05/10/2007.

Trangorex Side Effects Report #5520339-6
Health Professional from FRANCE reported TRANGOREX problem on Nov 12, 2007. Female patient, 61 years of age, was diagnosed with atrial fibrillation, renal hypertension, thrombosis prophylaxis and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: haematuria. TRANGOREX dosage: unknown. During the same period patient was treated with ATENOLOL, SINTROM. Patient was hospitalized. Patient recovered.


Trangorex Side Effects Report #5521598-6
TRANGOREX problem was reported by a Health Professional from FRANCE on Nov 13, 2007. Male patient, 74 years of age, was diagnosed with atrial fibrillation, depression, ischaemic cardiomyopathy, hyperlipidaemia and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage, pulmonary oedema. TRANGOREX dosage: unknown. During the same period patient was treated with SERTRALINE, ADIRO, SIMVASTATIN, LORAZEPAM, NOVOLOG, NOVORAPID, ENALAPRIL MALEATE, UNIKET. Patient died on 05/10/2007.

Trangorex Side Effects Report #5697928-1
Health Professional from FRANCE reported TRANGOREX problem on Mar 27, 2008. Female patient, 66 years of age, was diagnosed with atrial fibrillation and was treated with TRANGOREX. After drug was administered, patient experienced the following problems/side effects: pain in extremity. TRANGOREX dosage: unknown. During the same period patient was treated with SINTROM. Patient recovered.


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