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Hexabrix Safety Reports submitted to FDA

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Total Hexabrix reports: 26.
Hexabrix FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 8.
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FDA Reported Hexabrix Side Effects: hypotension, bradycardia, hypersensitivity, dyspnoea, pruritus, sneezing, anaphylactic shock, lacrimation increased, eyelid oedema, cough, cyanosis.
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Hexabrix Side Effects Report #5244846-9
Health Professional from FRANCE reported HEXABRIX problem on Feb 02, 2007. Male patient, 50 years of age, was diagnosed with angiogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: arteriospasm coronary, hypoaesthesia, nausea, pruritus, rash, shock, vomiting. HEXABRIX dosage: 10 ML, SINGLE, INTRA-ARTERIAL. Patient was hospitalized. Patient recovered.

Hexabrix Side Effects Report #5295512-5
HEXABRIX problem was reported by a Health Professional from FRANCE on Mar 22, 2007. Male patient, 61 years of age, weighting 209.4 lb, was diagnosed with arteriogram coronary and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bradycardia, bronchospasm, face oedema, hypotension. HEXABRIX dosage: 50 ML, SINGLE, INTRA-ARTERIAL. Patient recovered.

Hexabrix Side Effects Report #5295513-7
Health Professional from FRANCE reported HEXABRIX problem on Mar 22, 2007. Male patient was diagnosed with cardiovascular evaluation and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. HEXABRIX dosage: 100 ML, SINGLE, UNK. Patient recovered.

Hexabrix Side Effects Report #5295514-9
HEXABRIX problem was reported by a Health Professional from FRANCE on Mar 22, 2007. Male patient was diagnosed with cardiovascular evaluation and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. HEXABRIX dosage: 100 ML, SINGLE, UNK. Patient recovered.

Hexabrix Side Effects Report #5314698-7
Health Professional from FRANCE reported HEXABRIX problem on Apr 12, 2007. Male patient, 61 years of age, weighting 209.4 lb, was diagnosed with arteriogram coronary and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bradycardia, bronchospasm, face oedema, hypotension. HEXABRIX dosage: 50 ML, SINGLE, INTRA-ARTERIAL. Patient recovered.

Hexabrix Side Effects Report #5320896-9
HEXABRIX problem was reported by a Health Professional from FRANCE on Apr 20, 2007. Female patient, 31 years of age, weighting 121.3 lb, was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bradycardia, cyanosis, dyspnoea, erythema, hypotension, pain, pruritus. HEXABRIX dosage: 20 ML SINGLE INTRA-ARTICULAR. During the same period patient was treated with DESLORATADINE, CELESTONE. Patient was hospitalized. Patient recovered.

Hexabrix Side Effects Report #5050627-1
Health Professional from JAPAN reported HEXABRIX problem on June 29, 2006. Female patient, 30 years of age, was diagnosed with angiogram cerebral and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, contrast media reaction, dysphoria, loss of consciousness. HEXABRIX dosage: 2 ML SINGLE INTRA-ARTERIAL. During the same period patient was treated with WARFARIN, ASPIRIN, SENNOSIDE A. Patient recovered.

Hexabrix Side Effects Report #5060268-8
HEXABRIX problem was reported by a Health Professional from FRANCE on July 11, 2006. Male patient, 64 years of age, was diagnosed with catheterisation cardiac and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, incontinence, shock. HEXABRIX dosage: 10 ML, SINGLE. Patient recovered.

Hexabrix Side Effects Report #5074218-1
Health Professional from SWITZERLAND reported HEXABRIX problem on July 25, 2006. Female patient, 43 years of age, weighting 196.2 lb, was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bradycardia, cough, dyspnoea, eyelid oedema, hypotension, lacrimation increased, pruritus, sneezing, vomiting. HEXABRIX dosage: 3 ML, SINGLE, INTRA-ARTICULAR. During the same period patient was treated with ARTIREM, TAVEGYL, ZANTIC. Patient was hospitalized. Patient recovered.

Hexabrix Side Effects Report #5084312-7
HEXABRIX problem was reported by a Health Professional from UNITED STATES on Aug 03, 2006. Male patient, 55 years of age, was diagnosed with catheterisation cardiac and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, hypotension, respiratory failure. HEXABRIX dosage: 85 ML SINGLE. During the same period patient was treated with NEOSYNEPHRINE, LEVOPHED. Patient was hospitalized and became disabled. Patient recovered.

Hexabrix Side Effects Report #5103018-9
Consumer or non-health professional from FRANCE reported HEXABRIX problem on Aug 28, 2006. Female patient, 43 years of age, weighting 196.2 lb, was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bradycardia, cough, dyspnoea, eyelid oedema, hypotension, lacrimation increased, pruritus, rash, sneezing. HEXABRIX dosage: 3 ML, SINGLE, INTRA-ARTICULAR. During the same period patient was treated with ARTIREM, TAVEGYL, ZANTIC. Patient was hospitalized. Patient recovered.

Hexabrix Side Effects Report #5110883-8
HEXABRIX problem was reported by a Consumer or non-health professional from SWITZERLAND on Sept 08, 2006. Female patient, 43 years of age, weighting 196.2 lb, was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bradycardia, cough, dyspnoea, eyelid oedema, hypotension, lacrimation increased, pruritus, rash, sneezing. HEXABRIX dosage: 3 ML, SINGLE, INTRA-ARTICULAR. During the same period patient was treated with ARTIREM, TAVEGYL, ZANTIC. Patient was hospitalized. Patient recovered.

Hexabrix Side Effects Report #5115414-4
Consumer or non-health professional from FRANCE reported HEXABRIX problem on Sept 08, 2006. Male patient, 55 years of age, weighting 187.4 lb, was diagnosed with cardiac monitoring and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, bradycardia, electrocardiogram st segment depression, electrocardiogram st segment elevation, myocardial ischaemia, urinary incontinence. HEXABRIX dosage: 10 ML, SINGLE, INTRA-ARTERIAL. During the same period patient was treated with ISOSORBIDE DINITRATE, ASPIRIN, ALLOPURINOL, ZANTAC, ISOSORBIDE DINITRATE, LIVALO, CARVEDILOL, TICLOPIDINE. Patient recovered.

Hexabrix Side Effects Report #5134209-9
HEXABRIX problem was reported by a Health Professional from FRANCE on Oct 04, 2006. Male patient was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: arthralgia, c-reactive protein increased, gait disturbance, synovitis. HEXABRIX dosage: unknown. Patient recovered.

Hexabrix Side Effects Report #5134210-5
Health Professional from JAPAN reported HEXABRIX problem on Oct 04, 2006. Male patient, child 6 years of age, was diagnosed with angiogram, anaesthesia and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. HEXABRIX dosage: unknown. During the same period patient was treated with THIOPENTAL, VECURONIUM BROMIDE, FENTANYL CITRATE, SEVOFLURANE INHALATION GAS. Patient recovered.

Hexabrix Side Effects Report #5152607-4
HEXABRIX problem was reported by a Health Professional from JAPAN on Oct 25, 2006. Male patient, child 6 years of age, was diagnosed with angiogram, anaesthesia and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, bradycardia, hypersensitivity, oxygen saturation decreased, procedural complication. HEXABRIX dosage: 10 ML, SINGLE, INTRAVENOUS. During the same period patient was treated with THIOPENTAL, VECURONIUM BROMIDE, FENTANYL CITRATE, SEVOFLURANE. Patient recovered.

Hexabrix Side Effects Report #5164844-3
Health Professional from FRANCE reported HEXABRIX problem on Nov 10, 2006. Male patient, 70 years of age, weighting 176.4 lb, was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: arthralgia, arthritis, condition aggravated, gait disturbance, mobility decreased, myositis, synovitis. HEXABRIX dosage: unknown. During the same period patient was treated with XYLOCAINE. Patient was hospitalized and became disabled. Patient recovered.

Hexabrix Side Effects Report #5189532-9
HEXABRIX problem was reported by a Health Professional from FRANCE on Dec 01, 2006. Female patient, 25 years of age, was diagnosed with arthrogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: cyanosis, dyspnoea, erythema, pain. HEXABRIX dosage: unknown. Patient was hospitalized. Patient recovered.

Hexabrix Side Effects Report #5397500-7
Health Professional from FRANCE reported HEXABRIX problem on July 17, 2007. Male patient, 76 years of age, was diagnosed with arteriogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: bronchospasm, cardiogenic shock, cyanosis, face oedema, oedema mucosal, respiratory arrest, urticaria. HEXABRIX dosage: 187 ML, SINGLE. During the same period patient was treated with FORADIL, QVAR, ATARAX, HYPOSTAMINE. Patient recovered.

Hexabrix Side Effects Report #5397501-9
HEXABRIX problem was reported by a Health Professional from FRANCE on July 17, 2007. Female patient was diagnosed with stent placement and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: renal failure. HEXABRIX dosage: 50 ML, SINGLE. During the same period patient was treated with LASIX, KARDEGIC, ATACAND. Patient died on 05/14/2007.

Hexabrix Side Effects Report #5408403-3
Health Professional from FRANCE reported HEXABRIX problem on July 26, 2007. Female patient was diagnosed with spinal myelogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: convulsion, off label use. HEXABRIX dosage: unknown. Patient recovered.

Hexabrix Side Effects Report #5413784-0
HEXABRIX problem was reported by a Health Professional from FRANCE on Aug 02, 2007. Female patient was diagnosed with arteriogram coronary and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, chest pain, peripheral ischaemia. HEXABRIX dosage: unknown. Patient recovered.

Hexabrix Side Effects Report #5416573-6
Health Professional from FRANCE reported HEXABRIX problem on Aug 09, 2007. Female patient was diagnosed with spinal myelogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: convulsion, off label use. HEXABRIX dosage: unknown. Patient recovered.

Hexabrix Side Effects Report #5463020-4
HEXABRIX problem was reported by a Health Professional from FRANCE on Sept 13, 2007. Female patient was diagnosed with stent placement, coronary angioplasty, cardiac failure and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: renal failure. HEXABRIX dosage: 50 ML, SINGLE. During the same period patient was treated with LASIX, KARDEGIC, ATACAND. Patient died on 05/14/2007.

Hexabrix Side Effects Report #5464085-6
Health Professional from FRANCE reported HEXABRIX problem on Sept 13, 2007. Female patient was diagnosed with cardiovascular evaluation and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: crepitations, hypersensitivity, urticaria. HEXABRIX dosage: 100 ML, SINGLE. Patient recovered.

Hexabrix Side Effects Report #5464094-7
HEXABRIX problem was reported by a Health Professional from FRANCE on Sept 13, 2007. Female patient was diagnosed with cardiovascular evaluation and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, hypotension, sneezing. HEXABRIX dosage: 100 ML, SINGLE. Patient recovered.

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