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Review Novomix Safety Reports submitted to FDA

Total Novomix reports: 11.
Novomix FDA safety alerts: No.
Reported deaths: 5    Reported hospitalizations: 4.
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FDA Reported Novomix Side Effects: multi-organ failure, ventricular tachycardia, influenza like illness, hypoglycaemia, vomiting, pneumonia, hypoglycaemic coma, oedema peripheral, hypersensitivity, face oedema, loss of consciousness.
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Novomix Side Effects Report #5672131-X
Physician from CANADA reported NOVOMIX problem on Mar 17, 2008. Female patient, 84 years of age, was diagnosed with type 2 diabetes mellitus and was treated with NOVOMIX. NOVOMIX dosage: unknown. During the same period patient was treated with HYDROMORPHONE, AMITRIPTYLINE, FERROUS GLUCONATE, GLYCON, METOCLOPRAMIDE, METOPROLOL TARTRATE, SENOKOT, GABAPENTIN. Patient was hospitalized. Patient died.

Novomix Side Effects Report #5619854-6
NOVOMIX problem was reported by a Physician from CANADA on Feb 05, 2008. Female patient was diagnosed with type 2 diabetes mellitus and was treated with NOVOMIX. NOVOMIX dosage: unknown. Patient died on 07/25/2007.

Novomix Side Effects Report #5632892-2
Physician from CANADA reported NOVOMIX problem on Feb 14, 2008. Male patient, 64 years of age, weighting 160.0 lb, was diagnosed with type 2 diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: hepatomegaly, jaundice cholestatic, metastatic neoplasm. NOVOMIX dosage: unknown. During the same period patient was treated with CIPROFLOXACIN. Patient was hospitalized. Patient died on 07/25/2007.

Novomix Side Effects Report #5598086-4
NOVOMIX problem was reported by a Physician from CANADA on Jan 14, 2008. Male patient, 80 years of age, weighting 172.0 lb, was diagnosed with insulin-requiring type 2 diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. NOVOMIX dosage: unknown. During the same period patient was treated with GLUCOPHAGE, PERINDOPRIL, DILTIAZEM, SIMVASTATIN, METOPROLOL TARTRATE, CLOPIDOGREL, ALFUZOSIN, ASPIRIN. Patient recovered.

Novomix Side Effects Report #5532938-6
Physician from CANADA reported NOVOMIX problem on Nov 28, 2007. Male patient, 78 years of age, weighting 143.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. NOVOMIX dosage: unknown. During the same period patient was treated with METOPROLOL, ATACAND, ALTACE, LIPITOR, PLAVIX. Patient was hospitalized and became disabled. Patient recovered.

Novomix Side Effects Report #5568334-5
NOVOMIX problem was reported by a Physician from CANADA on Dec 14, 2007. Male patient, 80 years of age, weighting 172.0 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: unresponsive to stimuli. NOVOMIX dosage: unknown. During the same period patient was treated with GLUCOPHAGE, PERINDOPRIL, DILTIAZEM, SIMVASTATIN, METOPROLOL SUCCINATE, CLOPIDOGREL, ALFUZOSIN, ASPIRIN. Patient recovered.

Novomix Side Effects Report #5570552-7
Physician from CANADA reported NOVOMIX problem on Dec 14, 2007. Male patient, 78 years of age, weighting 143.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. NOVOMIX dosage: unknown. During the same period patient was treated with METOPROLOL, ATACAND, ALTACE, LIPITOR, PLAVIX. Patient was hospitalized and became disabled. Patient recovered.

Novomix Side Effects Report #5572909-7
NOVOMIX problem was reported by a Consumer or non-health professional from CANADA on Dec 19, 2007. Female patient, 86 years of age, weighting 108.0 lb, was diagnosed with type 2 diabetes mellitus and was treated with NOVOMIX. NOVOMIX dosage: unknown. Patient died.

Novomix Side Effects Report #5451134-4
Physician from CANADA reported NOVOMIX problem on Sept 04, 2007. Male patient, 54 years of age, weighting 291.0 lb, was diagnosed with diabetes mellitus and was treated with NOVOMIX. NOVOMIX dosage: unknown. During the same period patient was treated with METFORMIN, ASAPHEN, COZAAR, LOZIDE, LIPITOR. Patient died.

Novomix Side Effects Report #5379934-X
NOVOMIX problem was reported by a Physician from CANADA on June 26, 2007. Male patient, 73 years of age, weighting 176.4 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOMIX dosage: unknown. During the same period patient was treated with CRESTOR, QUININE SULPHATE, OMEPRAZOLE, VERAPAMIL, FUROSEMIDE, FOSINOPRIL. Patient recovered.

Novomix Side Effects Report #5379934-X
Physician from CANADA reported NOVOMIX problem on June 26, 2007. Male patient, 73 years of age, weighting 176.4 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with NOVOMIX. After drug was administered, patient experienced the following problems/side effects: hypoglycaemic unconsciousness. NOVOMIX dosage: unknown. During the same period patient was treated with CRESTOR, QUININE SULPHATE, OMEPRAZOLE, VERAPAMIL, FUROSEMIDE, FOSINOPRIL. Patient recovered.


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hepatomegaly, jaundice cholestatic, metastatic neoplasm, hypoglycaemia, cerebrovascular accident, , was diagnosed with type 2 diabetes mellitus and was diagnosed with type 2 diabetes mellitus and was diagnosed with type 2 diabetes mellitus and