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Review Innolet Safety Reports submitted to FDA

Total Innolet reports: 8.
Innolet FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 6.
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FDA Reported Innolet Side Effects: depressed level of consciousness, hypoglycaemia, convulsion, ileus paralytic, abscess, sepsis, enterobacter infection, cardiac arrest, aspiration, hepatic function abnormal, muscle tightness.
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Innolet Side Effects Report #5624178-7
Consumer or non-health professional from JAPAN reported INNOLET problem on Feb 01, 2008. Female patient, 67 years of age, weighting 79.37 lb, was diagnosed with diabetes mellitus, hypertension and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, blood glucose fluctuation, bone pain, confusional state, diarrhoea, loss of consciousness, nephrogenic anaemia. INNOLET dosage: unknown. During the same period patient was treated with INNOLET N CHU, LONGES, LANDEL. Patient was hospitalized. Patient recovered.

Innolet Side Effects Report #5598084-0
INNOLET problem was reported by a Consumer or non-health professional from JAPAN on Jan 11, 2008. Female patient, 67 years of age, weighting 79.37 lb, was diagnosed with diabetes mellitus, hypertension and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: blood glucose fluctuation, bone pain, confusional state, diarrhoea, loss of consciousness, nephrogenic anaemia. INNOLET dosage: unknown. During the same period patient was treated with INNOLET N CHU, LONGES, LANDEL. Patient was hospitalized. Patient recovered.

Innolet Side Effects Report #5443105-9
Physician from JAPAN reported INNOLET problem on Aug 24, 2007. Female patient, 63 years of age, weighting 125.7 lb, was diagnosed with insulin-requiring type ii diabetes mellitus and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal. INNOLET dosage: unknown. During the same period patient was treated with INNOLET N CHU. Patient was hospitalized. Patient recovered.

Innolet Side Effects Report #5452584-2
INNOLET problem was reported by a Physician from JAPAN on Sept 04, 2007. Female patient, 63 years of age, weighting 132.3 lb, was diagnosed with insulin-requiring type ii diabetes mellitus, hypertension, hyperlipidaemia and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, liver disorder. INNOLET dosage: unknown. During the same period patient was treated with INNOLET N CHU, DIOVAN, ASPIRIN, NORVASC, ACTOS, LIPIDIL. Patient was hospitalized. Patient recovered.


Innolet Side Effects Report #5759521-1
Physician from JAPAN reported INNOLET problem on May 26, 2008. Female patient, 67 years of age, weighting 125.7 lb, was diagnosed with insulin-requiring type 2 diabetes mellitus, cerebral infarction and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, cerebral infarction, injection site erythema. INNOLET dosage: unknown. During the same period patient was treated with CRESTOR, ASPIRIN, NORVASC, ACTOS, DIOVAN, METFORMIN. Patient was hospitalized. Patient recovered.

Innolet Side Effects Report #5774844-8
INNOLET problem was reported by a Physician from JAPAN on June 05, 2008. Female patient, 67 years of age, weighting 125.7 lb, was diagnosed with insulin-requiring type 2 diabetes mellitus, cerebral infarction and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, cerebral infarction, injection site erythema. INNOLET dosage: unknown. During the same period patient was treated with CRESTOR, ASPIRIN, NORVASC, ACTOS, DIOVAN, METFORMIN. Patient was hospitalized. Patient recovered.

Innolet Side Effects Report #5729260-1
Physician from JAPAN reported INNOLET problem on Apr 17, 2008. Female patient, weighting 119.0 lb, was diagnosed with type 1 diabetes mellitus and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: amenorrhoea. INNOLET dosage: unknown. During the same period patient was treated with INNOLET N CHU, INNOLET N CHU. Patient recovered.

Innolet Side Effects Report #5711073-8
INNOLET problem was reported by a Physician from JAPAN on Apr 10, 2008. Female patient, weighting 119.0 lb, was diagnosed with type 1 diabetes mellitus and was treated with INNOLET. After drug was administered, patient experienced the following problems/side effects: amenorrhoea. INNOLET dosage: unknown. During the same period patient was treated with INNOLET N CHU, INNOLET N CHU. Patient recovered.


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