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Review Exubera Safety Reports submitted to FDA

Total Exubera reports: 211.
Exubera FDA safety alerts: 2008 .
Reported deaths: 24    Reported hospitalizations: 63.
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FDA Reported Exubera Side Effects: blood glucose increased, cough, dyspnoea, hypoglycaemia, blood glucose decreased, device malfunction, haemoptysis, dysgeusia, pain in jaw, chest pain, hyperglycaemia.
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Exubera Side Effects Report #5322920-6
Consumer or non-health professional from UNITED STATES reported EXUBERA problem on Dec 19, 2006. Male patient, 59 years of age, weighting 209.0 lb, was diagnosed with diabetes mellitus insulin-dependent and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, glycosylated haemoglobin increased. EXUBERA dosage: 12 MG (4 MG,3 IN 1 D). During the same period patient was treated with LANTUS, ANTIHYPERTENSIVES. Patient recovered.

Exubera Side Effects Report #5322921-8
EXUBERA problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 22, 2006. Female patient, 39 years of age, weighting 128.0 lb, was diagnosed with diabetes mellitus and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, device malfunction. EXUBERA dosage: unknown. During the same period patient was treated with LIPITOR, LANTUS, ASPIRIN. Patient recovered.

Exubera Side Effects Report #5323696-9
Consumer or non-health professional from UNITED STATES reported EXUBERA problem on Jan 22, 2007. Male patient, 83 years of age, weighting 179.9 lb, was diagnosed with blood glucose and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. EXUBERA dosage: 8 MG (4 MG, 2 IN 1 D). During the same period patient was treated with INSULINS AND ANALOGUES, DIGOXIN, WARFARIN, COREG. Patient recovered.

Exubera Side Effects Report #5323698-2
EXUBERA problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 20, 2006. Male patient, 64 years of age, weighting 198.0 lb, was diagnosed with diabetes mellitus and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. EXUBERA dosage: 15 MG (5 MG, 3 IN 1 D), INHALATION. During the same period patient was treated with ACCUPRIL, ACTONEL, METFORMIN, FUROSEMIDE, CARTIA XT, LANTUS. Patient recovered.


Exubera Side Effects Report #5323715-X
Health Professional from UNITED STATES reported EXUBERA problem on Jan 23, 2007. Male patient, 45 years of age, was diagnosed with diabetes mellitus and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. EXUBERA dosage: unknown. Patient recovered.

Exubera Side Effects Report #5264626-8
EXUBERA problem was reported by a Health Professional from UNITED STATES on Sept 19, 2006. Male patient, 46 years of age, weighting 140.0 lb, was diagnosed with diabetes mellitus insulin-dependent and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: dysgeusia, hyperglycaemia, paraesthesia. EXUBERA dosage: (3 MG), INHALATION. During the same period patient was treated with NOVOLOG, PROGRAF, LIPITOR, MONOPRIL. Patient recovered.

Exubera Side Effects Report #5274428-4
Physician from reported EXUBERA problem on Mar 13, 2007. Male patient, 41 years of age, was diagnosed with diabetes mellitus insulin-dependent and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, fall, hypoglycaemia. EXUBERA dosage: unknown. Patient was hospitalized. Patient died.

Exubera Side Effects Report #5277923-7
EXUBERA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 15, 2007. Male patient, weighting 149.0 lb, was diagnosed with diabetes mellitus, obesity, blood glucose decreased and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, blood glucose increased, convulsion. EXUBERA dosage: DAILY DOSE:5MG. During the same period patient was treated with BYETTA, GLUCOSE, LANTUS, VALSARTAN, SIMVASTATIN, COREG, ACIPHEX. Patient was hospitalized. Patient recovered.

Exubera Side Effects Report #5279567-X
Health Professional from UNITED STATES reported EXUBERA problem on Mar 16, 2007. Female patient, 25 years of age, was diagnosed with diabetes mellitus non-insulin-dependent and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. EXUBERA dosage: unknown. During the same period patient was treated with INSULINS AND ANALOGUES. Patient was hospitalized. Patient recovered.


Exubera Side Effects Report #5282287-9
EXUBERA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 20, 2007. Male patient, weighting 285.1 lb, was diagnosed with diabetes mellitus and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: coronary artery occlusion, oedema peripheral, retinal oedema, visual acuity reduced. EXUBERA dosage: DAILY DOSE:13MG. During the same period patient was treated with SITAGLIPTIN, AVANDIA, ACCUPRIL, PRAVACHOL, GLUCOPHAGE, DIABETA. Patient recovered.

Exubera Side Effects Report #5282288-0
Consumer or non-health professional from UNITED KINGDOM reported EXUBERA problem on Mar 19, 2007. Female patient was diagnosed with diabetes mellitus and was treated with EXUBERA. After drug was administered, patient experienced the following problems/side effects: depressed mood, dysgeusia, ill-defined disorder, pain, pain in jaw. EXUBERA dosage: DAILY DOSE:11MG. During the same period patient was treated with METFORMIN, GLICLAZIDE. Patient recovered.

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