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Review Norpace Safety Reports submitted to FDA

Total Norpace reports: 4.
Norpace FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Norpace Side Effects: pneumonia aspiration, hypoglycaemia, bradycardia, arrhythmia, palpitations, vertigo, dizziness.
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Norpace Side Effects Report #5476318-0
Physician from UNITED STATES reported NORPACE problem on Feb 22, 2007. Male patient, 73 years of age, was treated with NORPACE. After drug was administered, patient experienced the following problems/side effects: palpitations. NORPACE dosage: 1050 MG (150 MG, 7 IN 1 D). Patient recovered.

Norpace Side Effects Report #5476919-X
NORPACE problem was reported by a Pharmacist from UNITED STATES on Jan 10, 2007. Male patient, 73 years of age, was treated with NORPACE. After drug was administered, patient experienced the following problems/side effects: arrhythmia. NORPACE dosage: 1050 MG (150 MG, 7 IN 1 D). Patient recovered.

Norpace Side Effects Report #5356243-6
Physician from JAPAN reported NORPACE problem on June 01, 2007. Female patient, weighting 92.15 lb, was diagnosed with arrhythmia, atrial fibrillation, thrombosis prophylaxis, cardiac failure chronic, bronchitis chronic, pneumonia, gastritis and was treated with NORPACE. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypoglycaemia, pneumonia aspiration. NORPACE dosage: unknown. During the same period patient was treated with WARFARIN, DIGOSIN, ERYTHROMYCIN STEARATE, FOSFOMYCIN, CEFAZOLIN, AZULENE, GLUTAMINE. Patient was hospitalized and became disabled. Patient recovered.

Norpace Side Effects Report #5362683-1
NORPACE problem was reported by a Physician from JAPAN on June 07, 2007. Female patient, weighting 92.15 lb, was diagnosed with arrhythmia, atrial fibrillation, thrombosis prophylaxis, cardiac failure chronic, bronchitis chronic, pneumonia, gastritis and was treated with NORPACE. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypoglycaemia, pneumonia aspiration. NORPACE dosage: unknown. During the same period patient was treated with WARFARIN, DIGOSIN, ERYTHROMYCIN STEARATE, FOSFOMYCIN, CEFAZOLIN, AZULENE, GLUTAMINE. Patient was hospitalized and became disabled. Patient recovered.


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palpitations, arrhythmia, bradycardia, hypoglycaemia, pneumonia aspiration, bradycardia, hypoglycaemia, pneumonia aspiration, , was diagnosed with arrhythmia, atrial fibrillation, thrombosis prophylaxis, cardiac failure chronic, bronchitis chronic, pneumonia, gastritis and