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Amicar Safety Reports submitted to FDA

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Total Amicar reports: 3.
Amicar FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Amicar Side Effects: nausea, troponin increased, electrocardiogram t wave inversion, angina unstable, post procedural complication, electrocardiogram st segment elevation, cardiovascular disorder, syncope, incorrect dose administered, head injury, gastrointestinal haemorrhage.
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Amicar Side Effects Report #5201379-3
Health Professional from UNITED STATES reported AMICAR problem on Jan 02, 2007. Female patient, 68 years of age, was diagnosed with hypertriglyceridaemia and was treated with AMICAR. After drug was administered, patient experienced the following problems/side effects: angina unstable, chest pain, electrocardiogram t wave inversion, nausea, troponin increased. AMICAR dosage: unknown. During the same period patient was treated with OMACOR. Patient was hospitalized. Patient recovered.

Amicar Side Effects Report #5113755-8
AMICAR problem was reported by a Pharmacist from UNITED STATES on Sept 21, 2006. Female patient, weighting 104.0 lb, was diagnosed with haemorrhage and was treated with AMICAR. After drug was administered, patient experienced the following problems/side effects: dizziness, fall, gastrointestinal haemorrhage, head injury, incorrect dose administered, nausea, syncope. AMICAR dosage: unknown. During the same period patient was treated with APAP, CALCIUM CARBONATE, LANSOPRAZOLE, TEMAZEPAM. Patient was hospitalized. Patient recovered.

Amicar Side Effects Report #5135779-7
Pharmacist from UNITED STATES reported AMICAR problem on Oct 24, 2006. Female patient, 68 years of age, weighting 143.3 lb, was diagnosed with hypertriglyceridaemia and was treated with AMICAR. After drug was administered, patient experienced the following problems/side effects: angina unstable, cardiovascular disorder, electrocardiogram st segment elevation, electrocardiogram t wave inversion, nausea, post procedural complication, troponin increased. AMICAR dosage: 1 GRAM DOSE -TWO 500MG TABS- TID PO. During the same period patient was treated with OMEGA. Patient was hospitalized. Patient recovered.


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angina unstable, chest pain, electrocardiogram t wave inversion, nausea, troponin increased dizziness, fall, gastrointestinal haemorrhage, head injury, incorrect dose administered, nausea, syncope, was diagnosed with hypertriglyceridaemia and was diagnosed with haemorrhage and was diagnosed with hypertriglyceridaemia and