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Novalgin Safety Reports submitted to FDA

Total Novalgin reports: 4.
Novalgin FDA safety alerts: No.
   Reported hospitalizations: 2.
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Reported Novalgin Side Effects: agranulocytosis, neutropenia, haemorrhage, cellulitis, aphthous stomatitis, musculoskeletal stiffness, borrelia burgdorferi serology positive, blood pressure fluctuation, eosinophilia, depression, deep vein thrombosis.
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Novalgin Side Effects Report #5042727-7
Health Professional from GERMANY reported NOVALGIN problem on June 01, 2006. Female patient, 74 years of age, weighting 165.3 lb, was diagnosed with pain, deep vein thrombosis, hypertension, osteoporosis and was treated with NOVALGIN. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, aphthous stomatitis, cellulitis, haemorrhage, leukopenia, neutropenia, pyrexia, thrombocytopenia. NOVALGIN dosage: unknown. During the same period patient was treated with CLEXANE, DELIX PLUS, VIGANTOLETTEN, CALCIUM GLUCONATE, OXYGESIC. Patient was hospitalized. Patient recovered.

Novalgin Side Effects Report #5072051-8
NOVALGIN problem was reported by a Pharmacist from GERMANY on July 24, 2006. Female patient, weighting 149.9 lb, was treated with NOVALGIN. After drug was administered, patient experienced the following problems/side effects: agranulocytosis. NOVALGIN dosage: unknown. During the same period patient was treated with VOLTAREN. Patient recovered.

Novalgin Side Effects Report #5085384-6
Health Professional from GERMANY reported NOVALGIN problem on June 01, 2006. Female patient, 74 years of age, weighting 165.3 lb, was diagnosed with pain, deep vein thrombosis, hypertension, osteoporosis, pulmonary embolism and was treated with NOVALGIN. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, aphthous stomatitis, cellulitis, deep vein thrombosis, depression, eosinophilia, haemorrhage, neutropenia. NOVALGIN dosage: unknown. During the same period patient was treated with CLEXANE, DELIX PLUS, VIGANTOLETTEN, CALCIUM GLUCONATE, OXYGESIC, MARCUMAR. Patient was hospitalized. Patient recovered.

Novalgin Side Effects Report #5409269-8
NOVALGIN problem was reported by a Health Professional from GERMANY on Aug 06, 2007. Female patient, 49 years of age, was diagnosed with hypertension and was treated with NOVALGIN. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, borrelia burgdorferi serology positive, musculoskeletal stiffness. NOVALGIN dosage: unknown. During the same period patient was treated with IBUPROFEN, BRISERIN. Patient recovered.


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agranulocytosis, aphthous stomatitis, cellulitis, haemorrhage, leukopenia, neutropenia, pyrexia, thrombocytopenia, was diagnosed with pain, deep vein thrombosis, hypertension, osteoporosis and was diagnosed with pain, deep vein thrombosis, hypertension, osteoporosis, pulmonary embolism and