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Review Dalteparin Safety Reports submitted to FDA

Total Dalteparin reports: 6.
Dalteparin FDA safety alerts: No.
   Reported hospitalizations: 6.
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FDA Reported Dalteparin Side Effects: caesarean section, electrocardiogram st segment elevation, atrial fibrillation, air embolism, cellulitis, hepatitis a, melaena, thrombocytopenia, tachycardia, hypotonia, premature baby.
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Dalteparin Side Effects Report #5670195-0
Physician from CZECH REPUBLIC reported DALTEPARIN problem on Feb 29, 2008. Female patient, 24 years of age, was diagnosed with cerebral venous thrombosis and was treated with DALTEPARIN. After drug was administered, patient experienced the following problems/side effects: altered state of consciousness, cerebral venous thrombosis, condition aggravated, intracranial venous sinus thrombosis, transverse sinus thrombosis. DALTEPARIN dosage: unknown. During the same period patient was treated with PROGESTERONE, ANTIBIOTICS. Patient was hospitalized. Patient recovered.

Dalteparin Side Effects Report #5682172-4
DALTEPARIN problem was reported by a Health Professional from UNITED KINGDOM on Mar 12, 2008. Female patient, 84 years of age, weighting 123.5 lb, was diagnosed with pulmonary embolism and was treated with DALTEPARIN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood bicarbonate increased, blood sodium decreased, haemoglobin decreased, hypertension, rectal haemorrhage. DALTEPARIN dosage: unknown. During the same period patient was treated with DILTIAZEM HYDROCHLORIDE, BENDROFLUMETHIAZIDE, CITALOPRAM, DESLORATADINE, MEGESTROL ACETATE, NEBIVOLOL, PERINDOPRIL ERBUMINE. Patient was hospitalized. Patient recovered.

Dalteparin Side Effects Report #5633045-4
Health Professional from UNITED KINGDOM reported DALTEPARIN problem on Jan 30, 2008. Male patient, 70 years of age, was diagnosed with pulmonary embolism and was treated with DALTEPARIN. After drug was administered, patient experienced the following problems/side effects: cellulitis gangrenous, injection site cellulitis, thrombocytopenia. DALTEPARIN dosage: unknown. During the same period patient was treated with FLUCONAZOLE, HALOPERIDOL, ACETAMINOPHEN, SALBUTAMOL, PIPERACILLIN AND TAZOBACTAM. Patient was hospitalized. Patient recovered.

Dalteparin Side Effects Report #5639070-1
DALTEPARIN problem was reported by a Physician from CZECH REPUBLIC on Feb 11, 2008. Female patient, 24 years of age, was diagnosed with cerebral venous thrombosis and was treated with DALTEPARIN. After drug was administered, patient experienced the following problems/side effects: central nervous system lesion, coma, condition aggravated. DALTEPARIN dosage: unknown. During the same period patient was treated with PROGESTERONE, ANTIBIOTICS. Patient was hospitalized. Patient recovered.

Dalteparin Side Effects Report #5612003-X
Physician from GERMANY reported DALTEPARIN problem on Jan 15, 2008. Male patient, 58 years of age, was diagnosed with thrombosis prophylaxis, hyperuricaemia, pain, nausea and was treated with DALTEPARIN. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. DALTEPARIN dosage: unknown. During the same period patient was treated with ALLOPURINOL, NOVAMINSULFON BRAUN, GABAPENTIN, METOCLOPRAMIDE, IBUPROFEN. Patient was hospitalized. Patient recovered.

Dalteparin Side Effects Report #5525128-4
DALTEPARIN problem was reported by a Pharmacist from UNITED STATES on Nov 19, 2007. Male patient, 35 years of age, was diagnosed with cardiac valve disease and was treated with DALTEPARIN. After drug was administered, patient experienced the following problems/side effects: coagulopathy, haemorrhage intracranial, international normalised ratio decreased, intraventricular haemorrhage. DALTEPARIN dosage: unknown. During the same period patient was treated with WARFARIN, QUETIAPINE FUMARATE, FAMOTIDINE, PROMETHAZINE. Patient was hospitalized. Patient recovered.


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altered state of consciousness, cerebral venous thrombosis, condition aggravated, intracranial venous sinus thrombosis, transverse sinus thrombosis, , was diagnosed with cerebral venous thrombosis and was diagnosed with pulmonary embolism and was diagnosed with pulmonary embolism and