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Posts : 904
Join date : 2007-12-09
Age : 58
Location : Near Ottawa, Ontario Canada.

PostSubject: Fragmin   Thu Dec 13, 2007 8:48 pm

FRAGMIN is contraindicated in patients with active major bleeding or with known hypersensitivity to the drug, heparin, or pork products, or with thrombocytopenia associated with a positive antiplatelet antibody test. It should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.

Patients undergoing regional anesthesia should not receive FRAGMIN for unstable angina or non–Q-wave myocardial infarction, and patients with cancer undergoing regional anesthesia should not receive FRAGMIN for extended treatment of sympotmatic VTE, due to an increased risk of bleeding associated with the dosage of FRAGMIN recommended for these indications.

In FRAGMIN clinical trials supporting non-cancer indications, platelet counts of < 100,000/mm3 and < 50,000/mm3 occurred in < 1% and < 1% of patients, respectively.

In a clinical trial of patients with cancer and acute symptomatic VTE treated for up to 6 months in the FRAGMIN treatment arm, platelet counts of <100,000/mm3 occurred in 13.6% of patients, including 6.5% who had platelet counts less than 50,000/mm3. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the FRAGMIN arm and 8.1% of patients in the oral anticoagulant arm. FRAGMIN dose was decreased or interrupted in patients whose platelet counts fell below 100,000/mm3.
Thrombocytopenia of any degree should be monitored closely. Heparin-induced thrombocytopenia can occur with administration of FRAGMIN. The incidence of this complication is unknown at present.
FRAGMIN, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage; bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site.
The most commonly reported side effect is hematoma at the injection site.
FRAGMIN cannot be used interchangeably (unit for unit) with unfractionated heparin or other low–molecular-weight heparins. (more...)

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Last edited by dero on Sat Sep 15, 2012 10:51 pm; edited 1 time in total
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