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For more information on HIT, please visit the following Educational Web sites listed below: The www.argatroban.com web site contains links to third-party Web sites on the Internet. These links are provided as a service to individuals interested in more information in HIT. These sites are not part of this GlaxoSmithKline (GSK) Web site. The content and materials in these third-party Web sites are not produced or endorsed by GSK and may refer to uses of our products that are not recommended by GSK. Indications Important Safety InformationAs with all anticoagulants, bleeding is a serious concern. Argatroban is contraindicated in patients with overt major bleeding or those with hypersensitivity to the product or any of its components. Argatroban should be used with extreme caution in disease states or other circumstances in which there is an increased risk of hemorrhage. Overall major bleeding was reported in 5.3% of patients with HIT treated with Argatroban versus 6.7% of the historical controls. Overall major bleeding was reported in 1.8% of patients undergoing PCI treated with Argatroban versus 3.1% of the historical controls. Intracranial bleeding was not observed in the 568 patients treated with Argatroban for HIT (with or without thrombosis) or in the 91 patients who underwent PCI. The most common nonhemorrhagic side effects in HIT patients, regardless of the relationship to treatment, were dyspnea, hypotension, and fever. In patients undergoing PCI, the nonhemorrhagic side effects, regardless of the relationship to treatment, included chest pain, hypotension, and back pain. Please see full Prescribing Information for additional safety information on Argatroban. |