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U.S. Department of Health and Human Services

Safety

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NovoSeven Coagulation Factor VIIa (Recombinant)

Audience: Hematological and other healthcare professionals

[Posted 12/01/2005] Novo Nordisk and FDA notified healthcare professionals of revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for NovoSeven, to provide updated safety information on thrombotic and thromboembolic adverse events, based on clinical studies in non-hemophilia patients and on post-marketing safety surveillance. A clinical study in elderly, non-hemophiliac, intracerebral hemorrhage patients indicated a potential increased risk of arterial thromboembolic adverse events with use of NovoSeven, including myocardial ischemia, myocardial infarction, cerebral ischemia and/or infarction.

[November 23, 2005 - Letter - Novo Nordisk]