December 1 , 2005

FDA ALERT

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

NovoSeven Coagulation Factor VIIa (Recombinant) : increased risk of thromboembolic adverse events

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.

Read the complete MedWatch 2005 Safety summary, including links to the Dear Healthcare Professional letter and revised prescribing information, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#NovoSeven