December 1, 2005 -- ROCKVILLE, MD -- 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: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm.
Source: The Food and Drug Administration