Novo Nordisk and FDA ( U.S.Food and Drug Administration ) have notified HealthCare Professionals of revisions to the Warnings and Adverse Reactions sections of the prescribing information for NovoSeven ( recombinant coagulation Factor VIIa ) 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.

Warnings

The extent of the risk of thrombotic adverse events after treatment with NovoSeven in patients with hemophilia and inhibitors is not known, but is considered to be low.

Patients with disseminated intravascular coagulation ( DIC ), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with aPCCs/PCCs ( activated or nonactivated prothrombin complex concentrates ) may have an increased risk of developing thrombotic events due to circulating TF or predisposing coagulopathy.

The extent of the risk of arterial and venous thromboembolic adverse events after treatment with NovoSeven in patients without hemophilia is also not known.
A clinical study in elderly non-hemophilia 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.

Adverse reactions

The following additional adverse events were reported following the use of NovoSeven in both labeled indications and unlabeled indications that included individuals with situational coagulopathy and without known coagulopathy: high D-dimer levels and consumptive coagulopathy, thromboembolic events including myocardial infarction, myocardial ischemia, cerebral infarction and/or ischemia, thrombophlebitis, arterial thrombosis, deep vein thrombosis and related pulmonary embolism, and isolated cases of hypersensitivity reactions including anaphylactic reactions.

Evaluation and interpretation of these post marketing events is confounded by underlying diagnoses, concomitant medications, pre-existing conditions, and inherent limitations of passive surveillance. A causal relationship has not been established for the above events.

Source: FDA, 2005


XagenaMedicine2005