Risk of Thrombotic Events with Vivaglobin Health Canada Warns

Ottawa, ON: CSL Behring Canada Inc, in collaboration with Health Canada, is warning the public and health care professionals of post-marketing reports that indicate an association of serious thrombotic events with the use of Vivaglobin, Immune Globulin Subcutaneous (Human).

Vivaglobin is authorized for the treatment of adult and pediatric patients with primary immune deficiency (PID).

Post-marketing reports indicate that the use of Vivaglobin, a subcutaneous immune globulin product for treatment of primary immune deficiency (PID), has been associated with very rare serious thrombotic events, including deep venous thrombosis, pulmonary embolism and stroke. Nineteen thromboembolic events (TEES) have been reported internationally in patients treated with Vivaglobin; no Canadian cases have been reported.

When reported, risk factors in post-marketing thrombotic event reports for Vivaglobin, have included pre-existing cardiovascular disorders, prior thrombotic event, obesity, oral estrogen use, hyperlipoproteinemia, in-dwelling catheter, and immobility.

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Published on Apr-14-11