New Boxed Warning Added to Immune Globulin Products
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has instructed manufacturers to add information to the current boxed warning in the labeling of all intravenous immune globulin (IVIG) products, and add a similar standardized boxed warning for all subcutaneous and intramuscular IG products, which highlights the risk of thrombosis and includes recommendations to mitigate that risk.
While all human IG products already contain some information related to the risk of thrombosis in the current Warnings and Precautions sections of their labels, analysis of a large health claims-related database and postmarketing adverse event reports strengthened the evidence for an association between administration of these products and the risk of thrombosis.
The new boxed warning identifies certain risk factors for thrombosis and offers specific recommendations to mitigate this risk, including ensuring adequate hydration and administering product at the minimum practicable rate of infusion.
