14/15 December 2023
The analysis of recent data by the U.S. Food and Drug Administration (FDA) has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. And the FDA suggested that additional caution regarding the use of these products is warranted.
The FDA is requiring manufacturers to add information on thrombosis to the current boxed warning in the labels of all intravenous human immune globulin products. They are also required to add a boxed warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and to add information on its mitigation. The currently given information about the risk of thrombosis in the WARNINGS and PRECAUTIONS sections of the labels of immune globuline products are not standardized. Because of this, FDA proposes that for thrombosis a more prominent placement of risk information and a uniform approach for communicating the risk and its possible mitigation will help to reduce the occurrence of these serious adverse events.
The information on thrombosis in the boxed warning states:
More details about FDAs recommendations can be found here.