FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.

Recommendation

14/15 December 2023

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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:

• Thrombosis may occur regardless of the route of administration.
• Risk factors include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors.
• Thrombosis may occur in the absence of known risk factors.
• For patients at risk of thrombosis, administer at the minimum concentration available and at the minimum rate of infusion practicable.
• Ensure adequate hydration in patients before administration.
• Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

More details about FDAs recommendations can be found here.