New FDA warning on Human Immune Globulin Products - IG

New FDA warning on Human Immune Globulin Products  -  IG

The U.S. Food and Drug Administration (FDA) is requiring manufacturers to add information on thrombosis to the current boxed warning in the labels of all intravenous human immune globulin products and 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.

fda.gov/BiologicsBloodVacci...

Patients should ...

Be aware that thrombosis is associated with human immune globulin products.

Talk to your healthcare professional about any risk factors or concerns you may have.

~chris

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  • Thanks for this information post. It is something that a few of us have been aware about but information was scant.

    Nick

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