The FDA authorized additional warning over the use of human immune globulin products after new data strengthened the connection between such products and thrombosis risk. Drugmakers will have to put additional risk information on the products' current boxed warning labels, while a box warning should be added to the labels of intramuscular and subcutaneous human immune globulin products. Additional data on risk mitigation strategies will also be a requirement.
New boxed warnings of clot risk ordered for immune globulin by FDA
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