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Overview
The FDA recently approved a Safety Labeling Change (SLC) addressing the risk of necrolytic migratory erythema (NME) with continuous intravenous glucagon use. This change has been made because of case reports of NME, including three pediatric and three adult cases. All of the pediatric cases were also reported to the FDA Adverse Event Reporting System (FAERS). The first citation below contains two of the pediatric cases. One adult case (Mullans, et al.) was only available from the literature; the other two adult cases were also reported to FAERS. The FDA does not know the incidence of NME nor the incidence of off-label use of glucagon.
For the full wording of the label change, please log in.
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