New Meds and Tech: Riomet ER™

Riomet ER™ (metformin hydrochloride for extended-release oral suspension) was approved by the U.S. Food and Drug Administration (USFDA) on August 29, 2019 and became available in…

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New Meds and Tech: Tandem® Diabetes Care Control-IQ Technology

In December 2019, the FDA announced approval of Tandem Diabetes Care Control-IQ™ Technology. Control-IQ Technology on the t:slim X2™ insulin pump can adjust basal insulin delivery…

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New Meds and Tech: New Cortisol Assays, New Threshold for Adrenal Insufficiency

 

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New Meds and Tech: Newer Insulin Preparation – Faster Insulin Aspart (Fiasp)

Fiasp (Novo Nordisk) is a faster insulin aspart with an earlier onset of action. In contrast to NovoLog, which is recommended to be dosed within 5-10 minutes before…

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New Meds and Tech: Increlex

In response to findings of a safety signal report that there is reasonable suspicion of a causal association between use of Increlex® and childhood neoplasia, including malignancy,…

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New Meds and Tech: Glucagon Preparations

The FDA has approved two new ready to use forms of glucagon and these have been introduced to the market: an intranasal powder (Baqsimi, Eli Lilly)…

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New Meds and Tech: Vitamin D Preparations and Safety Issues

Vitamin D is a fat soluble vitamin that is essential for maintaining bone health and also has other potential health benefits. While some of these other…

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New Meds and Tech: Tirosint-SOL

Levothyroxine sodium oral solution (Tirosint-SOL) has now been approved by the FDA and is available for use in the US. Please click on the link below for…

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New Meds and Tech: FDA Alert for Medical Providers Regarding Necrolytic Migratory Erythema (NME) with Chronic Glucagon Use

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.

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