John Lindsey Kirkland, III June 24, 1942 – July 5, 2025 Pittsboro, North Carolina – John Lindsey Kirkland, III, of…
Read MoreMore Articles
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, changes have been made…
Read MoreThe 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) and a stable liquid…
Read MoreVitamin 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 health benefits are not…
Read MoreLevothyroxine 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 details regarding the product…
Read MoreOverview
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.
Not a member?
On January 18, 2018, the Trump administration announced it would be creating a “Division of Conscience and Religious Freedom” at the Department of Health and Human Services. This new office…
Read MoreThe Special Diabetes Program (SDP) supports research to prevent, treat, and cure type 1 diabetes and its complications and type 2 diabetes treatment and prevention strategies for American Indian and…
Read MoreMedia Release: Updated Information About Safety Events after Gonadotropin Releasing Hormone Agonist Therapy. 3/21/17 Dear Colleagues, On 2/2/17, Kaiser Health News published an article raising concerns about potential long-term side…
Read MoreWe are pleased to note that with unanimous approval of our Board of Directors, PES (in addition to other professional societies and academic centers in the U.S.) signed on to…
Read MoreThe House and Senate have been negotiating a large, bipartisan mental health package over much of the past year. The most recent draft of this package in the House (H.R.…
Read More