The FDA has updated the label for semaglutide, which is widely used for weight loss and type 2 diabetes (Ozempic, Novo Nordisk). These updates now address the potential risk of ileus and an increased risk of hypoglycemia when used in conjunction with insulin or insulin secretagogue. 

The updated warning was included in the drug-interaction section of the semaglutide label, reiterating the message found in other label sections. This emphasizes the potential interaction of the GLP-1 receptor agonist semaglutide with specific agents, heightening the risk of hypoglycemia.

According to the updated guidelines, when initiating semaglutide, patients should consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia as recommended in the Warnings and Precautions and Adverse Reactions section of the label.

The second label update is related to the identification of a new adverse reaction, specifically gastrointestinal ileus, during the post-marketing experience. Within the post-marketing adverse reactions classification, it is noted that these adverse events were documented during the post-approval utilization of semaglutide.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure

- US Food and Drug Administration.

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References:

https://www.fiercepharma.com/pharma/novo-nordisks-ozempic-gets-label-warning-intestinal-blockage-disorder

https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2183#

Disclosures: MD /alert could not confirm financial disclosures at the time of reporting.

By Dave Quaile, MD /alert Contributor

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