FDA Adds New Warning for Ileus to Semaglutide (Ozempic) Label

Credit: US Food and Drug Administration

The US Food and Drug Administration has provided safety-related labeling changes for semaglutide (Ozempic) products, warning users of the potential for increased risk of ileus, a blockage that keeps food or liquid from passing through the colon.¹

In the labeling change, which was announced on September 20, 2023, the FDA pointed out the change was based on voluntarily reported events from a population of uncertain size and, as a result, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. On the same day, the FDA issued an additional label update highlighting those using semaglutide in combination with an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia, with new labeling information suggesting those initiating semaglutide use should consider reducing the dose of concomitantly administered insulin secretagogue, such as sulfonylureas or insulin, to reduce the risk of hypoglycemia.¹

A staple in the management of type 2 diabetes, semaglutide was initially approved by the FDA in 2017 in 0.5 mg and 1.0 mg dosages as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Novo Nordisk went on to develop an oral version of semaglutide and a 2.0 mg formulation, which received approval as adjuncts in type 2 diabetes in 2019 and 2021, respectively.²

According to the US FDA’s Adverse Events Reporting System (FAERS) public dashboard, there have been 2951 total cases of adverse events associated with use of Ozempic during 2023 as of June 30, 2023. The majority of these cases are gastrointestinal-related events, which account for 1274 of the 2951 total cases.

Within the FAERS public dashboard, there were 6 total cases of ileus reported with use of the agent, with 2 resulting in hospitalization. Of note, the number of cases reported so far in 2023 is more than double the total number of cases reported in 2019.

This is not the first time semaglutide has been headlines in 2023 based on FDA action. Ongoing shortages of the GLP-1 receptor agonist dating back to 2022 have placed a significant strain on health systems. This, combined with increased demand has resulted in a rise of unapproved compounded semaglutide, which prompted an FDA warning on May 31, 2023.² By late June 2023, Novo Nordisk had begun to file legal actions against certain medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.³

"Our priority is to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines, and these actions are a direct reflection of that focus," said Doug Langa, executive vice president, North America operations and president of Novo Nordisk, in a June 2023 statement.³ "We believe it's important to provide additional tools and education to support the proper use of our approved semaglutide products and create broad public awareness regarding the difference between our FDA-approved medicines and other products being labeled as semaglutide."

References:

1. Drug safety-related labeling changes (SRLC). Drug Safety-related Labeling Changes (SrLC). September 22, 2023. Accessed September 28, 2023. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2183.
2. Campbell P. SEMAGLUTIDE shortage prompts FDA warning to patients, providers. HCP Live. June 7, 2023. Accessed September 28, 2023. https://www.hcplive.com/view/semaglutide-shortage-prompts-fda-warning-to-patients-providers.
3. Novo Nordisk. Novo Nordisk takes actions to help protect US patients from unlawful sales of non-FDA approved medicines claiming to contain semaglutide. Novo Nordisk. June 20, 2023. Accessed September 28, 2023. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=166121.