FDA Takes Action: Ozempic Label Updated For Intestinal Blockage Awareness

The US Food and Drug Administration has made safety labeling changes for Semaglutide (Ozempic) products, warning users of the increased risk of ileus, a blockage that prevents food or liquid from easily passing through the abdominal intestinal space.

In the labeling change, the FDA emphasized that the change was based on voluntarily reported events from a population of uncertain size and, therefore, it is not always possible to reliably estimate or to establish a causal relationship with drug exposure.

FDA also issued an additional label update highlighting that people using Semaglutide in combination with an insulin Semaglutide may be at increased risk of hypoglycemia, including severe hypoglycemia.

With the new labeling information, those using Semaglutide should consider reducing the dose. Meanwhile, in a recent development, the FDA has directed the label of Novo Nordisk diabetes type 2 drug ( Ozempic) to acknowledge some users’ reports of ileus or intestinal blockage, whereas, Wegovy and Mounjaro also GLP-1 agonist medications, already acknowledge reports of ileus on their label.

Novo Nordisk is the maker of both Ozempic and Wegovy which are both used as (Semaglutide) injection prescriptions.

Though it is too early to fact-check that Ozempic is the root cause of the gastrointestinal complications reported by drug users, this recent report joins more than 14,000 other causes of Ozempic side effects reported since 2018.

Almost 9000 of these cases have been linked to various gastrointestinal Issues like vomiting, diarrhea, nausea, upper abdominal pain, and abdominal dissension. The side effects known by the medical term ileus are also labeled on the weight loss drug Wegovy also made by Novo Nordisk and in the diabetic medication Manjaro made by Eli Lilly.

This prompted the FDA mandating the Novo Nordisk, the maker of Ozempic, to warn users of the drug’s intestinal blockage effect.

The two drugs, Ozempic and Wegovy are generally known as Semaglutide, out of 8,500 users who report gastrointestinal disorders after using Semaglutide medications through June, 33 of such cases including two deaths reported ileus.

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This is not the first time Semaglutide has been mentioned in publication in 2023 based on FDA action. A recent shortage of GLP-1 receptor agonists as far back as 2022 placed a serious strain on the health system, combined with an increased number of people using the drug outside label prescription as weight loss medications, this increased demand has resulted in a rise of unapproved compounded Semaglutide, which prompted an FDA warning.

Ozempic Maker, by late June 2023 had begun legal action against certain medical spas, weight loss or wellness clinics, and compounding pharmacies to desist from false advertising, trademark infringement, and/or unlawful sales of non-FDA approved compounded products claiming to contain Semaglutide.

The North American operations and president of Novo Nordisk in a June 2023 statement said “Our priority is to ensure that patients have a safe and positive experience with FDA-approved Semaglutide medicine, and these actions are a direct reflection of that focus”.

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He further said, we believe it is 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.

With this information from the North American operations president, it is therefore necessary to educate the public and most especially users of Semaglutide medications on appropriate needs to verify the authenticity of Semaglutide medications they tend to consume, and that should be done appropriately following the instructions and prescription use of such medication. This will help to limit the purchase of FDA-non-approved Semaglutides that are commonly used either in the treatment of type 2 diabetes or for weight loss.

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