Ozempic Label Does Not Include Gastroparesis Warning

Ozempic label changesI recently wrote about the start of what may become a wave of lawsuits against the maker of Ozempic due to certain side effects from that medication. In particular, several users claim that Ozempic and related drugs caused their gastroparesis, or the slowing (or stopping) of food from the stomach to the small intestine. The primary argument is that the Ozempic label did not contain adequate warnings concerning potential side effects.

After this litigation began, Novo Nordisk (the maker of Ozempic) updated the Ozempic’s label. Could this have been in response to the existing litigation or fear of future litigation? We don’t know, but let’s take a look this recent product label change, including how it relates to earlier changes and the labels for similar drugs.

An Overview of Ozempic and Related Medications

The U.S. Food and Drug Administration (FDA) approved Ozempic in 2017 to help individuals deal with Type 2 diabetes. Over the next few years, the FDA approved similar drugs using the same active ingredient as Ozempic, such as Wegovy. This medication is essentially a higher-dose version of Ozempic aimed at helping individuals lose weight.

There was also Rybelsus, which is like Ozempic, but the medication gets taken orally with a pill. In contrast, Ozempic and Wegovy are injected through the skin.

The labels for all of these drugs have undergone revisions over the past few years since their initial approval. The most recent update to Ozempic’s warning label concerns a condition called ileus.

What Is Ileus?

Ozempic and gastroparesisIleus is a medical condition where the bowel does not work properly. This can lead to an intestinal blockage which can be a serious health issue and require immediate medical attention.

The connection between Ozempic and Ileus is not definite. The FDA notes that one reason for the labeling change is the result of voluntary reports about potential problems with the medication.

Many of these reports come from the FDA Adverse Event Reporting System (FAERS), which is open to the public. This means consumers, doctors, pharmaceutical companies and other health professionals can submit information to this system.

Seeing adverse reactions to Ozempic on FAERS doesn’t automatically mean Ozempic was the cause nor does it establish how often these problems could occur. That being said, as of September 30, 2023, there were 16,854 adverse reaction cases involving Ozempic on FAERS. Of these cases, 34 are claimed to involve ileus.

However, if Ozempic causes ileus, the number of cases reported to FAERS will probably rise. And there’s research data to support this link.

A study published in 2023 looked at rats given exenatide for one month. Exenatide is similar to semaglutide, which is the active ingredient in Ozempic. The results showed that the length of the rats’ small intestines increased by 9% and the weight of the small intestines increased by 31%. This enlarging of the small intestine could lead to intestinal obstructions.

The study also noted that the risk of intestinal obstruction goes up over time while taking exenatide. So the longer someone takes Ozempic, they could be increasing their risk of developing ileus.

Label History of Ozempic

The label for Ozempic has received multiple updates, and not just for ileus. Since it was introduced, Ozempic has gone through five label changes:

  • First label change: Came in 2020 and added language mentioning that Ozempic could be used to reduce the risk of heart attack, stroke or death in diabetic patients with heart disease.
  • Second label change: Came in 2021, with notable changes relating to the risk of hypoglycemia and serious allergic reactions, such as anaphylaxis.
  • Third label change: Came in March 2022, with most of the additions relating to potential risk of acute gallbladder disease.
  • Fourth label change: Came in October 2022 and discussed pregnancy risks when taking Ozempic.
  • Fifth label change: This is the most recent update and it came in September 2023. Significant updates involve the risk of severe hypoglycemia and ileus was added as an adverse reaction.

What About Gastroparesis?

What’s interesting about the Ozempic label updates is that none of them mentions gastroparesis as an adverse reaction. However, the updates have included additional information about delays with gastric emptying, but only within the context of drug interactions.

In contrast, Eli Lilly’s Mounjaro label includes more impactful wording when it comes to gastroparesis. Specifically, it states that patients with a history of severe gastroparesis should not take Mounjaro as the medication has not been studied in patients with severe gastrointestinal disease.

Mounjaro’s label has also gone through fewer label updates, with the sole update coming in July 2023. In this update, major changes include risk of severe allergic reactions, pancreatitis and thyroid C-cell tumors. There was also mention of ileus as an adverse reaction.

Clay HodgesIf you think you’ve suffered a side effect from taking Ozempic and you believe it caused ileus, gastroparesis or any other notable health concern, be sure to mention it to your primary care provider. If these adverse reactions have been severe, it might be worth talking to a lawyer about your legal options. Feel free to contact my office or call me at 919.334.6277.

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