FDA Updates Ozempic Label to Include Blocked Intestines as Potential Side Effect

Ozempic
The FDA has updated the label of Ozempic to include blocked intestines among the potential side effect of the drug. Jaap Arriens/NurPhoto/Getty Images
  • The FDA is warning patients prescribed Ozempic about the potential to develop blocked intestines.
  • Blocked intestines, known clinicially as ileus, is a serious and potentially fatal condition.
  • Despite the label change, the FDA hasn’t directly attributed cases of blocked intestines to Ozempic use.

The Food and Drug Administration (FDA) has updated its labeling for the diabetes drug Ozempic to include a warning about blocked intestines, a potentially fatal side effect, following reports by consumers.

The FDA’s reporting system FAERS indicates that ileus, the medical term for blocked intestines, was reported 16 times by users of the drug Ozempic as of June 30, 2023.

Ozempic (which is prescribed to treat type 2 diabetes but can also be taken off-label to aid with weight loss) and its sister drug Wegovy (which is prescribed as an anti-obesity treatment), use the same medication, semaglutide.

They are part of a broader class of drugs known as GLP-1 agonists, which also includes the drugs Rybelsus and Mounjaro.

The FDA received more than 8,500 reports for gastrointestinal disorders related to semaglutide. Twenty cases of ileus were reported, including two deaths.

Both Mounjaro and Wegovy include warnings about ileus; now Ozempic’s label carries that warning as well.

Despite the label change, the FDA hasn’t directly attributed cases of ileus to Ozempic itself, stating, “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.”

Dr. Dan Azagury, Section Chief of Minimally Invasive and Bariatric Surgery and Medical Director for the Bariatric and Metabolic Interdisciplinary clinic at Stanford University, said the label change was “not completely surprising.”

“[Semaglutide] is a gut hormone. All of the very well known and very frequent side effects are all GI related. One of its mechanisms is to slow down how  fast your stomach empties. So, it’s in the realm of things that we know this drug does,” he told Healthline.

Ozempic and other members of the GLP-1 class of drugs work by mimicking a hormone produced in the gut in response to eating. The GLP-1 hormone causes the body to produce more insulin, hence why it is used in Ozempic and Rybelsus, both diabetes medications.

But GLP-1 also does other things to the body: it slows down how quickly food leaves the stomach, and affects parts of the brain that deal with “satiety,” or feeling a sense of fullness after eating.

Potentially serious side effects of drugs like Ozempic

Dr. Caroline Apovian, a Professor of Medicine at Harvard Medical School, and the Co-Director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital told Healthline that her team had observed ileus in patients that had been prescribed semaglutide well before the FDA’s label change.

“My team and I were probably one of the first to notice the side effect of ileus, small bowel obstruction,” she told Healthline.

According to Apovian, the number of individuals experiencing ileus was small, but it was enough to grab her attention.

The issue, she said, is constipation.

Constipation is a listed side effect of semaglutide, but left untreated can lead to far more serious outcomes like ileus, which have the potential to be fatal.

“I think that’s why the FDA is changing its labeling: ileus is a rare but potentially severe complication. So, we have to inform patients and we have to let them know that if they have these symptoms they need to check in with their physician,” said Azagury.

In some rare cases, patients have experienced a symptom known as “stomach paralysis” or gastroparesis, when the stomach takes too long to empty.

On August 2 of this year, Jaclyn Bjorklund, a 44-year-old woman from Louisiana filed a lawsuit against Novo Nordisk, the company behind Ozempic and Wegovy, and Eli Lilly, who make Mounjaro, another GLP-1 drug. Bjorklund lost 150 pounds while taking the two drugs and is suing the manufacturer for failing to warn about serious adverse gastrointestinal events.

“As a result of using Defendants’ Ozempic and Mounjaro, Plaintiff was caused to suffer from severe gastrointestinal events, which resulted in, for example, severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room,” the lawsuit claims.

In a statement provided to Healthline, Novo Nordisk, the pharmaceutical company that makes both Ozempic and Wegovy, said that they “work closely with the U.S. Food and Drug Administration to continuously monitor the safety provide of our medicines” and that “patient safety is a top priority.”

“Novo Nordisk stands behind the safety and efficacy of Ozempic and all of our medicines when used consistent with the product labeling and the approved indications” said the statement.

How to identify and help prevent blocked intestines while taking Ozempic

Ileus is the medical term for when a full blockage of the intestines takes place. It can be caused by muscle or nerve problems which stop the intestinves from properly contracting and moving food along through the intestines.

It can also be caused by physical obstructions such as food and waste material.

Without proper treatment, ileus can be extremely serious, resulting in a visit to the emergency department or death. Intestinal blockages can tear the intestine, causing the bowel contents to spill out into other areas of the body.

The best way to treat ileus is to never let it progress that far in the first place. So being aware of regularity in your bowel movements is essential.

“Don’t let it happen,” said Apovian, “If you find that you’re getting constipated, take a scoop of MiraLax every morning in water or in a shake. That’s the safest way to deal with constipation. If it doesn’t abate, then you need to see your doctor.”

The bottom line

The FDA has updated label warnings for the diabetes drug Ozempic to include intestinal obstruction, known clinically as ileus.

Other GLP-1 drugs carry similar warnings for gastrointestinal side effects, including ileus.

Ileus is potentially life threatening and individuals who are experiencing constipation for several days should consult their physician.

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