New Study Links Ozempic and Wegovy to Serious Gastrointestinal Conditions, Stomach Paralysis

The FDA has, thus far, received 14,149 adverse events reports for Ozempic, out of which, 6,253 were ‘serious cases,’ including 163 deaths.
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Semaglutide, an active ingredient found in popular weight loss drugs Ozempic and Wegovy, has been found to have a range of adverse health issues for users, including serious stomach conditions like paralysis and gastroparesis in diabetics, according to a new study.

The drugs work by mimicking a hormone, Glucagon-like peptide 1 (GLP-1), which makes users feel satiated after eating. Consumed for weight maintenance, it regulates appetite, and delays gastric emptying and gut motility in humans.
The Oct. 5 study, published in JAMA Network, examined gastrointestinal adverse events related to GLP-1 agonists. The study looked at health insurance claim records for approximately 16 million U.S. patients who were prescribed two main GLP-1 agonists between 2006 and 2020, including semaglutide, the active ingredient in Wegovy and Ozempic. Researchers investigated how many non-diabetic people who used these medications developed one of the four gastrointestinal conditions:
  • Biliary disease which is a group of conditions affecting the gallbladder.
  • Pancreatitis, inflammation of the pancreas that can result in severe abdominal pain and end up requiring hospitalization and surgery.
  • Bowel obstruction, in which the food cannot pass through the large or small intestine, leading to symptoms like cramping, nausea, bloating, and vomiting. Depending on the seriousness of the condition, surgery may become necessary.
  • Gastroparesis, also known as stomach paralysis, restricts the passage of food from the stomach to the small intestine. This can also cause abdominal pain, vomiting, and nausea.
The GLP-1 agonists were compared to the weight loss drug bupropion-naltrexone, which is sold in the United States under the brand name Contrave.
The study found that compared to bupropion-naltrexone, GLP-1 agonists were associated with 9.09 times higher risk of pancreatitis, 4.22 times higher risk of bowel obstruction, and 3.67 times higher risk of gastroparesis. Though GLP-1 agonists also had a higher incidence of biliary disease, the difference was found not to be statistically significant.

The research was conducted by the University of British Columbia, Canada. “While previous studies highlighted some of these risks in patients with diabetes, this is the first large, population-level study to examine adverse gastrointestinal events in non-diabetic patients using the drugs specifically for weight loss,” according to an Oct. 5 news release by the University of British Columbia.

“Given the wide use of these drugs, these adverse events, although rare, must be considered by patients thinking about using them for weight loss,” said author Mohit Sodhi, a graduate of UBC’s experimental medicine program.

“The risk calculus will differ depending on whether a patient is using these drugs for diabetes, obesity or just general weight loss. People who are otherwise healthy may be less willing to accept these potentially serious adverse events.”

Risk of Gastrointestinal Issues

GLP-1 agonists were initially developed to help manage type 2 diabetes. But, over the past decade, the use of these drugs skyrocketed due to their use as off-label weight loss medication. In 2022, around 40 million of these drugs were prescribed in the United States.

Some GLP-1 agonists were approved for obesity treatment only in 2021. The initial randomized clinical trials, which looked at the efficacy of the medication on weight loss, were not designed to assess gastrointestinal events that can occur due to their use.

The anti-diabetic medication Ozempic (semaglutide) made by Danish pharmaceutical company Novo Nordisk, in Paris on Feb. 23, 2023. (Joel Sage/AFP via Getty Images)
The anti-diabetic medication Ozempic (semaglutide) made by Danish pharmaceutical company Novo Nordisk, in Paris on Feb. 23, 2023. Joel Sage/AFP via Getty Images

The UBC researchers aimed to fill this gap in knowledge. Though the adverse events measured in the latest study are rare, hundreds of thousands of people could still be impacted as the drugs are consumed by millions of individuals worldwide.

“These drugs are becoming increasingly accessible, and it is concerning that, in some cases, people can simply go online and order these kinds of medications when they may not have a full understanding of what could potentially happen. This goes directly against the mantra of informed consent,” Mr. Sodhi said.

Researchers hope that drug regulators and manufacturers would consider updating warning labels related to GLP-1 agonists, said the university news release.

“This is critical information for patients to know so they can seek timely medical attention and avoid serious consequences,” Mr. Sodhi said.

Both Ozempic and Wegovy are manufactured by Danish pharma company Novo Nordisk. In an emailed statement to The Epoch Times, Kate Hanna, Director of Communications at the firm, said that the company “stands behind the safety and efficacy of all of our GLP-1RA medicines when used consistent with the product monograph and approved indications,”

The company admitted that product monographs for Novo Nordisk’s Saxenda, Ozempic, Rybelsus, Victoza and Wegovy include details of potential side effects like “pancreatitis, acute gallbladder disease and delayed gastric emptying.”

“As the authors acknowledge, the study has limitations, including potential confounding by indication and by other factors. It is also important to note that the study analyzed data collected during the period between 2006 and 2020. During this time, Wegovy was not on the market in Canada,” she said, adding that Ozempic was only approved in the country in 2018.

“Treatment decisions should be made together with a healthcare provider who can evaluate the appropriateness of using a GLP-1RA based on assessment of a patient’s individual medical profile.”

FDA’s List of Risks for Ozempic

The UBC study comes as the U.S. Food and Drug Administration (FDA) last month updated its safety-related labeling for Ozempic. On Sept. 22, the agency added the gastrointestinal disease “Ileus” as an adverse reaction.
Ileus is a condition in which the intestines lose the ability to contract temporarily, thereby restricting the movement of food and waste in the body.
A sign for the Food and Drug Administration (FDA) outside of the headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)
A sign for the Food and Drug Administration (FDA) outside of the headquarters in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images
According to the FDA’s Adverse Events Reporting System (FAERS), there have been 14,149 adverse events reports related to Ozempic as of Oct. 6. This includes 6,253 “serious cases,” including 163 instances of death.

Out of the 14,149 adverse reactions, 6,177 were related to gastrointestinal disorders, 3,789 were concerning  injury, poisoning, and procedural complications, and 3,599 were linked to general disorders and administration site conditions.

There were 2,598 nervous system disorders, 2,549 metabolism and nutrition disorders, and 1,211 skin and subcutaneous tissue disorders.

Other complications like eye disorders, musculoskeletal and connective tissue disorders, infections and infestations, and psychiatric disorders had around 1,000 adverse events each. Cardiac disorders, renal and urinary disorders, and respiratory disorders were also reported.

The official Ozempic website warns that the drug can cause “serious side effects,” including inflammation in the pancreas, low blood sugar, changes in vision, serious allergic reactions, kidney issues, and gallbladder problems.

It advised users to inform their healthcare provider in case they develop a lump or swelling in their neck, have trouble swallowing, or suffer shortness of breath, as these may be symptoms of thyroid cancer.

Even though Ozempic is used for weight loss, the FDA has only approved the medication for Type 2 diabetes. In contrast, Wegovy has been approved by the FDA to treat obesity.
Wegovy can cause serious side effects, including cancer, according to the drug’s official website. Wegovy also shares Ozempic’s potential side effects like inflammation of the pancreas, higher risk of low blood sugar, changes in vision among people with type 2 diabetes, and allergic reactions.