A recent study indicates that individuals who are using popular injected weight loss medications like Wegovy, Ozempic, Saxenda, and Victoza may face a higher likelihood of experiencing severe digestive issues such as stomach paralysis, pancreatitis, and bowel obstructions compared to those using other types of weight loss medications.
Although the study revealed that the occurrence of these events in individual patients is relatively uncommon—approximately 1% of individuals using Ozempic were diagnosed with stomach paralysis, for instance—the demand for these drugs has skyrocketed, with millions of people worldwide now using them. According to researchers, even these rare risks could potentially translate into hundreds of thousands of new cases.
"When there are millions of individuals using these medications, a 1% risk can still impact a significant number of people who may encounter these occurrences," commented Dr. Mahyar Etminan, the primary author of the study and an epidemiologist at the University of British Columbia.
Additionally, the authors of the study highlight that these complications are substantial, as they can potentially lead to urgent medical situations, such as bowel obstructions.
CNN previously reported on incidents of stomach paralysis in individuals who had consumed these medications, emphasizing the absence of patient warnings regarding this particular side effect.
The prescribing information for Wegovy and Saxenda does provide cautionary statements concerning numerous severe side effects, such as pancreatitis, gallbladder issues, intestinal blockage, kidney problems, severe allergic reactions, accelerated heart rate, suicidal tendencies, and alterations in vision among individuals with diabetes. Additionally, a recent update to Ozempics warning label now includes a warning about ileus, or intestinal blockage.
The most frequently experienced side effects, as indicated by the labels, include nausea, vomiting, and constipation. Additionally, individuals with a background of specific hereditary thyroid cancers are strongly cautioned against the usage of these medications.
The diabetes drug Ozempic and its sister drug, Wegovy, which is approved for weight loss, have recently soared in popularity.
David J. Phillip/AP
The FDA has revised the label for Ozempic to acknowledge reports from certain users about experiencing blocked intestines. A research letter published in JAMA conducted by University of British Columbia researchers analyzed a random sample of over 16 million insurance claims from a prescription drug database spanning from 2006 to 2020, covering approximately 93% of all outpatient prescriptions in the US.
They searched for patients who were given two injected medications, semaglutide and liraglutide. Both drugs belong to a class known as GLP-1 agonists and slow down the movement of food in the stomach. These medications can assist individuals with diabetes in managing their blood sugar levels and can also result in significant weight loss for individuals with or without diabetes.
In 2021, the US Food and Drug Administration granted approval for semaglutide to be used by individuals who are obese and do not have diabetes but require weight loss. It is marketed as Ozempic when prescribed for diabetes and as Wegovy for weight loss purposes. Liraglutide has been approved by the FDA as a weight loss medication since 2014. It is referred to as Victoza when prescribed for diabetes and as Saxenda for weight management. However, even before these drugs were officially available for weight loss, doctors had noticed their benefits and had already been prescribing them off-label to patients in need of shedding pounds.
To identify the individuals, researchers sought out patients who had received an obesity diagnosis at least 90 days prior to commencing the medication. Those who had been diagnosed with diabetes or were using any other medication to manage their blood sugar were excluded from the study. The occurrence of severe digestive issues in these patients was then compared to that of individuals using a different weight loss medication, known as bupropion-naltrexone or Contrave, which is marketed in pill form.
An Ozempic (semaglutide) injection pen is seen on a kitchen table in Riga, Latvia on 06 August, 2023. (Photo by Jaap Arriens/NurPhoto via Getty Images)
Jaap Arriens/NurPhoto/Getty Images
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Through the years of investigation, researchers unveiled that individuals consuming Ozempic and Saxenda exhibited a significantly higher likelihood of experiencing severe stomach and intestinal complications in comparison to those prescribed Contrave.
Explicitly, the rate of new instances of stomach paralysis in the Ozempic group was approximately 1%, around 0.7% for the Saxenda group, and roughly 0.3% for the Contrave group.
People who took the injected drugs were over three times more likely to develop stomach paralysis compared to those taking Contrave. In the group taking Ozempic, there were no instances of bowel obstructions, but for those taking Saxenda, the incidence was 0.8%, and for those taking Contrave, it was 0.17%. This indicates that people on the injected medications were over four times more likely to experience bowel obstructions compared to those on Contrave.
The incidence of pancreatitis in individuals taking Ozempic was 0.5%, while those taking Saxenda had a risk of 0.8%. In contrast, the incidence of pancreatitis in individuals taking Contrave was only 0.01%, representing a more than ninefold increase.
Additionally, researchers examined the risk of biliary disease diagnosis among the groups but found no significant differences.
In the cohort of approximately 600 patients receiving Ozempic, four instances of gastroparesis or gastric paralysis, two instances of pancreatitis, no occurrences of bowel obstructions, and five cases of biliary disease were observed.
Among the population of approximately 4,400 individuals using Saxenda, there were 66 incidents of gastric paralysis, 73 occurrences of bowel obstructions, 71 instances of pancreatitis, and 162 cases of biliary disease.
In contrast, out of approximately 650 individuals who were taking Contrave, there were three occurrences of stomach paralysis, two instances of bowel obstructions, one case of pancreatitis, and 16 cases of biliary disease.
Emily Wright
Courtesy Emily Wright
Having consumed popular medications for weight loss and diabetes, individuals find themselves with a paralyzed stomach. However, it is crucial to acknowledge the limitations of this study as it is merely observational, thus only able to establish connections and unable to definitively establish causal links between the drugs and the diagnosed conditions.
Researchers made efforts to mitigate potential biases in their findings by excluding individuals with diabetes, a population already predisposed to an elevated risk of gastroparesis, pancreatitis, and biliary disease. Mohit Sodhi, a medical student exploring the adverse effects of commonly prescribed medications, explained that this exclusion allowed for a more precise examination of the potential associations between the drug and the respective conditions.
Researchers attempted to locate individuals who potentially utilized the medications for weight reduction, but due to insufficient documentation in their medical records, it remains uncertain if that was their intention. Nonetheless, this represents the initial instance where researchers have quantified these dangers, which were previously only described anecdotally by doctors and patients.
Experts not involved in the study have acknowledged that it was well conducted but have pointed out some limitations, suggesting that it should not be considered the ultimate authority. Dr. Ian Musgrave, a molecular pharmacologist at the University of Adelaide in Australia, stated in a press release given to the non-profit Science Media Centre in the UK that GLP-1 agonists are typically well tolerated but have a low occurrence of serious side effects.
Musgrave stated that inflammation of the pancreas, or pancreatitis, is a documented side effect of these agents in patients with type-2 diabetes. However, it has been uncertain whether patients using these medications for weight loss may also experience these severe side effects.
According to Musgrave, the study findings may be influenced by the disparity in the number of patients using injectable drugs compared to those using Contrave. Additionally, although the study authors controlled for factors such as age, sex, alcohol consumption, smoking, and high cholesterol, they did not compare the impact of body mass index (BMI).
The study findings are valuable for doctors prescribing these drugs and patients considering taking them, according to the speaker. CNN contacted Novo Nordisk, the manufacturer of Ozempic and Saxenda, for comment. Novo Nordisk expressed its confidence in the safety and effectiveness of all its GLP-1 medications when used as directed in accordance with product labeling and approved indications.
In regards to the study, the company acknowledged the limitations, including the possibility of confounding factors. They stated that it is advised for patients to take these medications for their approved indications and under the guidance of a healthcare professional. The company emphasized the importance of making treatment decisions in collaboration with a healthcare provider who can assess the suitability of using a GLP-1 based on the patient's unique medical profile.
A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023.
Jim Vondruska/Reuters
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The researchers observe that these issues likely did not arise during the clinical trials that resulted in their approval due to insufficient size of the studies to detect these uncommon adverse effects, or because the studies categorized these events as symptoms without investigating their root causes.
"The primary indications of gastroparesis include nausea and vomiting, so individuals may have reported experiencing nausea and vomiting, but it is important to examine the actual underlying causes," stated Sodhi.
Sodhi conveyed his motivation to conduct the study after providing care to a patient in the emergency department who experienced frequent vomiting, up to 15 to 20 times per day. The medical team initially struggled to determine the cause until they discovered that the patient was taking Ozempic. Sodhi disclosed that the patient's condition significantly improved after initiating medication for managing stomach paralysis. He further suggested that it is plausible that the patient experienced this particular adverse event.
CNN Health's weekly newsletter is also urging regulatory agencies and drug makers to revise their current warning labels by including the risk of gastroparesis.
Sign up now for The Results Are In with Dr. Sanjay Gupta, delivered to you every Tuesday by the CNN Health team. According to Sodhi, this valuable knowledge is essential for patients to be aware of, allowing them to promptly seek medical attention and avoid any severe repercussions.
And they anticipate that their investigation will enable individuals to make better-informed choices concerning the usage of these medications.
"Sodhi stated that someone with diabetes who is using this medication to manage their condition might be more inclined to accept the minimal risk of these rare side effects in order to effectively control their diabetes."
"But individuals who are generally in good health, and perhaps seeking to shed a few pounds, could reconsider taking these medications if they had a clearer understanding of their potential impact."