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A new study shows that people taking popular injectable drugs for weight loss such as Wigoby, Ozempic, Saxenda, and Victoza are more likely to experience gastroparesis, pancreatitis, and intestinal obstruction than those taking other types of weight-loss drugs. It has been suggested that patients may be at increased risk of serious gastrointestinal illness. Medicine for loss.
The study found that the risk of these events occurring in individual patients is rare, with about 1% of people taking Ozempic being diagnosed with gastroparesis, for example.But the demand for drugs exploded, tens of millions of people around the world are now taking them. Researchers say even such a rare risk could result in hundreds of thousands of new cases.
“With millions of people using these drugs, “A 1% risk means many people could still experience these events,” said Dr. Mahyal Etminan, an epidemiologist at the University of British Columbia and lead author of the study.
The study authors also note that these problems are not trivial. For example, a bowel obstruction can be an emergency.
previous CNN coverage It highlighted cases of gastroparesis in people who took these drugs and the lack of warnings to patients about their specific side effects.
Wegovy and Saxenda’s prescribing information states that they may be used for a number of conditions, including people with pancreatic inflammation, gallbladder problems, intestinal obstruction, kidney problems, severe allergic reactions, increased heart rate, suicidal thoughts, vision changes, or similar symptoms. Warnings about serious side effects. suffer from diabetes. A warning about ileus, or intestinal obstruction, has just been added to Ozempic’s warning label.
The label also states that the most common side effects are nausea, vomiting, and constipation. Also, people with a history of certain types of hereditary thyroid cancer are strongly warned not to take the drug.
for studyIn the paper, published as a research letter in JAMA, researchers at the University of British Columbia analyzed a random sample of more than 16 million insurance claims from a prescription drug database that covers approximately 93% of all outpatient prescriptions in the United States. I selected it. The complaints were filed between 2006 and 2020.
They looked for patients who were prescribed two types of injectable drugs: semaglutide and liraglutide. Both drugs belong to a class called GLP-1 agonists, which slow the passage of food through the stomach. These help diabetics control blood sugar and lead to significant weight loss in people with and without diabetes.
In 2021, the U.S. Food and Drug Administration approved semaglutide for obese people who don’t have diabetes and just need to lose weight. When prescribed for diabetes, it is sold under the brand name “Ozempic” and when prescribed for weight loss, it is sold under the brand name “Wegovy.” Liraglutide was approved by the FDA in 2014 as a weight loss drug. When prescribed for diabetes, it is called Victoza. When prescribed for weight management, it is called Saxenda. But even before weight loss drugs officially hit the market, doctors recognized their benefits and began prescribing them off-label to patients who needed to lose weight.
To deduce who those patients are, researchers looked for people who were diagnosed with obesity at least 90 days before starting the medication, and those who were diagnosed with diabetes or used to control blood sugar levels. People taking other medications were excluded.
They then compared the frequency of severe gastrointestinal illness in those patients to the same set of people taking another type of drug, bupropion naltrexone (sold as a pill called Contrave), for weight loss. compared to the problem.
After years of research, researchers found that people: Ozempic and Saxenda were much more likely to develop serious stomach and intestinal problems than those taking Contrave.
In absolute terms, the incidence of new gastroparesis in the group taking Ozempic was approximately 1%, the incidence of gastroparesis in the group taking Saxenda was approximately 0.7%, and the incidence of gastroparesis in the group taking Contrave was approximately 1%. The incidence was approximately 0.3%. .
Relatively speaking, this means that people taking the injection drug were more than three times more likely to develop gastroparesis than those taking Contrave.
No intestinal obstructions were observed in the group taking Ozempic, but the study found an incidence of 0.8% in those taking Saxenda and 0.17% in those taking Contrave. got it. In other words, people taking the injection drug were more than four times more likely to have a bowel obstruction than those taking Contrave.
Regarding pancreatitis, those taking Ozempic have a 0.5% risk of pancreatitis, those taking Saxenda have a 0.8% risk, and those taking Contrave have a 0.01% risk, which is 9 times more likely. This shows an increase of more than
The researchers also looked at the risk of patients being diagnosed with biliary tract disease, a group of problems that affect the gallbladder and bile ducts, and found no significant differences between the groups.
In a group of about 600 patients taking Ozempic, four developed gastroparesis or gastroparesis, two developed pancreatitis, no intestinal obstruction, and five developed biliary tract disease.
In a group of about 4,400 people taking Saxenda, 66 had gastroparesis, 73 had intestinal obstruction, 71 had pancreatitis, and 162 had biliary tract disease.
In contrast, in a group of about 650 people taking Contrave, three had gastroparesis, two had intestinal obstruction, one had pancreatitis, and 16 had biliary tract disease.
Research has limitations. Since this is observational, we can only show an association. It cannot be proven that drugs are the cause of the symptoms people have been diagnosed with.
But the researchers say they tried to control for several things that could have biased the results.
“For example, people with diabetes already have a higher risk of gastroparesis, and they also have a higher risk of pancreatitis and bile duct disease,” said study author Mohit Sodhi, a medical student who studies adverse events of commonly prescribed drugs. he says. Sodhi said excluding them from the study allowed them to more carefully figure out what the link was between the drug and the disease.
Researchers took steps to find people who may have been using the drug for weight loss, but their medical records did not indicate this, so they could not be certain why they were taking the drug. There is no way to know.
Still, this is the first time researchers have been able to quantify these risks, which previously were only explained to doctors and patients who were aware of them.
Experts not involved in the study said it was well conducted but had limitations and could not be finalized.
“GLP-1 agonists are generally well tolerated, but the incidence of serious side effects is low,” said Dr. Ian Musgrave, a molecular pharmacologist at the University of Adelaide in Australia, in a statement about the study given to the nonprofit organization. mentioned in. British Science Media Center.
For example, Musgrave said inflammation of the pancreas, or pancreatitis, is a known side effect of these drugs in patients with type 2 diabetes. What is less clear is whether patients taking these drugs for weight loss may experience similar serious side effects.
One thing that could affect the study results is that there were far more patients taking the injection drug than taking Contrave, Musgrave said. . Second, while the study authors controlled for data such as age, gender, alcohol consumption, smoking, and high cholesterol, they may not have compared the effects of body mass index or BMI.
Still, he said the findings are a valuable contribution to doctors prescribing the drug and patients considering taking it.
Novo Nordisk, which manufactures both Ozempic and Saxenda, said it stands behind the safety and efficacy of all of its GLP-1 medicines when used in accordance with the product label and approved indication.
““As the authors acknowledge, this study has limitations, including possible confounding by indication and other factors,” the company said in a statement to CNN.
“Patients are advised to take these drugs for approved indications and under the supervision of a medical professional. Treatment decisions depend on assessment of the patient’s individual medical profile. “This should be done in collaboration with health care providers who can assess the appropriateness of GLP-1 use based on
The researchers said these issues probably influenced approval for drilling because the study was not large enough to capture some of these rare adverse events, or because the study recorded these events as symptoms rather than symptoms. They point out that it did not appear in linked clinical trials. Dig into the root cause.
“The main symptoms of gastroparesis are nausea and vomiting, so although people may complain of nausea and vomiting, it’s something to consider to find out the real etiology of what’s going on,” Sodhi says.
Sodhi said he was inspired to do the research after treating a man in the emergency room who was vomiting 15 to 20 times a day. Doctors couldn’t figure out what was causing it until they realized he was taking Ozempic. Sodhi started the man on medication to treat gastroparesis, and he said he was “much better.”
“There’s a good chance he had this type of adverse event,” he said.
In the meantime, researchers hope that regulators and drug manufacturers will consider updating warning labels on their products, which do not currently include the risk of gastroparesis.
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“This is important information that patients need to know so they can seek timely medical attention and avoid serious consequences,” Sodhi said.
And they hope their research will help people make more informed decisions about medications.
“People who have diabetes and are taking this drug for that reason may be more willing to accept the risk of rare adverse events in order to control their diabetes,” Sodhi said.
“But people who are otherwise healthy and want to lose a little weight, if they essentially have a better idea of what conditions they’re likely to end up in, can use these It could change whether you take your medication or not.”
However, obesity also comes with its own significant risks, which need to be taken into account, said Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University in the UK. Koch was not involved in the study and no drug-related conflicts of interest were reported.
“Obesity significantly increases the risk of developing cardiovascular disease, type 2 diabetes, cancer, gallbladder disease, and stroke. These risks are dramatically reduced by sustained, clinically meaningful weight loss. ” Kolk said in a statement to the nonprofit Science Media Center. “For the vast majority of patients targeted for these drugs, the most severely obese, the benefits of weight loss far outweigh the risks.”
