How safe are weight-loss drugs for children and adults?
Are weight loss drugs safe for your child?
Novo Nordisk, the manufacturer of blockbuster weight-loss drugs Ozempic and Wegovy, hopes that children as young as six could soon use liraglutide, another formulation of these drugs, to aid weight loss. Results of a small study, Novo Nordisk claims, show the drug is safe and effective for this age group, as reported by EuroNews,
An obesity drug from Danish drugmaker Novo Nordisk for adults and teens is safe and effective for use in kids as young as 6 when combined with diet and exercise, according to a small new study that could pave the way for the first obesity treatment for young children.
Liraglutide lowered body mass, slowed weight gain and improved health markers in kids ages 6 through 11, according to the research published in the New England Journal of Medicine and presented at the European Association for the Study of Diabetes in Madrid.
Ozempic, Wegovy, and liraglutide are part of a class of drugs called GLP-1 agonists, a synthetic version of GLP-1, the hormone that helps the body recognize satiety. It is currently approved for children 12-17 years old. Patients using these drugs are supposed to use them for life; if they stop the weight comes back on.
Stomach paralysis - a serious adverse effect
High and prolonged doses of GLP-1 in patients using these agonists have been linked to significant health issues. Yasmin Tayan, in her article for The Atlantic about GLP-1-boosting supplements, noted some of the adverse effects of these drugs including the black box warning regarding thyroid C-cell tumors, acute pancreatitis, gallbladder disease, hypoglycemia, acute kidney injury, complications of diabetic retinopathy in people with type 2 diabetes, increased heart rate, and thoughts of suicide. She did not mention gastroparesis or stomach paralysis, one of the most serious adverse effects.
An article penned by Brenda Goodman for CNN on gastric paralysis caused by GLP-1 agonists referred to a 2017 study conducted on patients taking liraglutide by Dr. Michael Camilleri, a gastroenterologist at the Mayo Clinic, who received a grant from the National Institutes of Health to study its effects on stomach function.
He recruited 40 obese adults and randomly assigned them to take increasing doses of liraglutide or a placebo, which had no active ingredients.
After five weeks, he had people in the study eat a meal laced with a radioactive tracer so he could see how long food stayed in their stomachs. People taking liraglutide had dramatically slowed digestion compared with those on the placebo; it took about 70 minutes for half the food they ate to leave their stomachs, compared with just four minutes in the placebo group. And that was just the average delay: In some patients on liraglutide, the time it took for half the meal to leave their stomachs was 151 minutes, or more than two and a half hours.
Camilleri said the group taking liraglutide lost weight, and the bigger the delay in food leaving the stomach, the more weight people seemed to lose.
Fortunately, people in the study seemed to adjust to the medication over time. After 16 weeks, people in the group taking liraglutide were clearing about half the food they ate from their stomachs in about 30 minutes, as opposed to seven minutes in the placebo group. Symptoms of nausea and vomiting seemed to ease, too
However, as Goodman also wrote, some people’s stomachs don’t empty for days, leaving them unable to eat and constantly throwing up. She described the plight of Joanie Knight who found she couldn’t eat any of her birthday dinner without throwing up. After a few bites she had to stop, the food felt as if it was stuck in her throat; she couldn’t swallow.
"Joanie Knight remembers exactly what she ate on her birthday in 2021. She ordered chicken fajitas at one of her favorite restaurants. She ate three skinny French fries and two or three pieces of chicken and then felt panic set in when she couldn’t swallow the food.
“It felt like it was stuck in my throat,” said Knight, who had been taking Ozempic for two years at that point and was already eating very little every day as a result. Her birthday dinner triggered a bout of violent vomiting.
“I thought, ‘I hadn’t eaten. How am I throwing up this much?’ ” she said.
Her gastroenterologist found her stomach was full of food.
She went to see a gastroenterologist, a doctor who specializes in stomach problems. They put a tube with a camera down her throat and into her stomach to see what the issue might be.
“They said, ‘your stomach is full of food,’ ” she said.
Knight had severe gastroparesis, Goodman continued. Four hours after a meal is consumed less than 10% of food will be left in the stomach; If 10% to 15% remains, it’s considered mild gastroparesis, 15% to 35% is moderate, and over 35% is severe. Knight's was diagnosed as severe. She complained of being continually nauseous and took prescription anti-nausea medicine “like it was candy.”
Doctors don't recognize gastroparesis as an adverse effect of these drugs; it's not explicitly mentioned in the drug's literature.
Still, doctors didn’t connect her stomach problems to the Ozempic she was taking. Although the prescription information for the drug warns of nausea and vomiting, it mentions only that the drug causes a delay in stomach emptying as a warning that it might affect the absorption of other medications. It was almost four more months until a specialist took her off the medication.
The FDA, Goodman notes, has received "reports of stomach paralysis among patients taking GLP-1 agonist drugs." However, the FDA is undecided about the cause:
“The FDA has received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report,” the agency said in a statement to CNN.
The reports have been submitted through the agency’s publicly accessible adverse events tracking system, and the FDA said there’s not always enough information in those reports to properly evaluate them.
The FDA said it has been unable to determine whether the medications were the cause or if the gastroparesis may have been caused by a different issue.
Manufacturers sued over gastroparesis, other adverse effects
The Gold Report described the serious adverse effects of these drugs and the many pending lawsuits that manufacturers Novo Nordisk and Eli Lilly are facing for not warning patients of their serious adverse effects; gastroparesis is the main complaint for many suing the companies.
Novo Nordisk, the maker of Ozempic and Wegovy, is facing lawsuits from patients across America who say they experienced extreme side effects which they were allegedly not warned about.
Thousands more patients have also come forward to claim they suffered adverse reactions to the drugs and attorneys say many more could join the growing legal campaign.
Most of the patients claim they suffered from gastroparesis, which is the medical name for paralysis of the stomach. The condition, which can be life-threatening, causes a build-up of food in the gut and symptoms include nausea, vomiting and severe pain.
DailyMail.com reviewed more than a dozen lawsuits filed since November by patients who were diagnosed with gastroparesis after using Ozempic and Wegovy, including some who suffered 'life-threatening' bowel injuries and face lifelong consequences.
In all of the lawsuits, Novo Nordisk is accused of failing to properly warn about the risk of gastroparesis on the drugs' packaging.
[Daily Mail reporter Lewis] Pennock also reported that at least ten lawsuits have been filed against Eli Lilly for failing to properly warn about Mounjaro's [a similar drug’s] risks.
What is the difference between Wegovy and liraglutide?
Technically, Ozempic is a drug taken to help patients manage diabetes, the original purpose for which the FDA approved it. However, once individuals realized that they were losing weight while on it, overweight people without diabetes began asking their doctors for Ozempic, at which point doctors started prescribing it off-label for weight loss. Wegovy was subsequently developed specifically for obese people without diabetes. They are both forms of generic semaglutide provided as weekly injectables with the dosing for Wegovy higher than for Ozempic.
Clinical pharmacist Sara Hoffman explained for Very Well Health that liraglutide is the generic name for Saxenda, a weight-loss drug approved in 2014 for overweight people without diabetes including children between 12 - 17 years old. (Victoza is the brand name of the version of liraglutide developed for people with type 2 diabetes.)
It’s meant to be used along with diet and exercise in people with a body mass index (BMI) at or above 30 kilograms per meters squared (kg/m²). This measurement is a person's weight in kilograms divided by their height in meters squared.
The FDA also approved its use in adolescents 12 to 17 years old who weigh more than 132 pounds (60 kg).
The difference between Wegovy and Saxenda, she noted, is in the dosing and frequency of use. While semaglutide drugs are injected once weekly, liraglutide is injected daily. They also stay in the body for different amounts of time.
[Wegovy] continues working for much longer than Saxenda. Wegovy is active for around 165 hours after injection, while Saxenda lasts just 13 to 15 hours.
According to a study she cited, Wegovy also leads to greater weight loss than Saxenda, when used in conjunction with an improved diet and exercise. This study focused on people “experiencing overweight or obesity who had at least one comorbidity such as hypertension, type 2 diabetes, or dyslipidemia.” However, both Wegovy and Saxenda were specifically formulated and approved for people without diabetes.
The difference between natural GLP-1 and synthetic GLP-1
Tayan explained that while natural GLP-1 degrades quickly, the synthetic version in obesity drugs can increase GLP-1 levels by over 1,000% and remains active for weeks.
. . . obesity drugs increase GLP-1 by more than 1,000 percent. The synthetic GLP-1 in obesity drugs lingers in the body for weeks after being injected; meanwhile, GLP-1 produced by the body is degraded within minutes, so hunger quickly returns.
How the natural hormone works
The following video by Nourishable with Dr. Lara, part 6 of its “Neurobiology of Food Intake module within a lecture series on the nutrition science of macronutrients,” illustrates the function of GLP-1 and the many different processes it acts upon to accomplish its job. While the content may be somewhat technical, it effectively demonstrates how the hormone impacts different parts of the body. As described in the description of the video,
GLP-1 is secreted by intestinal cells in response to glucose ingestion and acts on the vagus nerve and hypothalamus to induce satiety.
Worth the risk for your child or yourself?
Is potential weight loss with liraglutide or semaglutide worth the risk of adverse effects? Families and individuals considering these options can make informed decisions based on a clear understanding of the risks and benefits only after learning the details of those risks and benefits.
Doctor-recommended natural weight-loss strategies for you and your child will be explored in a follow-up article.
Related articles:
- Leading medical journal proposes anti-obesity drugs from toddler age for life
- Is weight loss with Ozempic and Wegovy worth the price?
- Whose job is it to explain side effects? Doctors? Pharmacists? Pharma? Yours?
- Big Pharma guiding doctors on how to discuss side effects
- Doctors under the influence - 6 things you need to know about pharma and the drugs your doctor prescribes
- What 'safe and effective' really means
- When public hears 'safe and effective' they hear '100% safe and effective' - Congressman Brad Wenstrup
The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer, or other qualified professional regarding any questions you may have about a medical condition, health objectives or legal or financial issues.
