The hottest drug for weight loss these days is semaglutide (Ozempic, Rybelsus and Wegovy). Don’t let the three brand names confuse you. They are all the same medication. The FDA approved the self-injectable Ozempic for type 2 diabetes in 2017. An oral version of semaglutide, Rybelsus, got the FDA green light in 2019, also for type 2 diabetes. Another self-injectable semaglutide, Wegovy, received FDA approval for weight loss in 2021. In 2022 social media and Tik Tok videos got people excited. Then major media picked up the story. Thanks to all the publicity both Ozempic and Wegovy are, according to the FDA, “currently in shortage.” That has been the situation for months. One key question is will Wegovy weight loss last? Another: how will Wegovy affect cardiovascular health?
New Study on Cardiovascular Consequences of Wegovy:
This week the manufacturer, Novo Nordisk, announced the results of a large phase 3 clinical trial. More than 17,000 overweight or obese people who had been diagnosed with cardiovascular disease participated in this multi-year study named SELECT.
Wegovy reduced the likelihood of cardiovascular deaths, non-fatal heart attacks or non-fatal strokes by 20% compared to placebo. That relative risk reduction was statistically significant. We are awaiting further data to determine the absolute risk reduction when it comes to cardiovascular risk factors and overall mortality.
That will be essential when doctors and patients weigh benefits against risks. If insurance does not cover the cost of Wegovy, the list price is over $1,300 per month.
Fast Weight Loss Is Scary!
We have been told over and over that losing weight is hard. But quick weight loss is actually pretty easy. When people go on very strict diets under controlled conditions, they often lose weight.
That’s also true when people are faced with serious health conditions. Graves’ disease is an autoimmune condition that affects the thyroid gland. It kicks the thyroid into overdrive (hyperthyroidism) and often leads to rapid weight loss because metabolism is dramatically increased.
Severe congestive heart failure and pancreatic cancer can also lead to rapid weight loss. No one wants to lose weight this way!
The Weight Loss Boomerang:
Most healthy people who lose weight quickly also gain it back when they stop dieting. And because it is hard to stay on a strict regimen for a long period of time, diet programs often fail.
Let’s be honest for a moment. You can cut out carbs or fat and lose weight. But many of us eventually give in to our cravings. For some it may be pizza or pretzels. Others can’t withstand the siren call of a hot fudge sundae. And once we fall off the wagon, so to speak, we revert back to old habits.
Here is a message from a reader about this boomerang effect:
“I have had type 2 diabetes for 20 years and have been overweight my whole life. I have tried every diet you can imagine (plus pills and shots in the 1960s). I did lose weight, however after going off any of these things the weight always came back. The only way I ever lost weight was starving myself, which I cannot and WILL NOT do anymore.”
An often cited article in The American Psychologist, April, 2007 states:
“The authors review studies of the long-term outcomes of calorie-restricting diets to assess whether dieting is an effective treatment for obesity. These studies show that one third to two thirds of dieters regain more weight than they lost on their diets, and these studies likely underestimate the extent to which dieting is counterproductive…In sum, there is little support for the notion that diets lead to lasting weight loss or health benefits.”
A more recent review is the medical literature is not reassuring (Nutrients, Nov. 2019):
“The major conclusion of this review is that there is insufficient evidence to conclude that a low carbohydrate or low-fat diet is superior as a means to prevent obesity or to achieve or maintain weight loss.”
What About Drugs? Will the Wegovy Weight Loss Program Work?
How does semaglutide (either as Wegovy or Ozempic) work? This injectable drug mimics a natural hormone called GLP-1 (glucagon-like peptide 1) that helps the body regulate blood sugar and appetite. Elon Musk, among others, has been using Wegovy for fast weight loss. How safe and effective are these drugs?
The FDA has approved a Wegovy weight loss indication. Ozempic has FDA approval only for type 2 diabetes. That has not stopped some doctors from prescribing Ozempic for weight loss, though.
There are some important caveats to the Wegovy weeight loss approach, though:
“Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014.”
The FDA explains the Wegovy weight loss concept:
“Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.”
How Effective Is the Wegovy Weight Loss Approach?
First, let’s be clear that we are not recommending this drug for weight loss: fast, slow or in between! It was FDA approved only for people who have a very serious weight problem. It is not intended to help people lose 5 to 10 pounds so they look great in a bathing suit.
There were four clinical trials that tested Wegovy. According to the agency, 2,600 patients received the drug for more than a year and 1,500 patients took placebos. The average body weight was 231 pounds. These were obese patients!
The FDA states:
“The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.”
The FDA adds that over the 68-week trials:
“Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo.”
In another clinical trial involving obese patients (BMI was 36 kg/m2) with type 2 diabetes:
“…individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.”
Readers Weigh in on the Ozempic or Wegovy Weight Loss:
The hope is that this once-a-week self-injected medication will lead to significant weight loss. It reduces hunger and might help individuals change their relationship with food.
One reader described her experience with semaglutide:
“After abysmal efforts to lose weight, I was placed on Ozempic. The results have been amazing! I feel full so quickly, and my sugar cravings have stopped. I am down 30 pounds over six months and plan to lose another 35 pounds or so.
“I am so relieved to have insurance coverage for this medication because I was certain that I would get diabetes if I kept going in the wrong direction. I agree that Ozempic is inappropriate for casual weight loss. My BMI was nearly 38, so this was appropriately indicated.”
Another reader is also enthusiastic:
“As someone who suffers from food addiction and PCOS [polycystic ovary syndrome], losing weight isn’t easy for me. My next step was going to be gastric bypass because my weight was affecting my health and daily activities.
“Wegovy changed my life. It has taken away my cravings and stress eating. I can now take my dogs on a walk. I am much more active as well as incredibly happy. I am going to the gym and have a personal trainer.”
They are not the only ones. We have received a number of messages from people who have lost significant amounts of weight while taking semaglutide, either as Ozempic or Wegovy.
Will Wegovy Weight Loss Last?
There are growing reports from people who stopped Wegovy either because of side effects or the cost. According to GoodRx.com, a month’s supply may run between $1,300 and $1,700. This organization points out that:
“Wegovy is not covered by most Medicare and insurance plans…”
Most people cannot afford the Wegovy weight loss approach month in and month out. What happens when someone stops the medication?
One study found that a year after discontinuing semaglutide injections, participants had regained two-thirds of the weight they had lost (Diabetes, Obesity and Metabolism, April 19, 2022). In addition to the medication, patients received “lifetyle intervention.”
The authors report:
“After withdrawal of semaglutide and structured lifestyle intervention, participants regained a mean of two-thirds of their prior weight loss in the 1-year off-treatment extension phase; weight regain continued until the end of follow-up (week 120).”
The authors conclude that “continued treatment to maintain weight loss” will likely be necessary to keep the pounds from coming back.
Another substantial study published in JAMA (April 13, 2021) also noted:
“…participants who switched to placebo at week 20 gradually regained weight. The benefits of continuing semaglutide treatment for 68 weeks, rather than switching to placebo after 20 weeks, are consistent with findings from other withdrawal trials of antiobesity medications. These results emphasize the chronicity of obesity and the need for treatments that can maintain and maximize weight loss.”
The Wall Street Journal article quotes Lisa Moskovitz, “a registered dietitian and CEO of NY Nutrition Group.”
“When you stop taking it, you lose that feeling of fullness, that benefit of not being as hungry. And now your hunger signals and cues can become a lot stronger.”
In other words, once you start on semaglutide you will have to stay on semaglutide if you want to maintain the weight loss. That would be beneficial to the drug company. If people have to spend over $1,300 a month indefinitely to keep their weight off, the drug could become the goose that laid a lot of golden eggs.
What About Semaglutide Side Effects?
This story has more than one side, however. Some people describe unbearable reactions.
Here is one example:
“I tried this drug for my type 2 diabetes and was incredibly sick for the three months I tried it. I missed weeks at work and felt utterly hopeless while the ‘intestinal apocalypse’ wreaked havoc on life!”
Many people accept nausea, vomiting or diarrhea as the price they are willing to pay to lose weight. Others, however, cannot tolerate more serious complications. These include pancreatitis, gallbladder problems, thyroid tumors, kidney damage and depression.
Pancreatitis is a big deal! You can probably figure this out without a lot of help. It is inflammation of the pancreas. According to the official prescribing information, doctors should monitor for signs and symptoms of pancreatitis!
“persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting.”
We would go further and add nausea, tenderness when touching the belly area, bloating, fever, rapid heart rate, jaundice (yellow skin or eyes) or reduced blood pressure. Any of these symptoms require immediate medical attention and cessation of semaglutide.
Speaking of serous problems with the pancreas, Trudi writes that a friend’s mother was not tested for the cancer genes BRCA1 and BRCA2. They predispose people to pancreatic cancer:
“I have a friend whose mother died of pancreatic cancer. She went on this drug with her doctor NOT having recommended testing to see if she was BRACAI or BRACAII. I think that if testing had been done this drug should have been contraindicated.”
This is a highly controversial issue. A review published in the journal Frontiers in Endocrinology, July 8, 2021 notes:
“Within years of the introduction of GLP-1RAs, these agents were linked to the occurrence of acute pancreatitis, and suggested to potentially cause pancreatic cancer. In the subsequent years, many pharmacovigilance and database studies followed, with conflicting results.
“…These data thus argue against an effect of GLP-1RA on pancreatitis and pancreatic cancer incidence. However, one can wonder whether the follow-up duration in the CVOTs [cardiovascular outcome trials] (ranging from a median of 1.3 to 5.4 years) is long enough for patients to develop pancreatic cancer.”
The black box warning. This is the highest alert the FDA puts out for any drug it approves. It represents a serious safety concern.
In the case of Ozempic and Wegovy the boxed warning states:
“In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures.
“Wegovy [or Ozempic] is contraindicated in patients with a personal or family history of MTC [medullary thyroid carcinoma] or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).”
Doctors are supposed to inform patients about symptoms of thyroid tumors. They include:
“ a mass in the neck, dysphagia [difficulty swallowing], dyspnea [shortness of breath], persistent hoarseness.”
Other Serious Side Effects:
Kidney injury has also been reported with semaglutide. Gallbladder disease is another complication. Some people can develop severe allergic reactions to the injections leading to swelling and anaphylaxis. This is a life-threatening reaction.
Common adverse reactions include nausea, vomiting, diarrhea, abdominal pain and constipation. Distinguishing between “normal” digestive complications and symptoms brought on by pancreatitis might be challenging.
Other side effects of semaglutide include eye problems in patients with diabetes, headache, fatigue, indigestion, burping, flatulence and low blood sugar levels.
One reader who was taking Ozempic for type 2 diabetes wanted to know about fatigue:
Q. What is it in Ozempic that makes you so exhausted?
A. Doctors prescribe semaglutide (Ozempic) to control blood glucose for people with type 2 diabetes. The most common side effects are stomachache, nausea, vomiting, diarrhea or constipation.
Some people also report feeling tired, though it is considered an uncommon complication. We do not have an explanation for this adverse reaction, though you should monitor your blood sugar levels to make sure they don’t fall too low. If that were to happen, symptoms might include dizziness, shakiness, fatigue, headache and difficulty concentrating.
Oh yes, there is one more caveat: The FDA warns about:
“depression or suicidal behaviors or thoughts”
The Straight and Skinny on Wegovy Weight Loss:
Want to learn more about Wegovy for weight loss? Here is a link to a prior article on The People’s Pharmacy website. It provides some of the balance found in the scientific literature. You will also get some insight on gallbladder disease associated with similar diabetes drugs.
If you would like to watch an Ozempic TV commercial, we provide a link in this article. The light-hearted music and catchy jingle will absolutely grab your attention. Be sure to count the smiles during the warning phase of the commercial!
What Do You Think About Ozempic or Wegovy for Fast Weight Loss?
Please share your thoughts about semaglutide below in the comment section. Have you had to stop Ozempic, Rybelsus or Wegovy for some reason? Did the weight come back? We are interested in a balanced perspective on this medication so please let us know how it has worked for you.