Weight Loss Drug Wegovy Could Offer More Risks Than Benefits

Weight Loss Drug Wegovy Could Offer More Risks Than Benefits
Weight Loss Drug Wegovy Could Offer More Risks Than Benefits
Suzanne B. Robotti
Suzanne B. Robotti Executive Director

The Food and Drug Administration (FDA) has now approved the diabetes drug Wegovy (semaglutide), previously okayed for diabetes, for weight loss. I wonder why? I was the consumer representative on the FDA advisory panel that voted to approve Wegovy (semaglutide) for diabetes. I voted for it reluctantly and only because the drug helped slightly improve life for those with diabetes.

Is Wegovy worth it?

A small weight loss is one benefit of Wegovy. Patients given Wegovy in clinical trials lost between five and ten pounds. That’s helpful for a person with type-2 diabetes, but for the average person, it is a minor change in body weight. Most overweight people need to lose weight at a far higher rate to become healthier or avoid risks of medical conditions.

Wegovy weight loss is a side effect. Those who should not take Wegovy seem to be causing medication shortages for those that should.

The average weight of an American man is 199 pounds, women are 171 pounds. Experts tell me a weight loss, even that small, can improve the health of people with diabetes. But for everyone else, what is the difference between 199 and 189 or 171 and 166 pounds? Weight related medical problems are not likely to change much with a loss of just a few pounds.

The side effects of Wegovy are very scary and, in my opinion, would outweigh the benefits of someone taking the Wegovy shot just for such minor weight loss. Below are my blog and thoughts when the FDA approved Wegovy in 2017 for diabetes. I have even more concerns now. 

In short, those seeking to focus on weight management need far more lifestyle change than the Wegovy medication offers.

(2017) A Trail of Clues to a New Diabetes Drug

Last week, I sat on an FDA panel as the lone consumer rep to discuss and vote on an application for a diabetes drug, semaglutide, from Novo Nordisk. This is a new entry in the category of GLP-1 agonists, six of which are already approved for use in diabetes.

The benefits are clear and strong: semaglutide lowers glucose levels and helps patients drop weight by [what I thought at the time was] a significant level, five to 10 pounds on average. Lowering glucose levels is the surrogate marker that the FDA uses to measure the benefits of new diabetes drugs. The FDA allows surrogate markers because waiting to prove or disprove that a drug lengthens or improves the lives of diabetics would take decades. 

However, the side effects are pretty bad. At least 20% of the trial participants had to drop out because they couldn’t take the nausea, diarrhea and constipation. (This is a problem with other GLP-1 agonists, too.) These symptoms could lead to using drugs for side effects. At least one doctor on the panel voiced the obvious: with so much gastric distress, no wonder patients lost weight.  

The primary killer of people suffering with diabetes is CVD (cardiovascular disease). https://www.cdc.gov/features/diabetes-heart-disease/index.html The FDA looks closely at the effects of any diabetes drug that could impact CVD. For that reason, in addition to five other clinical trials, Novo Nordisk ran a two-year trial called SUSTAIN 6 that focused on CVD, with a secondary consideration on diabetic retinopathy, a problem that blinds half of all diabetics.

SUSTAIN 6 had mixed results. Happily, it showed a significant decrease in most of the CVD measurements. Compared to the placebo and to comparator drugs, those taking semaglutide had substantially lower rates of non-fatal MI (myocardial infarction, or heart attack), non-fatal stroke, revascularization (needed surgery for bypass or other heart vascular issue) or hospitalization for an unstable angina (poor blood flow to heart). 

Unfortunately, data also showed semaglutide slightly increased the risk of being hospitalized for heart failure and had about the same risk (as compared to a placebo) of a cardiac death. Deaths from all causes were about the same as with a placebo. On balance, the drops were significant and the increases small.

Of concern was that diabetic retinitis showed a definite increase among users of semaglutide compared to the placebo. In tests of other GLP-1 agonist drugs, this same pattern had been shown and named “Early Worsening.” In years three and four, the rapid onset slowed, and soon the placebo group’s retinitis symptoms increased well past the tested drug group. However, Novo Nordisk didn’t continue the test to prove or disprove that this drug, semaglutide, would follow the same pattern. In addition, the quality of the research conducted on retinopathy wasn’t good. The preferred tests for retinopathy were not conducted and the data collection was inconsistent. We can hope, but cannot assume, the rapid increase in retinopathy that semaglutide causes will level off. Therefore, the doctors on the panel agreed that retinitis progression at a rapid rate is a real possibility.  

The eye doctors on the panel discussed and assured the rest of us that there were many procedures for doctors to slow retinitis, and, in their opinion, this was a manageable problem. The greater concern to diabetics, they all agreed, was CV risk, where semaglutide showed a clear benefit. 

The above issues I had to leave to the experts. These doctors were trained in medical research and statistics. However, I know that the population upon which a drug is tested must reasonably compare to the population that will likely use the drug. Diabetes is much more common among the non-Hispanic Black and Hispanic populations. Yet the trial participants were 80% white (with the exception of the two trials that were conducted in Japan). 

The appropriate patient population is just as important as correct dosing and timing. I was the first panelist to raise this question, and only one doctor added his concern to mine. He abstained from voting yes or no. I wish I’d thought of abstaining as an option. I voted yes, but I remain very worried. Here are my remarks to the committee (lightly edited for clarity): 

“Semaglutide does show a lowering of glycemic levels and body weight. It doesn’t seem to cause hypoglycemia as often as its comparator drugs [the drugs to which semaglutide was tested against]. The committee has convinced me that retinopathy is manageable and that the lack of CV harm is a greater benefit. It has significant side effects and adverse events that cause a large percent of patients to stop using the drug.

“I am concerned about the race and ethnic makeup of the trial participants and the lack of subgroup analysis. Black non-Hispanics have the second-highest rate of diabetes, but are so underrepresented in these trials that the actual black patients number in the low 100s.

“The lack of significant subgroup analysis also concerns me. With such small samples it is impossible to know if it has differing effects and safety among women or ethnic groups.

“Considering the commonality of retinopathy with diabetes, it is surprising to me that the research was not gathered in a standardized method and which made it not of the best quality. The applicant seems to be depending on other studies of other drugs to conclude that the “Early Worsening” of retinopathy shown in their trials is temporary and that there will ultimately be a benefit to the patient. If semaglutide follows the pattern of other diabetes drugs, continuing the study for only one more year would have confirmed a pattern similar to other drugs. As it stands, the study stopped at two  years, which doesn’t allow any confirmation of benefit.

“The trial was particularly overwhelmingly white. Cardiovascular disease is the Number One killer of women, and it’s very high on the list of cause of death for black people; diabetes has a higher incidence rate in blacks and Hispanics, and they’re not well represented.

“History has shown that drugs tested on only one ethnic group or one sex can sometimes have surprising, and detrimental, effects on subgroups. 

“The lack of ability to do subgroup analysis concerns me. I’m going to feel pretty bad if we don’t go on record saying there should be more trial participants, and the trial should reflect the people who need the drug.

“I strongly recommend further study with better demographic representation that allows subgroup analysis to determine efficacy with blacks, Hispanics, women, etc. 

“We also need further tracking to find out about the long-term effect on retinopathy. 

“I think these further studies should be required, because the public has the right to full safety information.” 

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Joley Smith

I started Wegovy to lose weight December 2021 I have lost 30 pounds in 4 months and I’m still only on the 1 mg I have 20 pounds until I hit my goal weight. The side effects are not great but the weight loss is amazing and worth them! Many people are finally feeling success with their weight loss journey from this drug. My doctor who is a weight loss specialist thinks the medicine is the answer for a lot of people. Much less risky than bariatric surgery with the same outcome!

Joseph Farris II MD

According to the article the average wt loss was 15.3 kg vs 2.6kg in the placebo group. This is more than the 5-10 pounds you suggest. Only 7% (not 20%0 withdrew from the study. The side effects were mostly mild to moderate and transient. Further 86.4% lost 5% of their weight; 69% lost 10%, and 32 % lost 15%. These were all more than placebo. I agreee that there needs to be more subgroup analysis. Are you reading the same NEJM article i am?


I’ve had type 1 diabetes for 40 years. I’ve always struggled with my weight, and now that I am 53, it was even harder!! I was on Saxenda in 2021, it did not agree with me at all, and I barely lost anything. I started Wegovy last February, and I have lost almost 50lbs. My endocrinologist also put me on Metformin. Wegovy has been a game changer for me. Not only have I lost weight, but my A1C has been under 7, and I’m very happy! Only thing – you may lose your desire for certain foods. My big one has been coffee. Honestly, I don’t even miss it. Also, I did not exercise this past year, which I should have!
Now I just have to get rid of this loose skin! lol.
Take it one meal at a time.


The manufacturer claims average weight loss is 15-20% of body weight. There are very few people who would qualify for Wegovy weighing under 200 pounds. For a 300 pound person, 15-20% is 45-60 pounds, enough to get many morbidly obese people into class 2 obesity. That’s worth something. I’d rather deal with nausea than the risks associated with bariatric surgery, which is currently the only other obesity treatment proven to work.

Jon Stanley

This is a very misleading article. The data is based on the SUSTAIN-6 trial, https://www.nejm.org/doi/full/10.1056/NEJMoa1607141 – which has endpoints of nothing to do with weight loss, and was not a weight loss intervention. It also is a lower dose of the drug. The proper trial to be looking at is STEP 4, which is what this approval was based on – https://jamanetwork.com/journals/jama/article-abstract/2777886 . This trial was at 2.4mg, which is the maintenance dose, To quote the article, “During the run-in, 5.3% of participants discontinued treatment because of adverse events, most of which were gastrointestinal tract disorders”, not the 20% claimed.

Please be honest.


Started wegovy last July at 221 lbs. I’m 165 lbs right now. Horrible side effects for me, but I put up with them bc I work from home, so I was able to deal. I’m at the point where I am going to hit my goal weight, which I never in a million years thought was possible. I am terrified of what is going to happen to me when I stop the injections or when insurance cuts me off. Weight has been a life long battle that, for the first time in my life, I feel like I conquered. I’m not ready to give it up.


I am all for skepticism of pharm companies and their research; it is a pretty crooked industry. However, this is intentional misinformation from people who know better. Take note of a few clues. First, they (admin) clearly read every comment but only respond to those who toe the line. These people are asked to share anecdotes that fit the predetermined story. Second, they include links but the first link to the FDA is not to anything relevant, just the FDA landing page. So, you are left to search and guess what information this article is based on. Third and related, if you are going to quote a study, cite it (link) and use the correct one assuming 5-10 lbs is not a total fabrication. We can’t know if it is because it is not properly cited. The author is the President and Founder so they should be setting the tone on journalistic integrity for the entire site. Beware that misinformation is everywhere and often appears legit.

I dare them to approve this for posting.

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