Reader Question – Wegovy’s Side Effects - Part 1

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I received the following question from reader Connie: “My doctor is pushing me to take Wegovy. I told him I’m not interested in weight loss medication but the kept pushing so I said that I was worried about the side effects. He said they are ‘nothing to worry about’ and that ‘all drugs have side effects’ and that ‘besides, this drug has been around forever and is safe.’ I didn’t know what to say to that, can you help?”

This is certainly not the only time I’ve heard this and it is enraging every single time. In Part 1 we’ll talk about the first two claims, in Part 2 we’ll talk about the claim that the drug has been around forever and thus is safe.

Healthcare practitioners have an obligation to provide informed consent (I wrote about the specifics around this here) to any suggested treatment. They are supposed to do that without prompting, which is to say that the patient shouldn’t have to ask for accurate information about the potential risks of a proposed treatment, so it’s bad enough when we have to ask, but if we ask and then get blown off with “all drugs have side effects” or “it’s nothing to worry about” then that is a clear and direct violation of medical ethics.   

As I talked about in the piece I linked to above, this behavior often stems from provider weight stigma and paternalism. If the provider believes that being fat is proof that a patient isn’t competent to make their own decisions, and/or the provider thinks that the treatment is worth the risk, those beliefs (even if they are subconscious) can lead to the provider failing at their duty of informed consent and even purposefully under-informing or misinforming fat patients in order to get the patient to undertake a course of treatment that the practitioner thinks is best.

If this happens to you, you can say something like

“I’m asking for an informed consent conversation followed by a shared decision-making process, so I’ll need more information than that.”

Or

“Can you help me understand how you feel that constitutes informed consent?“

Let’s talk about the side effects. I did a deep dive into what Novo Nordisk is calling a “long-term” study of Wegovy (in fact, the study was only 2 years long, which is an example of weight science research making words mean whatever they want). Still their own numbers and the FDA-approved documentation show the seriousness of this situation.

Wegovy is contraindicated for those with a “personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 and/or with prior serious hypersensitivity reaction to semaglutide or to any of the inactive ingredients in WEGOVY. “Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.”

Wegovy can cause fetal harm and so it’s recommended that it be discontinued when a pregnancy is recognized. To me, it seems unclear to what extent that will help, given that they also warn “Females and Males of Reproductive Potential: Discontinue WEGOVY at least 2 months before a planned pregnancy because of the long half-life of semaglutide.”

Wegovy can also interfere with absorption of medications taken orally at the same time.

In addition to having a boxed warning (the FDA’s strongest warning) for a risk of Thyroid C-cell tumors, Wegovy has common side effects (meaning that they occur in 5% or more of subjects, with some of them occurring in 44% of subjects) including nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease, and nasopharyngitis. It also has serious side effects including acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity, diabetic retinopathy complications, heart rate increase, suicidal ideation and behaviors.

Concerningly, the FDA-approved documentation says that “To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-934-6891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” Given that Novo Nordisk has been sanctioned in two different counties for deceptive practices (for a similar medication and then for Wegovy itself,) maybe it’s better if folks just go ahead and call the FDA directly.

Back to the side effects. If we look at this by the numbers, Novo’s two-year Wegovy research found that per 100 patient years there would be:

·         532.3 adverse events

·         6 serious adverse events

·         4 events that lead to discontinuation of the drug

Those numbers have to be taken in the context of the prescribing recommendations. Novo’s research also shows that when people go off the drug they quickly regain their weight and lose cardiometabolic benefits. Novo’s (massively profitable) solution to that is for people to take the drugs for the rest of their lives. (Hence their strong-arm marketing tactics pushing phrases like “chronic lifelong health condition” and “relapsing remitting ob*sity”.) Beyond the deeper issues with considering simply existing in a higher-weight body to be a disease, taking the drug for life as a “treatment” means that those on the drug could rack up significant personal patient-years.

The average age of the semaglutide group in the “long-term” Wegovy trial was 47.3 years. If that is the age that someone starts taking the drug, and they live to 70 years old, that would be 22.7 patient years during which they could have 121 adverse events, 1.32 serious events, and  .9 events that lead to product discontinuation.

Now consider the concerning AAP guideline recommendation that children as young as 12 be put on this drug. If they live until 70 they could have 58 patient-years, with an average of 308 total adverse events, 3.48 serious adverse events, and 2.32 events that lead to product discontinuation.

From my perspective, these are not “don’t worry about it” numbers. But it doesn’t actually matter how I feel about it, or how a doctor feels about it for that matter – this information exists and it should be provided to patients in order to allow for their best chance of informed consent. Though, again, we don’t even have a single generation of patients who have taken this drug for their entire lives, so the practitioner should also make clear that the “long-term” data they are talking about is only for two years.

As always, I want to note that, in addition to using the seriously problematic BMI measurement, the FDA approval of this drug predicates risk on size. Those with a BMI of 27-30 must also have a “weight-related health issue” (with a reminder that “weight-related health issues” are health issues that people of all sizes have, that get called “weight-related” when fat people have them) in order for the FDA to consider this medication worth the risk. People with a BMI of 30 or above need only exist, regardless of any health status, for the FDA to consider the risks “worth it.” This is an example of the lives of those of the highest weights being seen as less valuable and more riskable by the healthcare system.

Those are the side effects, in part 2 we’ll look at the claim that Wegovy is safe because it’s been around “forever.”

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More research and resources:
https://haeshealthsheets.com/resources/

*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.