Wegovy Side Effects and Informed Consent - Part 2

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In part 1 we discussed the types and rates of side effects for Wegovy. Today we’re going to discuss the claim that reader Connie’s doctor made that the weight loss drug Wegovy “has been around forever and is safe.”

This claim is, at best, misleading. Wegovy is Novo Nordisk’s brand name for the weight-loss version of the drug semaglutide. It’s a re-purposed version of the same drug that Novo sells for Type 2 Diabetes under the brand name Ozempic. Ozempic received FDA approval in December of 2017 for dosages up to 1mg. A 2mg dose did not receive FDA approval until March of 2022.  

That’s not so much “forever” as it is a little less than 6 years (and less than 2 years at the 2mg dose.) Information about the risks of Ozempic is definitely still developing, just last month the FDA updated the Ozempic warning label to include a risk of Ileus (a near or total cessation of peristalsis in the intestines leading to an inability of the body to eliminate solid waste which is typically temporary but may require a hospital stay.) Wegovy’s warning label already acknowledged this risk and so, prior to last month, Connie’s doctor should have been clear that even the Wegovy and Ozempic warning labels did not show the same side effects.  This class of drugs has been around longer than that but, again, has steadily racked up new side effects and warnings and has not been prescribed in doses specifically meant to maximize side effects, as Wegovy is being dosed.

The main difference between Ozempic and Wegovy in treatment is dosage and titration – basically how much medication is given and when, and by how much, that amount is increased. Both drugs begin dosage at .25mg. This is known as a “non-therapeutic” dose – this amount of the medication has little effect, this is just to let the body start getting used to the medication in the hopes of reducing side effects. At four weeks, both medications are increased to .5mg. At that point, things change.

The main on-label purpose of Ozempic is to help manage blood sugar so the medication is increased only if the patient isn’t getting the glucose management they would like and they are able to tolerate the side effects, up to a maximum dose of 2mg.  Wegovy’s on-label purpose is to induce weight loss – basically, it’s taking a drug that was created to manage Type 2 Diabetes that has a side effect of weight loss, and it’s trying to cause that side effect to occur at the highest rate possible. So, per the FDA-approved documentation, dose escalation is to happen at four-week intervals until the patient reaches the maximum dose of 2.4mg and the patient stays at that dose for the rest of their life unless they can’t tolerate the side effects of the drug at which point they are recommended to “temporarily” drop to 1.7mg for four weeks and then increase back to 2.4mg and “Discontinue WEGOVY if the patient cannot tolerate the 2.4 mg dosage.” That’s an issue since we know from Novo Nordisk’s own study that patients who discontinue the drug rapidly regain the weight they lost and lose cardiometabolic benefits.

So the required dose of Wegovy is more than the maximum dose Ozempic (and remember that until 2 years ago the maximum Ozempic dose was 1mg, or less than half the required dose for Wegovy. While this is to produce a higher rate of the side effect of weight loss (though it’s far from clear that the weight loss will be sustained, even if people keep taking the drug) it also tends to produce a higher rate of all of other potential side effects.

So going back to Connie’s doctor's statement. When she asked about Wegovy’s side effects he said they are ‘nothing to worry about’ and that ‘all drugs have side effects’ and ‘besides, this drug has been around forever and is safe.’

As a reminder, 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 much more information than that.”

Or

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

For all the reasons in this piece and in part 1, what Connie’s doctor said simply isn’t accurate. Whether or not the practitioner is well-meaning, these kinds of vague platitudes fall woefully short of anything that would qualify as the informed consent conversation that is ethically required of a healthcare practitioner and there is absolutely no excuse they could give that would make it ok.

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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 Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.