Incretin Medications: Safety Considerations and Black Box Warnings

00:02 the FDA requires GLP-1 receptor agonists to carry a black box warning regarding the risk of thyroid CTL tumors.

00:10 Now, it recommends against using them in patients with a personal or family history of medullary thyroid cell cancer or multiple endocrine neoplasia syndrome.

00:19 Type two or type two B GLP-1 receptor agonist, regardless of the indication, are associated with over a tenfold increase in thyroid neoplasm and hyperplasia adverse event reporting when compared to SGLT-2 inhibitors was found in a recent study.

00:41 Now, the FDA has also added warnings about pulmonary aspiration to the labels of all GLP-1 receptor agonist medications in November 2024. Now, this warning applies when patients are undergoing general anesthesia or even deep sedation. Now, the FDA has also received reports of adverse events related to dosing errors for compounded injectable semaglutide products, and many people are getting their semaglutide as compounded medications. So as we wrap this up, the black box warnings medications. So as we wrap this up, the black box warnings include pulmonary aspiration and increased risk of neoplasms. Another important patient monitoring parameter for someone on a GLP-1 and a GIP medication is monitoring their blood pressure.

01:28 Now you may think, why do we need to do this? Well, first of all, you want to have a baseline and you want to make sure that you check their blood pressure at each visit because you want to document the trends over time. Hopefully, if the patient has had an elevated blood pressure, you're going to see the blood pressure come down as the patient loses weight.

01:46 So you likely will see gradual improvements with weight loss for some clients.

01:50 So consider adjusting their antihypertensive medications as they lose weight if necessary. Now, what are the red flags for this? What would be some vital signs that require you to take immediate action? Well, if the patient's blood pressure drops so low, they have symptomatic hypotension, meaning it's too low and they are symptomatic with it. Let me explain how that can happen.

02:15 So here's the context.

02:16 While GLP-1 or GIP medications typically lead to modest blood pressure reductions because the patients lost weight, but the other reason is the natural genetic effects.

02:28 Now this will depend on the amount or how fast the changes happen, but usually you'll see these changes are parallel with the weight loss progress.

02:37 Now, natural paretic effects in the context of weight loss refer to this phenomenon.

02:41 So you may not have heard this term, but stick with me.

02:44 This should make sense.

02:45 So when you lose weight, this can lead to an increase in the body's production of these natriuretic peptides.

02:52 Now these are also hormones.

02:55 So people that are losing weight have more of these hormones.

02:59 So what are these hormones do? Well, these natriuretic peptides promote the excretion of sodium.

03:06 Well, you know, anywhere sodium goes, water follows.

03:10 So these peptides promote the body to excrete more sodium.

03:14 And subsequently water follows through the urine.

03:17 So when you have less volume on board that can contribute to lowering the blood pressure and reducing fluid retention.

03:24 So you often see this in individuals who are previously obese.

03:28 So essentially as a patient's weight decreases and their weight loss increases, the body naturally starts to flush out excess sodium through increased natriuretic peptide activity.

03:40 So what are the key points you need to know as a member of the healthcare team? Well when a client has lower natriuretic peptide levels in obesity, studies have shown that people with obesity tend to have lower levels of these peptides compared to individuals with normal weight.

03:58 So if I'm a client who's obese, I already have lower than normal levels of these peptides.

04:05 As I lose weight, though, that's going to increase.

04:08 And that's what acts to flush everything out the sodium and the water. So as they lose weight, their natriuretic peptide levels often increase. And that contributes to the beneficial effects of blood pressure management because they're putting out more sodium and therefore more water. They have less volume in their intravascular space, and less volume in your intravascular space will lead to lower blood pressure.

04:34 So how do you monitor this.

04:36 What should you be keeping an eye on? Well anything the body does well, it can do over well.

04:41 So this client might be at risk for low blood pressure or hypertension.

04:46 Remember that's one of the red flags we'd be looking for.

04:50 Now when is the patient most at risk of this hypertension.

04:54 Well, particularly during the initial titration period.

04:58 And any time they have episodes of really significant dehydration because of the GI side effects they might be feeling.

05:05 And remember, they feel those, particularly during the titration period.

05:10 So what kind of symptoms do you want to educate your patient now would be great if you can get them to be compliant with taking their blood pressure at home.

05:18 That would be a much more accurate number, but these might be some signs that they need to take their blood pressure.

05:25 Like they go from sitting to standing and then ooh, they feel kind of dizzy.

05:30 Or just in walking around, they feel kind of lightheaded, or they may feel really, really tired.

05:35 That kind of fatigue, those would be signals to them.

05:39 That would be a good idea for them to take their blood pressure at home.

05:43 Now, if they have specific orthostatic blood pressure changes, you want to make sure that you follow up in just a little bit different way.

05:50 So you want to check their sitting and standing blood pressure during the initiation of the medication. Now if they have a significant drop I mean greater than 20mm systolic. This requires further evaluation by the healthcare provider. So when you're looking at these orthostatic blood pressure changes and you notice a drop greater than 20mm, they need further evaluation.

06:14 So either you assess this in the office and see if they're okay or need other evaluation.

06:19 But you can also teach your clients to do this at home to be able to give you this information in your communication.

06:25 Now what if the patient is on an antihypertensive, which would not be uncommon for someone who is obese.

06:31 They may have obesity related hypertension, so they would be on medications to treat that. Well, you need specifically they need regular blood pressure monitoring because if they're on anti-hypertensives, we don't want them to go too low because the dose adjustment may need to be made as weight loss occurs.

06:51 So as the patient loses weight, the healthcare provider will need to adjust the dosage or maybe even the type of medication.

06:59 So they'll have to have the discussion if it's time to reduce the antihypertensive medications. If any of these things happen, if the systolic blood pressure is consistently less than 110, time to reconsider.

07:12 If the patient reports hypertensive symptoms, definitely time to reconsider.

07:17 And if the patient develops the orthostatic changes like we just discussed, if those develop, it's time to consider reducing the antihypertensive medications. So let's go through them again.

07:28 If the systolic blood pressure is less than 110, if the patient reports the hypertensive symptoms that you've taught them, or if they experience orthostatic changes if those begin to develop.

07:41 So before you even get started on setting this patient home on the medication, you want to make sure that you have baseline blood pressure documentation before they start the med. And it would be better if you have more than just 1 or 2 measurements. Be much better if you have a trend.

07:56 Now you want them to monitor their blood pressure weekly during the first month of therapy. Then if that's stable, they can do it once a month.

08:04 Now, here's the reasons that you would want more frequent monitoring.

08:08 Remember, if they're on multiple antihypertensive medications, definitely want to monitor their blood pressure more frequently.

08:15 And you should decide through conversation how often that should be.

08:19 What if they have a history of this blood pressure that just goes all up and down? Then yes, they should also monitor their blood pressure more frequently.

08:28 Anytime the client's having significant GI side effects, they need to monitor their blood pressure because we're worried about if they're vomiting or diarrhea, they're losing too much fluid and might really be at risk for hypotension.