Ozempic And Thyroid Cancer In Humans

Can Medullary Thyroid Cancer Be Prevented

Many people develop medullary thyroid cancer for no known reason , so prevention isnt possible.

But if you have a family history of MTC and/or multiple endocrine neoplasia type 2 and have tested positive for the RET gene mutation, then you may be able to get preventive surgery to remove your thyroid gland before cancer develops.

At the very least, its important to let your healthcare provider know if you have a family history of MTC and/or so that they can carefully monitor the health of your thyroid.

What To Do If You Take Too Much Ozempic

Call your doctor if you think youve taken too much of this drug. Also, you can call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. However,if your symptoms are severe, call 911 or your local emergency number. Or go to the nearest emergency room right away.

Side Effects And Risks

Ozempic and Trulicity have similar effects in the body and therefore cause very similar side effects. Below are examples of these side effects.

from the FDA about possible risk of thyroid cancer. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

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Important Safety Information For Ozempic

Important Safety Information for Ozempic injection

Warning: Risk of Thyroid C-Cell Tumors

• In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Ozempic will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

• Do not use Ozempic if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 .

What is the FDA-approved use of Ozempic?

Ozempic is a glucagon-like peptide-1 receptor agonist that is used:

• with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

• to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:

• Ozempic has not been studied in patients with a history of pancreatitis.

• Ozempic is not for treatment of type 1 diabetes mellitus.

Your Ro-affiliated provider may recommend the use of Ozempic as treatment for chronic weight management .

Who should not use Ozempic?

Do not use Ozempic if:

How should Ozempic be administered?

What should I tell my Ro-affiliated provider before using Ozempic?

Some medications to watch out for include:

What About Everyone Else

The interesting thing about the risk of MTC and black box warnings on these medications is that there are a couple of unknowns. You see, this black box warning was ultimately put in place based on animal studies, and what researchers found is that when rodents were exposed to GLP-1 RAs such as Ozmepic, the rodents developed MTC. Now interestingly, these results have not been replicated in humans. There were reports of MTC in the landmark trials with GLP-1 RAs such as Victoza. However, the number of cases was very minimal, and cases occurred equally in both the GLP-1 RA and placebo groups. Further analyses that combined the data from multiple studies found a similar result.

I know. Providing you with groundbreaking information rodents and humans are a little different? Stay with me here!

Thankfully, I have a nice little picture below that will hopefully explain this in a lot better detail. Figure A is what happens in rodent cells, and Figure B is in human cells.

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What Other Information Should I Know

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Boxed Warning: Thyroid Cancer Risk

Ozempic has a boxed warning about the possible risk of thyroid cancer. A boxed warning is the most serious warning from the Food and Drug Administration .

Ozempic has caused thyroid cancer in animals. Its unclear if the drug also increases thyroid cancer risk in humans. To lower the potential risk of thyroid cancer, dont use Ozempic if:

• you have a rare genetic condition called multiple endocrine neoplasia type 2
• you or a family member has had medullary thyroid cancer

For more details, see the Side effects explained section above.

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Video Transcript For Ozempic Video

Today, I would like to talk about Ozempic and explain how Ozempic or Semaglutide works, what the effect is and what you can likely expect, the side effects and essentially how to take it and get the best and the most out of it.My name is Dr Sultan Linjawi. I’m a certified Diabetes Specialist and Endocrinologist and this is what I do for a living. I provide education around new diabetes treatments and old diabetes treatments, to people around the world. So let’s talk about Ozempic, or Semaglutide. So Semaglutide is a once weekly injection for people with diabetes. It is something called a GLP1 analogue and I’ll explain a little bit what a GLP-1 is.But in essence it looks very similar to a naturally occurring chemical that we all produce that helps us regulate our appetite as well as our blood sugar levels and this treatment is for people with Type 2 diabetes where it has been tested and investigated fairly heavily. It is not approved for people with Type 1 diabetes and shouldn’t be taken in women who are pregnant or breastfeeding and it is ill-advised at the moment to be using it in children.

Dosage For Type 2 Diabetes

When you first start taking Ozempic, youll take 0.25 mg once weekly for 4 weeks. After this, youll take 0.5 mg once weekly for 4 weeks.

After 4 weeks, if your blood sugar levels are well-controlled, youll continue to take 0.5 mg once weekly. If you need to lower your blood sugar levels even more, your doctor may increase your dosage to 1 or 2 mg once weekly. The maximum recommended dosage of Ozempic is 2 mg once weekly.

You should administer your Ozempic injection on the same day each week. However, you can give the injection at any time of day, with or without meals.

If needed, you can change the day you give your injection. If you do, you must have taken your last dose at least 48 hours before the new day you plan to administer the injection.

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How To Take Ozempic

Before starting Ozempic, read the patient information leaflet with your prescription and ask your healthcare provider or pharmacist any questions.

Make sure to take this medication as directed. People generally start with the lowest dose, which gradually increases as instructed by their healthcare provider. However, you should not change your dose of Ozempic without talking to a healthcare provider.

Ozempic is a subcutaneous injection. This means that it is injected under the skin of the thigh, upper arm, or stomach. People typically inject their dose once a week on the same day each week. A healthcare provider will show you where to inject your dose.

When using Ozempic, remember to:

• Check the solution in the pen before injecting. If the solution is cloudy, has particles in it, or has changed colors, contact your pharmacist for a replacement pen.
• Rotate injection sites. Try not to inject into the same area twice in a row.
• Inject under the skin of the thigh, upper arm, or stomach.

The ingredient in Ozempic, semaglutide, is also available in tablet form under the brand name Rybelsus and as another injection form under the brand name Wegovy. Do not use different kinds of semaglutide at the same time.

What About Weight Loss

We talked about the fact that these drugs are exceptionally impressive at weight reduction and in fact out of all the drugs that we have to date in the GLP1 category Ozempic seems to be the most effective around weight reduction. And if you just look at this graph, anything above the line, is a weight increase.So you can see that in the middle there with the little green mark there around insulin glargine which put on a bit of weight. But across all the other drugs, and the other trials, there was weight reduction and consistently it looks like there was a weight loss of between 3.5kg – 6.5kg favouring Ozempic with the bigger weight loss seen in the higher dose.

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Dosage Forms And Strengths

Injection: clear, colorless solution available in 3 pre-filled, disposable, single-patient-use pens:

Ozempic is contraindicated in patients with:

A personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 .

A serious hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic .

The Uncommon Side Effects

Ok, we are back and again discussing the downsides of some of these anti-obesity medications. We have reviewed the common side effects, but what about the not-so-common side effects? What about the black-box warning regarding a risk of thyroid cancer that the FDA has placed on the class of medications called GLP-1 Receptor Agonists such as Ozempic, Saxenda, Wegovy, etc.?!

When we throw around words such as black box and cancer, our ears tend to perk up and we start paying closer attention, which is excellent! By no means are these things we should take lightly. These checks and balances are in place to ultimately protect people! However, as with anything, we need to look at the picture in its entirety to understand what the evidence says exactly and whether it applies to your given situation or not!

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Monotherapy Use Of Ozempic In Patients With Type 2 Diabetes Mellitus

In a 30-week double-blind trial , 388 patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized to Ozempic 0.5 mg or Ozempic 1 mg once weekly or placebo. Patients had a mean age of 54 years and 54% were men. The mean duration of type 2 diabetes was 4.2 years, and the mean BMI was 33 kg/m2. Overall, 64% were White, 8% were Black or African American, and 21% were Asian 30% identified as Hispanic or Latino ethnicity.

Monotherapy with Ozempic 0.5 mg and 1 mg once weekly for 30 weeks resulted in a statistically significant reduction in HbA1c compared with placebo .

Table 3. Results at Week 30 in a Trial of Ozempic as Monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise

aThe intent-to-treat population includes all randomized and exposed patients. At week 30 the primary HbA1c endpoint was missing for 10%, 7% and 7% of patients and during the trial rescue medication was initiated by 20%, 5% and 4% of patients randomized to placebo, Ozempic 0.5 mg and Ozempic 1 mg, respectively. Missing data were imputed using multiple imputation based on retrieved dropouts.

bIntent-to-treat analysis using ANCOVA adjusted for baseline value and country.

cp< 0.0001 for superiority, adjusted for multiplicity.

Adverse Effects Of Semaglutide

Semantically, the on-target effects of GLP-1RAs are those effects leading to a reduction in glucose levels. Any other effect can be considered as a pleiotropic, off-target effect, or in the case of unwanted actions, adverse effects . Many of the class effects are shared among the different GLP-1RA, however, differences do occur. For semaglutide, one could expect a different side-effect profile for the oral versus the subcutaneous formulation. Apart from the obvioustablets will not induce injection-site reactionsit could be suggested that higher portal levels induce more gastrointestinal disturbances. Moreover, with the maximum oral dosage plasma levels are lower compared with the maximal subcutaneous dose ). Worth noting is that no data comparing the pharmacokinetic profile of both formulations against each other are available. In the following sections, the adverse reactions and safety issues of semaglutide, both oral and subcutaneous, will be discussed. We will discuss the risk of hypoglycemia, gastrointestinal side effects including previous reports on increased risk for pancreatitis and pancreas cancer, thyroid cancer, gallbladder stones, effects on the cardiovascular system, acute kidney injury, diabetic retinopathy risks and allergies/injection-site reactions .

Figure 1 Potential adverse effects associated with GLP1-RAs.

Table 2 Adverse effects and safety risks in phase 3 trials .

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What Are Some Things I Need To Know Or Do While I Take This Drug

For all uses of this drug:

• Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Follow the diet and workout plan that your doctor told you about.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• Kidney problems have happened. Sometimes, these may need to be treated in the hospital or with dialysis.
• If you cannot drink liquids by mouth or if you have upset stomach, throwing up, or diarrhea that does not go away you need to avoid getting dehydrated. Contact your doctor to find out what to do. Dehydration may lead to low blood pressure or to new or worse kidney problems.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• If you are planning on getting pregnant, talk with your doctor. You may need to stop taking this drug at least 2 months before getting pregnant.

If using for high blood sugar:

If using for weight loss:

• If you have high blood sugar , you will need to watch your blood sugar closely.
• Weight loss during pregnancy may cause harm to the unborn baby. If you get pregnant while taking this drug or if you want to get pregnant, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Taking Ozempic With Other Drugs

Your doctor may prescribe Ozempic with other medications to help manage your blood sugar levels or lower your risk of cardiovascular problems.

Some examples of other diabetes medications that may be prescribed with Ozempic include:

If youd like to know more about taking other drugs with Ozempic, talk with your doctor.

Note: For information about things that can interact with Ozempic, such as other drugs or foods, see the What should be considered before taking Ozempic? section below.

Questions for your doctor

You may have questions about Ozempic and your treatment plan. Its important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

• Before your appointment, write down questions like:
• How will Ozempic affect my body, mood, or lifestyle?

Bring someone with you to your appointment if doing so will help you feel more comfortable.

If you dont understand something related to your condition or treatment, ask your doctor to explain it to you.

If youre new to self-injections, ask your doctor to explain the process to you slowly so that you can follow the steps. Until you get the hang of it, dont be shy about asking your doctor to show you the process again.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So, dont be afraid to ask questions or offer feedback on your treatment.

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How Do I Store And/or Throw Out This Drug

Tablets:

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.

Prefilled syringes or pen:

• Store unopened pens in a refrigerator. Do not freeze.
• Do not use if it has been frozen.

Ozempic prefilled pens:

• After opening, store in the refrigerator or at room temperature. Throw away any part not used after 56 days.
• Protect from heat and light.

Wegovy prefilled pens:

• You may store unopened containers at room temperature. If you store at room temperature, throw away any part not used after 28 days.
• Store in the outer carton to protect from light.
• Protect from heat.

All products:

• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.