Who Should Not Take Semaglutide?

Semaglutide is a medication that triggers the pancreas to release insulin, blocks glucose and slows stomach emptying. It is a glucagon-like peptide-1 agonist (GLP-1) medication, also called a GLP-1 receptor agonist (GLP-1 RA). GLP-1 drugs act like the GLP-1 hormone that occurs naturally in the human body.

The U.S. Food & Drug Administration (FDA) has approved semaglutide for use in different medications:

• In December 2017, it was approved to treat diabetes as the active ingredient in the injectable medication Ozempic®.
• In September 2019, it was approved to treat diabetes in the oral medication Rybelsus®.
• In June 2021, it was approved as an injectable medication to promote weight loss under the brand name Wegovy®.

In recent years, semaglutide’s popularity has exploded.

Semaglutide drug labels mention several groups of people who should avoid taking it. Women who are pregnant, trying to become pregnant or breastfeeding should not take semaglutide. Wegovy is approved for pediatric patients aged 12 and older but not for younger children. Ozempic and Rybelsus should not be taken by anyone under the age of 18.

Keeping the FDA-approved warning labels in mind, patients should not take semaglutide if their personal or family medical histories include any of these issues:

• Clotting issues: Studies show that semaglutide may increase the risk of blood clots in the body’s deep veins by more than 250%. This condition is called deep vein thrombosis (DVT). DVT can be life-threatening if the clot breaks loose, travels through the bloodstream and becomes stuck in the lungs. When this happens, it is called a pulmonary embolism.
• Depression: Some patients have experienced depression and suicidal ideations after using semaglutide. Patients should discuss any history of depression, suicidal thoughts or mental health issues with their doctor.
• Eye diseases: FDA labels list diabetic retinopathy under semaglutide warnings and precautions. The labels advise close monitoring of patients with a history of the condition. Studies also link semaglutide with an increased risk of developing nonarteritic anterior ischemic optic neuropathy (NAION). This condition is caused by inadequate blood flow to the optic nerve, leading to a loss of vision in one or both eyes. It is a significant cause of blindness in adults. You should inform your doctor about previous vision problems before taking semaglutide.
• Gastrointestinal issues: Semaglutide can cause severe stomach problems, including nausea, pain, vomiting, diarrhea and constipation. Semaglutide can also delay stomach emptying. This delayed emptying can lead to gastroparesis, a severe, permanent and life-threatening condition. The drug can also cause intestinal blockage.
• Kidney disease: Semaglutide and pre-existing conditions of the kidneys can make kidney issues worse. Diarrhea and vomiting caused by semaglutide can lead to dehydration. Dehydration can further harm the kidneys and lead to kidney failure.
• Medullary Thyroid Carcinoma (MTC): Semaglutide may cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC). Don’t take Semaglutide if you or anyone in your family has or has had MTC. If you have a history of this condition, your doctor should make you aware of semaglutide side effects and cancer.
• Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2): Patients should not take semaglutide if they or anyone in their family has a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). MEN 2 is a rare genetic condition that causes tumors in the thyroid and parathyroid glands, adrenal glands, lips, mouth, eyes and digestive tract.
• Pancreatic problems: FDA warnings for semaglutide include pancreatitis (inflammation of the pancreas). Inform your healthcare provider about any previous problems with your pancreas before taking the drug. Patients have also reported unlisted side effects like necrotizing pancreatitis and pancreatic cancer.
• Type 1 diabetes: Patients with type 1 diabetes should not use semaglutide as a diabetes treatment or for weight loss.

Semaglutide has several known risks and side effects listed on the FDA warning labels for Ozempic, Rybelsus and Wegovy. Semaglutide side effects may include:

• Acute kidney injury: Patients have submitted several reports to the FDA of acute kidney injury and worsening chronic renal failure. Some of these reports have come from patients with no prior history of kidney disease. Most of these patients also reported nausea, vomiting, diarrhea and dehydration. Doctors should monitor kidney functions in patients with adverse gastrointestinal reactions or a history of kidney problems.
• Acute gallbladder disease: A small percentage of semaglutide users (around 0.5% to 1.5%, depending on the medication) experience some type of acute gallbladder disease. Side effects include gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis). Healthcare providers should do more tests and treatments if they suspect gallbladder problems.
• Aspiration: Though rare, food or liquid can enter the lungs during general anesthesia or deep sedation. This is called pulmonary aspiration, and it can be caused by delayed gastric emptying. Doctors recommend that patients briefly stop taking semaglutide before surgeries or medical procedures.
• Diabetic retinopathy complications: Semaglutide trials show around a 3% to 4% increase in diabetic retinopathy complications, depending on the medication used. This increase jumps to 8.2% in patients with a known history of diabetic retinopathy. No one has studied the long-term side effects semaglutide may have on diabetic retinopathy. Patients with the condition should be monitored.
• Hypersensitivity reactions: Some semaglutide users have reported serious hypersensitivity reactions. These reactions include a severe, life-threatening allergic reaction (anaphylaxis) and swelling and hives (angioedema). Patients with a history of hypersensitivity reactions should use semaglutide with caution.
• Hypoglycemia: Semaglutide can cause hypoglycemia (dangerously low blood sugar) in patients who combine it with insulin or drugs that increase insulin or treat type 2 diabetes (sulfonylurea). Reducing the dose of insulin or insulin secretagogue may avoid this complication. Those who use these medications in combination should be made aware of the risks and signs of hypoglycemia.
• Pancreatitis: Acute and necrotizing pancreatitis has occurred in patients taking semaglutide and other GLP-1 medications. Some users have experienced fatal and non-fatal bleeding around the pancreas (hemorrhagic pancreatitis) and death of part of the pancreas (necrotizing pancreatitis). If doctors suspect pancreatitis, they should advise patients to stop using semaglutide. If the condition is confirmed, patients should not take the medication again.
• Vision changes: A condition linked to semaglutide can cause blindness. The condition is called nonarteritic anterior ischemic optic neuropathy (NAION). NAION is caused by a lack of sufficient blood flow to the optic nerve and can occur in one or both eyes, leading to blindness. The condition is sometimes called eye stroke or eye rot.

Semaglutide black box warnings

A black box warning, or boxed warning, is the most serious warning issued by the FDA. Boxed warnings are usually printed in bold font on a medication’s labeling and inserts.

Semaglutide labels carry a boxed warning alerting patients to the following dangers:

• Thyroid C-cell tumors: Semaglutide has been shown to cause thyroid C-cell tumors in rats. The boxed warning says it is not yet known whether semaglutide causes thyroid C-cell tumors or medullary thyroid carcinoma (MTC) in humans.
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2): Boxed warnings note it is not safe for patients with MEN 2 or a family history of the condition to take semaglutide.

Only a doctor can determine if you meet the semaglutide patient criteria. When you talk to your doctors about whether to take semaglutide, tell them about your personal and family medical history. Your doctor should also tell you about semaglutide and health conditions that may result from the drug.

Some pediatric patients should not take semaglutide. Others who shouldn’t take it are patients who are pregnant, plan to become pregnant or are breastfeeding.

Users should also be aware of the dangers associated with compound semaglutide. Compounded drugs are made by altering, mixing or combining pharmaceutical ingredients. The FDA has received reports of injuries caused by overdoses of compounded semaglutide. Some severe injuries required the patient to be hospitalized.

Patients harmed by compounded semaglutide may not be able to take legal action. Novo Nordisk doesn’t make compounded medications. Injured parties can’t hold the company liable for injuries or illnesses caused by medications it didn’t make.

Follow the semaglutide usage guidelines prescribed to you. Consult your doctor if you experience side effects of the drug, are pregnant or intend to become pregnant. Your healthcare provider can advise you on whether or not to stop taking semaglutide. Never discontinue a medication without first consulting a medical professional.

Motley Rice has helped numerous individuals and their families seek justice for harm caused by dangerous medical drugs and medical devices. We have experience with prescription and over-the-counter medications. We understand the complex legal and scientific aspects of medical drug cases.

If you or someone you love suffered an injury or illness after taking semaglutide, you may have grounds for a lawsuit. We are currently representing clients in litigation involving GLP-1/GLP-1 RA medications, including:

• Ozempic
• Mounjaro®
• Rybelsus
• Saxenda®
• Trulicity®
• Wegovy
• Victoza®

Contact a Motley Rice semaglutide lawyer or call 1.800.768.4026 to discuss your legal rights and options.

Read more on our medical drug litigation experience.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death. Drugs containing semaglutide, including Ozempic, Mounjaro, Rybelsus, Saxenda, Trulicity, Victoza and Wegovy, are still approved by the U.S. Food and Drug Administration.