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Important safety information

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Important Safety Information for Wegovy® (semaglutide) Injection

Warning: Risk of Thyroid C-Cell Tumors

Studies in rodents have shown that semaglutide, the active ingredient in Wegovy®, can lead to thyroid tumors, including thyroid cancer. It is unknown if Wegovy® can cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Notify your healthcare provider if you experience symptoms such as a new lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could indicate thyroid cancer.

Who Should Avoid Using Wegovy®

Do not use Wegovy® if you or your family members have a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, avoid Wegovy® if you are allergic to semaglutide.

Wegovy® should not be used with other products containing semaglutide or any other GLP-1 receptor agonists and has not been studied for safety and effectiveness in children under the age of 12.

Avoid using Wegovy® during pregnancy or breastfeeding. It is unclear whether Wegovy® could harm an unborn baby or pass into breast milk. Discontinue Wegovy® at least two months before planning to conceive.

FDA-Approved Use of Wegovy®

Wegovy® is FDA-approved for: Weight management (in conjunction with a reduced calorie diet and exercise) in adults with a body mass index (BMI) of

  • 30 kg/m2 or more (obesity)
  • 27 kg/m2 or more (overweight) with at least one weight-related medical condition (such as high blood pressure, type 2 diabetes, or high cholesterol)

Reducing the risk of major cardiovascular events like heart attack, stroke, or death in adults with known heart disease who are obese or overweight.

Before using Wegovy®, tell your healthcare provider about

All of your medical conditions. Provide your complete medical history, particularly if you are pregnant or planning to become pregnant, are breastfeeding or planning to breastfeed, have any planned surgeries or procedures, or if you have a history of diabetes, thyroid cancer, pancreatitis, ileus, kidney disease, gallstones or diabetic eye disease.

All medications you are taking. Wegovy® causes a delay in stomach emptying, which can impact the absorption of some medications in the stomach. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take, especially any diabetes treatments such as insulin or sulfonylureas.

Wegovy® may cause serious side effects, including:

  • Potential thyroid tumors, including cancer. Notify your healthcare provider if you notice a new lump or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath. These symptoms may indicate thyroid cancer.
  • Inflammation of the pancreas (acute pancreatitis). Stop using Wegovy® and contact your healthcare provider immediately if you experience severe, persistent abdominal pain with or without vomiting, often radiating to the back.
  • Serious allergic reactions. Stop Wegovy® use immediately and seek medical assistance if you experience symptoms like swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.
  • Kidney problems (kidney failure). In individuals with existing kidney issues, dehydration from diarrhea, nausea, or vomiting may worsen kidney function. It is extremely important to maintain adequate fluid intake to reduce dehydration risk.
  • Gallbladder problems. Some individuals using Wegovy® have reported gallbladder issues, including gallstones, which may require surgery. Notify your healthcare provider right away if you experience symptoms such as upper abdominal pain, fever, yellowing of the skin or eyes, or pale-colored stools.
  • Vision changes. Notify your healthcare provider if you notice changes in your vision while using Wegovy®, particularly if you have type 2 diabetes.
  • Low blood sugar (hypoglycemia). Your risk of hypoglycemia may increase if you use Wegovy® with other medications that lower blood sugar, such as sulfonylureas or insulin. Symptoms may include dizziness, blurred vision, anxiety, sweating, confusion, shakiness, weakness, headache, rapid resting heartbeat, and jitteriness.
  • Food or liquid getting to the lungs during surgery. Notify your healthcare provider that you are taking Wegovy® before you are scheduled to have surgery or other procedures.

Common side effects of Wegovy® include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, upset stomach, heartburn, bloating, gas, belching, dizziness, low blood sugar (specifically in people with type 2 diabetes), and runny nose or sore throat.

Consult the complete prescribing information for more details about the safety of Wegovy®. If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.