The medication can now be marketed as the first obesity treatment that reduces the risk of major cardiovascular events like heart attacks, strokes, and cardiovascular deaths in obese or overweight people.
In addition to aiding weight loss, the semaglutide medication, which falls in a class of drugs known as GLP-1 receptor agonists, can now be prescribed alongside a reduced-calorie diet and increased physical activity to manage heart health issues and lower cardiovascular disease risk, per the FDA’s approval.
Label Updated Following Successful Studies
The FDA approved Wegovy for treating cardiovascular disease based on a large multinational, multicenter, placebo-controlled, double-blind trial. The trial, published in the New England Journal of Medicine, involved over 17,600 participants who received either semaglutide or a placebo, in addition to standard care like blood pressure and cholesterol management, and lifestyle counseling for diet and exercise.In the study, 6.5 percent of participants taking semaglutide experienced adverse cardiovascular events, compared to 8 percent in the placebo group.
Wegovy Carries Serious Safety Warnings
While studies and celebrity endorsements suggest Wegovy could benefit many Americans, the medication comes with several warnings.The FDA has issued a boxed warning about the risk of thyroid C-cell tumors, which although rare, can grow uncontrollably, according to the National Cancer Institute. People with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia (MEN) syndrome type 2, a condition that can potentially cause tumors in the thyroid, parathyroid glands, adrenal glands, lips, mouth, eyes, and digestive tract, should not take Wegovy.
The FDA also notes that individuals with a history of severe allergic reaction to semaglutide should avoid Wegovy, as that is the main ingredient in the medication.
The FDA also cautions against using Wegovy for those with a history of severe allergic reactions to semaglutide, the drug’s active ingredient. Additional warnings include risks of pancreatitis, gallbladder issues, hypoglycemia, acute kidney injury, hypersensitivity reactions, retinal damage, increased heart rate, and suicidal thoughts or behavior.
