Weight-Loss Injection Receives FDA Approval as the First Treatment to Reduce Heart Problem Risk

On March 8, 2024, the US Food and Drug Administration (FDA) approved a new indication for adults with cardiovascular disease and obesity or overweight, to reduce cardiovascular death, heart attack and stroke risk using Wegovy, containing semaglutide (Novo Nordisk), an injection. It should be used with a reduced-calorie diet and increased physical activity. Cardiovascular disease refers to diseases of the heart and blood vessels.

Known worldwide as a weight-loss injection, Wegovy is now the first weight-loss drug approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and obesity or overweight. These patients face greater cardiovascular death, heart attack and stroke risk. A treatment proven to lower this risk represents a major public health advance.

Obesity or overweight affects more than 50% of adults in Middle Eastern and Western societies. These serious conditions increase premature death and various health problems, including heart attack and stroke.

Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It should not be combined with other semaglutide-containing products or other GLP-1 receptor agonists.

The Clinical Trial Supporting Approval

Efficacy and safety for the new indication were assessed in a multinational, multicenter, placebo-controlled, double-blind trial randomizing more than 17,600 participants to Wegovy or placebo. Both groups also received standard medical care, such as blood pressure and cholesterol management, and healthy-lifestyle counseling on diet and activity. Wegovy significantly reduced major adverse cardiovascular events—cardiovascular death, heart attack and stroke—which occurred in 6.5% receiving Wegovy and 8% receiving placebo.

Wegovy's prescribing information carries a boxed warning about thyroid C-cell tumor risk. It should not be used in patients with a personal or family history of medullary thyroid carcinoma or the rare condition multiple endocrine neoplasia syndrome type 2.

It should not be used in patients with previous severe allergic reactions to semaglutide or other ingredients. If a serious reaction is suspected, patients should stop Wegovy immediately and seek medical help.

Warnings also cover pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy (retinal damage), increased heart rate and suicidal behavior or thoughts. Patients should contact their healthcare provider about symptoms of pancreatitis or gallstones. If Wegovy is combined with insulin or an insulin-releasing medicine, they should discuss hypoglycemia risk. Healthcare professionals should monitor kidney disease, diabetic retinopathy, depression and suicidal behavior or thoughts.

Common adverse effects include nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal bloating, belching, hypoglycemia (low blood sugar) in people with diabetes, gas and gastroesophageal reflux disease (heartburn).

Weight-Loss Injections Were the World's Most Discussed Medicines in 2023

The January 2023 approval of the GLP-1 receptor agonist semaglutide for weight management marked a new era in obesity treatment. In recent months, however, regulators have documented rare, sometimes serious adverse effects associated with using these agents for diabetes. Some doctors may be unaware of them.

The following FDA-approved medicines are used as weight-loss injections: