FDA Approves Wegovy to Lower Risk for CVD Events in Patients With Obesity
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, March 8, 2024 -- The U.S. Food and Drug Administration has approved Wegovy (semaglutide) for the prevention of myocardial infarction, stroke, and cardiovascular death in patients with obesity or overweight.
In one multinational study involving more than 17,600 people, participants received either injected Wegovy or a placebo injection. All participants also received standard-of-care management of their blood pressure and cholesterol plus counseling on exercise and healthy eating.
"Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack, and stroke), which occurred in 6.5 percent of participants who received Wegovy compared to 8 percent of participants who received placebo," the FDA said.
It is thought that this expanded approval from the FDA could remove barriers from insurance companies when it comes to covering Wegovy. That could greatly expand the number of people who might be prescribed the drug.
Wegovy does have potential side effects, the agency said, including nausea, diarrhea, vomiting, abdominal pain, headache, fatigue, dizziness, hypoglycemia in patients with diabetes, flatulence, and gastroesophageal reflux disease. Patients taking Wegovy may also face increased risks for pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking. Using Wegovy along with insulin also raises risks for hypoglycemia.
"The prescribing information for Wegovy [also] contains a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors," the FDA said, so it should not be used by people with a personal or family history of medullary thyroid carcinoma.
The expanded approval of Wegovy was granted to Novo Nordisk.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted March 2024
Read this next
Use of Fan, Skin Wetting Reduces Cardiac Strain in Hot, Humid Conditions
FRIDAY, Nov. 8, 2024 -- The benefits of fan use, skin wetting, or both on cardiac strain vary with temperature and humidity, according to a study published in the Nov. 7 issue of...
Childhood Body Mass Index Tied to Later Lung Health
FRIDAY, Nov. 8, 2024 -- Childhood body mass index (BMI) is associated with lung health later in life, according to a study published online Oct. 28 in the European...
Health Literacy-Informed Digital Intervention Reduces Obesity at Age 2 Years
FRIDAY, Nov. 8, 2024 -- A health literacy-informed digital intervention reduces the incidence of obesity at 24 months of age, according to a study published online Nov. 3 in the...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.