(RxWiki News) Until this month, the United States had not seen a new weight loss or weight management drug approved since 2014.
The US Food and Drug Administration (FDA) approved Wegovy (semaglutide) injection for chronic weight management.
The FDA approved this drug for adults who are obese or overweight and have at least one weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol. It is approved to be used in combination with diet and exercise.
This new approval is available as an injection to be administered under the skin once a week. The dose is 2.4 mg weekly. However, the dose must be increased gradually to this level over 16 to 20 weeks to reduce the stomach-related side effects.
The active ingredient, semaglutide, is already on the market under two brand names: Ozempic (injection) and Rybelsus (tablets). These two medications are approved to improve sugar control in adults with type 2 diabetes.
"Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said Dr. John Sharretts, deputy director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, in a press release.
Being overweight or obese is linked to heart disease, stroke, diabetes and an increased risk of certain types of cancer.
Wegovy helps manage weight by mimicking a hormone that targets areas in the brain that regulate appetite, according to the FDA.
This medication can lower your blood sugar, so if you are taking insulin or another drug that causes your body to release insulin, speak with your health care provider about how to keep your blood sugar from going too low.
Furthermore, this medication is not to be taken with other weight loss medications. This includes prescriptions, over-the-counter drugs and herbal products.
Some common side effects of Wegovy may include nausea and vomiting, constipation, diarrhea, stomach pain, headache, indigestion, and gas or belching. Serious potential side effects include the risk for pancreatitis, which is the inflammation of the pancreas, as well as gallbladder problems like gallstones.
This drug holds a boxed warning, the most serious type of drug warning, for the potential risk of thyroid C-cell tumors.
This approval was granted to Novo Nordisk.
Speak with your health care provider if you have any questions.