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What has the FDA said about the use of the new obesity drug?

Doctors now have a new tool in the chest to help patients who suffer chronic obesity manage their weight, reducing for some up to 15 percent.

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What has the FDA said about the use of the new obesity drug?
WILLIAM WEST AFP

The Food and Drug Administration (FDA) has given the green light to use Novo Nordisk's diabetes drug semaglutide, under the name Wegovy, for chronic weight management. In clinical trials it was shown to be far more effective than other weight loss drugs on the market causing doctors to call it the new “gold standard”.

Taken on a weekly basis via injection the treatment should be used along with other measures to control weight including exercise and a healthy diet. Wegovy (pronounced wee-GOH'-vee) mimics a naturally occurring hormone that tells the body it is full after a meal as well as slowing digestion. Together the two help curb the appetite of the person receiving the treatment.

Wegovy effective at reducing weight and long-term management

Obesity has been increasing over the years with it now affecting over 40 percent of Americans according to the Centers for Disease Control and Prevention. Even a small reduction in weight can bring health benefits to those who suffer from this chronic and stigmatized health condition which can lead to heart disease, stroke, type 2 diabetes and certain types of cancer. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adult patients with obesity or who are overweight.

In studies funded by the company more than 50% of the participants taking Wegovy lost more than 15% of their body weight over 16 months. By comparison, those receiving the placebo saw an average weight loss of about 2.5%. The study noted that other weight loss medications on the market only achieve an average of 5% to 12% and need to be administered more frequently.

FDA recommendations for using Wegovy

The FDA says that the dosage should be gradually increased over the course of 16 to 20 weeks to the full 2.4mg to reduce gastrointestinal side effects. Nearly 85% of participants in the trials reported experiencing side effects which were mostly mild to moderate which usually subsided. Wegovy's most common side effects, affecting 70% of participants, were gastrointestinal problems, including nausea, diarrhea and vomiting.

Wegovy is not recommended for those with a history of severe allergic reactions to semaglutide or any of the other components of Wegovy. The drug also carries a potential risk for a type of thyroid tumor and shouldn’t be taken by individuals with a personal or family history of certain thyroid and endocrine tumors. Included in the warnings for Wegovy are the risk of pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate and suicidal behavior or thinking.