WEDNESDAY, Dec. 24, 2014 (HealthDay News) -- Saxenda (liraglutide) has been approved by the U.S. Food and Drug Administration to treat chronic obesity.
The injected drug is approved for people with a body mass index (BMI) of 30 or greater, or for those with a BMI of 27 or greater who have at least one other weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol.
BMI is a standard measure of weight-vs-height, with statistical "obesity" beginning at a BMI of 30.
This drug, from a class called "glucagon-peptide receptor agonists," shouldn't be used in combination with other drugs in that class. This includes the diabetes treatment Victoza, which has the same active ingredient at a different dose, the FDA warned in a news release.
Saxenda has not been evaluated to treat diabetes and should not be used for this purpose, the agency added.
The drug's safety and effectiveness were evaluated in three clinical studies involving 4,800 people. In one study, some 62 percent of people who took Saxenda lost at least 5 percent of their body weight, compared with 34 percent who took a placebo, the FDA said.
People who take Saxenda should be evaluated after 16 weeks to determine the treatment's effectiveness. The drug should be discontinued if a user hasn't lost at least 4 percent of body weight during the time span, the agency said.
The drug's label includes a warning that thyroid tumors were observed in rats given Saxenda, although the same effect hasn't been established among people, the FDA said. Potential serious adverse reactions could include pancreatic inflammation, gallbladder disease, kidney impairment, and suicidal thoughts.
More common side effects are nausea, diarrhea, constipation, vomiting, low blood sugar and loss of appetite.
The FDA said it has ordered post-approval studies to evaluate the drug's effects among children, its effects on the heart, central nervous system and potential breast cancer risks, and its effects if taken for at least 15 years.
The drug is produced by Novo Nordisk, based in Denmark.
The FDA has more about this approval.
-- Scott Roberts
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