BELVIQ, 10 mg twice daily, can help you lose weight and improve certain health risk factors. In FDA clinical trials, people who added BELVIQ to diet and exercise were able to lose weight and improve health risk factors, such as high blood pressure, high blood sugar, and high cholesterol levels. BELVIQ was tested in two major clinical studies, one lasting a year (4,008 people) and one lasting 2 years (3,182 people).* Though it is not a blood pressure treatment, BELVIQ may lower blood pressure.
The combined results of these two studies showed that:
People taking BELVIQ with diet and exercise had significant improvements in their blood pressure and cholesterol levels, compared with those using diet and exercise alone. It is not known if BELVIQ changes your risk of heart problems, stroke, or death due to heart problems or stroke.
BELVIQ® can help you manage your weight loss — In a major clinical trial, people taking BELVIQ
10 mg twice daily were able to lose weight and maintain weight loss up to 2 years. In the 2-year study, almost half of people who completed the first year continued on in year 2. Patients in all groups who completed the study regained weight but remained below their starting weight.
BELVIQ® helps overweight people with type 2 diabetes lose weight — BELVIQ 10 mg twice daily was also tested in a study involving 604* overweight men and women with type 2 diabetes. Results showed that more than a third of people taking BELVIQ with diet and exercise (37.5%) lost 5% or more of their body weight, compared with those using diet and exercise alone (16.1%). In the same study, the BELVIQ group showed significant improvements in blood sugar levels, compared with those using diet and exercise alone.
The most common side affects for BELVIQ were headache, dizziness, fatigue, nausea, dry mouth, constipation, low blood sugar (in patients with type 2 diabetes), and back pain.
*Nearly half of all participants completed the studies in overweight patients without diabetes; nearly two-thirds of the participants completed the study in overweight patients with diabetes.
Once-Daily BELVIQ XR® provides support throughout the day. Each 20 mg orange-colored tablet releases medicine in your body throughout the day. The approval of Once-Daily BELVIQ XR® 20 mg extended-release tablet is based on the results of a clinical study which found this formulation to be bioequivalent (i.e., performs in the same manner) to the twice-daily BELVIQ® 10 mg immediate-release tablet.
The bioequivalence and bioavailability of Once-Daily BELVIQ XR 20 mg compared with twice-daily BELVIQ 10 mg was based on a Phase 1 registrational clinical trials among healthy adult subjects. Bioequivalence was demonstrated between BELVIQ XR and BELVIQ.
Valvular heart disease: Some people taking medicines like BELVIQ or BELVIQ XR have had heart valve problems. Call your Healthcare Provider right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ or BELVIQ XR, tell your Healthcare Provider if you have or have had heart problems.
Please see additional Important Safety Information below for BELVIQ® and BELVIQ XR®.
BELVIQ® and BELVIQ XR® are FDA-approved prescription weight-loss medications that, when used with diet and exercise, can help some overweight (Body Mass Index (BMI) ≥27 kg/m2) adults with a weight-related medical problem, or obese (BMI ≥30 kg/m2) adults, lose weight and keep it off.
It is not known if BELVIQ or BELVIQ XR when taken with other prescription, over-the-counter, or herbal weight-loss products is safe and effective. It is not known if BELVIQ or BELVIQ XR changes your risk of heart problems, stroke, or death due to heart problems or stroke.
BELVIQ and BELVIQ XR are federally controlled substances (CIV) because they may be abused or lead to drug dependence.
For more information about BELVIQ® and BELVIQ XR® talk to your Healthcare Provider and see the full Product Information for BELVIQ®, BELVIQ XR®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or