BELVIQ®BELVIQ® can help you lose weight and improve certain health risk factors
Feel Satisfied When Eating Less
BELVIQ® helps you feel satisfied with less food by targeting a hunger receptor in the brain.
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).
The combined results of these two studies showed that:
- Almost half of people (47.1%) taking BELVIQ® lost 5% or more of their body weight after 1 year of treatment, compared with those using diet and exercise alone (22.6%)
- Some (22.4%) lost as much as 10% of their body weight after 1 year of treatment, compared with those using diet and exercise alone (8.7%)
People taking BELVIQ with diet and exercise had significant improvements in their blood pressure and cholesterol levels, compared to 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 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. All people regained weight but remained below their starting weight.
BELVIQ® helps overweight people with type 2 diabetes lose weight — BELVIQ 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.
*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.
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Important Safety Information
- Pregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant, as weight loss offers no potential benefit during pregnancy and BELVIQ may harm your unborn baby.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
- Valvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor 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, tell your doctor if you have or have had heart problems.
- Changes in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you.
- Mental problems: Taking too much BELVIQ may cause hallucinations, a feeling of being high or in a very good mood, or feelings of standing outside your body.
- Depression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
- Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops.
- Painful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop taking BELVIQ and call your doctor or go to the nearest emergency room right away.
- Slow heartbeat: BELVIQ may cause your heart to beat slower.
- Decreases in blood cell count: BELVIQ may cause your red and white blood cell counts to decrease.
- Increase in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid, or if you are a male and your breasts increase in size.
- Most common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation.
- Most common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue.
- Nursing: BELVIQ should not be taken while breastfeeding.
- Drug interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines, or other medical conditions, such as: triptans; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic); tramadol; dextromethorphan (an over-the-counter (OTC) common cold/cough medicine); OTC supplements such as tryptophan or St. John’s Wort; or erectile dysfunction medicines.
BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence.
For more information about BELVIQ®, talk to your doctor and see full Product Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088
– All Information on this page ©2014 BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH. ©2014 Eisai Inc. BELV1185 11/13 Belviq.