The U.S. Food and Drug Administration (FDA) has approved Belviq as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of Belviq with other products intended for weight loss and the effect of Belviq on cardiovascular morbidity and mortality have not been established.
Belviq is a prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.
Belviq should be used with a reduced calorie diet and increased physical activity.
It is not known if Belviq is safe and effective when taken with other prescription, over-the- counter, or herbal weight loss products.
It is not known if Belviq changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if Belviq is safe when taken with some other medicines that treat depression, migraines, mental problems, or the common cold (serotonergic or antidopaminergic agents).
It is not known if Belviq is safe and effective in children under 18 years old.
Belviq may cause serious side effects, including:
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions.
Belviq and certain medicines for depression, migraine, the common cold, or other medical problems may affect each other causing serious or life-threatening side effects. Call your doctor right away if you start to have any of the following symptoms while taking Belviq:
- mental changes such as agitation, hallucinations, confusion, or other changes in mental status
- coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
- racing or fast heart beat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity (stiff muscles)
- Valvular heart disease.Some people taking medicines like Belviq have had problems with the valves in their heart. Call your doctor right away if you have any of the following symptoms while taking Belviq:
- trouble breathing
- swelling of the arms, legs, ankles, or feet
- dizziness, fatigue, or weakness that will not go away
- fast or irregular heartbeat
- Changes in your attention or memory.
- Mental problems.Taking Belviq in high doses may cause psychiatric problems such as:
- feeling high or in a very good mood (euphoria)
- feelings of standing next to yourself or out of your body (disassociation)
- Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking Belviq and while you take Belviq.
- Painful erections (priapism). The medicine in Belviq can cause painful erections that last more than 6 hours. If you have an erection lasting more than 4 hours whether it is painful or not, stop using Belviq and call your doctor or go to the nearest emergency room right away.
- Slow heart beat. Belviq may cause your heart to beat slower. Tell your doctor if you have a history of your heart beating slow or heart block.
- Decreases in your blood cell count. Belviq may cause your red and white blood cell count to decrease. Your doctor may do tests to check your blood cell count while you are taking Belviq.
- Increase in prolactin. The medicine in Belviq may increase the amount of a certain hormone your body makes called prolactin. Tell your doctor if your breasts begin to make milk or a milky discharge or if you are a male and your breasts begin to increase in size.
The most common side effects of Belviq include:
- dry mouth
- low blood sugar (hypoglycemia) in patients with diabetes
- back pain
Tell to your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Belviq. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.