What is BELVIQ
BELVIQ is an
FDA-approved prescription weight-loss medication 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 when taken with other
prescription, over-the-counter, or herbal weight-loss products is safe
and effective. 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 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).*
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
*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.
BELVIQ is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic weight
management in adults with an initial body mass index (BMI) of 30 kg/m or greater (obese), or 27 kg/m
or greater (overweight) in the presence of at least one weight-related
comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use: The safety and efficacy of
coadministration of BELVIQ with other products intended for weight loss,
including prescription drugs (eg, phentermine), over-the-counter drugs,
and herbal preparations, have not been established. The effect of
BELVIQ on cardiovascular morbidity and mortality has not been
Important Safety InformationContraindication
- BELVIQ should not be taken during pregnancy or by women who are planning to become pregnant.
Warnings and Precautions
- BELVIQ is a serotonergic drug. The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome
(NMS)-like reactions have been reported during use of serotonergic
drugs, including, but not limited to, selective serotonin-norepinephrine
reuptake inhibitors, and selective serotonin reuptake inhibitors,
tricyclic antidepressants, bupropion, triptans, dietary supplements such
as St. John's Wort and tryptophan, drugs that impair metabolism of
serotonin (including monoamine oxidase inhibitors), dextromethorphan,
lithium, tramadol, antipsychotics or other dopamine antagonists,
particularly when used in combination. Patients should be monitored for
the emergence of serotonin syndrome symptoms or NMS-like reactions,
including agitation, hallucinations, coma, tachycardia, labile blood
pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting,
diarrhea, and muscle rigidity. Treatment with BELVIQ and any
concomitant serotonergic or antidopaminergic agents should be
discontinued immediately if the above events occur, and supportive
symptomatic treatment should be initiated.
- Patients should not take BELVIQ in combination with drugs that
have been associated with valvular heart disease (eg, cabergoline). In
clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients
taking placebo developed valvular regurgitation: none of these patients
were symptomatic. BELVIQ should be used with caution in patients with
congestive heart failure (CHF). Patients who develop signs and symptoms
of valvular heart disease, including dyspnea, dependent edema, CHF, or a
new cardiac murmur, should be evaluated and discontinuation of BELVIQ
should be considered.
- Impairment in attention, memory, somnolence, confusion, and
fatigue have been reported in patients taking BELVIQ. Patients should
not drive a car or operate heavy machinery until they know how BELVIQ
- The recommended dose of 10 mg twice daily should not be
exceeded, as higher doses may cause euphoria, hallucination, and
dissociation. Monitor patients for the development or worsening of
depression, suicidal thoughts or behaviors, and/or any changes in mood.
Discontinue BELVIQ in patients who develop suicidal thoughts or
- Weight loss may increase the risk of hypoglycemia in patients
with type 2 diabetes mellitus who are being treated with antidiabetic
medications, so measurement of blood sugar levels before and during
treatment with BELVIQ is recommended. Decreases in doses of antidiabetic
medications or changes in medication regimen should be considered.
- Men who experience priapism should immediately discontinue
BELVIQ and seek emergency medical attention. BELVIQ should be used with
caution with erectile dysfunction medications. BELVIQ should be used
with caution in men who have conditions that might predispose them to
priapism (eg, sickle cell anemia, multiple myeloma, or leukemia), or in
men with anatomical deformation of the penis (eg, angulation, cavernosal
fibrosis, or Peyronie's disease).
- Because BELVIQ may cause a slow heartbeat, it should be used
with caution in patients with a history of bradycardia or heart block
greater than first degree.
- Consider monitoring for CBC changes, prolactin excess, and pulmonary hypertension.
Most Common Adverse Reactions
- In patients without diabetes: headache (17%), dizziness (9%), fatigue (7%), nausea (8%), dry mouth (5%), and constipation (6%).
- In patients with diabetes: hypoglycemia (29%), headache (15%), back pain (12%), cough (8%), and fatigue (7%).
- BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance that may lead to abuse or dependence.
For more information about BELVIQ, see full Prescribing Information