In Three Phase 3 Clinical Trials, All Patients Were Evaluated for Valvular Heart Disease1
- The 5-HT2B receptor has been associated with valvular heart disease. When used at the approved dose, BELVIQ selectively interacts with 5-HT2C receptors as compared with 5-HT2B receptors
- Incidence of FDA-defined valvular regurgitation*:
- 2.4% with BELVIQ vs 2.0% with placebo
- None of these patients were symptomatic
- Pooled relative risk of FDA-defined valvulopathy* at Week 52:
- 1.16 (95% CI, 0.81, 1.67) for BELVIQ vs placebo
- Patients who develop signs or symptoms of valvular heart disease, including dyspnea, dependent edema, congestive heart failure, or a new cardiac murmur while being treated with BELVIQ should be evaluated and discontinuation of BELVIQ should be considered.
- Patients should not take BELVIQ in combination with potent 5-HT2B receptor agonists that have been associated with regurgitant valvular heart disease (e.g., 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.
- 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, signs and symptoms of prolactin excess, and pulmonary hypertension.
- The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
*Mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation.