While the full long-term risk to humans is not yet known, the Black Box Warning exists due to concerning findings in animal studies and a lack of long-term human data

On average, completers achieved 11.5% weight loss vs 7.3% for placebo at 56 weeks 1,3,5 ITT-LOCF: 8.1% weight loss for CONTRAVE and 4.9% for placebo 1 Completers lost an average of 25 lb vs 16 lb for placebo at 56 weeks 5 ITT-LOCF: ~18 lb for CONTRAVE and ~11 lb for placebo 1 There was an average decrease of 4.4 inches in waist circumference for completers vs 3.0 inches for placebo 6 ITT-LOCF: Decrease of 3.9 inches for CONTRAVE and 2.7 inches for placebo 1 In another randomized controlled trial (COR-I) with similar average baseline parameters to those for COR-BMOD, endpoint results over 56 weeks in completers/ITT groups for patients taking CONTRAVE (n=296/538) vs placebo (n=290/536), respectively, were mean weight change from baseline (8.1%/5.4% decrease vs 1.8%/1.3%), patients achieving 5% weight loss (62%/42% vs 23%/17%), and mean change in waist circumference (2.7-inch/2.4-inch decrease vs 1.0 inch/1.0 inch)

GLP-1 receptor agonists like semaglutide and liraglutide intentionally slow gastric emptying as part of their therapeutic mechanism, but distinguishing this expected effect from true gastroparesis presents diagnostic challenges
Produkt jest sklasyfikowany jako odczynnik chemiczny lub materia referencyjny, ktry jest legalnie dopuszczony do obrotu na terenie Unii Europejskiej, ale moe by stosowany wycznie w celach badawczych