DiStefano Michael J, Dardouri Mouna, Moore Gina D, Saseen Joseph J, Nair Kavita V
Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Department of Neurology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
J Pharm Policy Pract. 2024 Dec 24;18(1):2441220. doi: 10.1080/20523211.2024.2441220. eCollection 2025.
High prices and other access barriers have contributed to the rise of a market for compounded glucagon-like peptide-1 receptor agonists for weight loss in the United States. This market has not been systematically studied. We conducted a pilot study to assess the prevalence, characteristics, and advertising content of direct-to-consumer providers of compounded glucagon-like peptide-1 products for weight loss in Colorado.
We conducted a cross-sectional study of websites advertising compounded glucagon-like peptide-1 products for weight loss in Colorado. Websites were identified using Google searches focused on census-defined statistical areas. Searches were conducted between March 21 and April 12, 2024. Data collected from websites included physical addresses, business type, highest reported staff credential, advertised glucagon-like peptide-1 products, whether businesses referred to Food and Drug Administration approval when describing products, and whether businesses referred to products as 'generic'.
We identified 93 business websites advertising compounded glucagon-like peptide-1 products for weight loss corresponding to 188 physical locations throughout Colorado. Most businesses were self-categorized as medical/health spas (33/93) or weight loss services (26/93). Advertised products included semaglutide (92/93), tirzepatide (40/93), liraglutide (2/93), and retatrutide (1/93). Advertised combination products included B vitamins (8/93), levocarnitine (1/93), mannitol (1/93), BPC-157 (1/93), and glycine (1/93). Seven websites advertised oral formulations. Additionally, 41/93 websites referred to Food and Drug Administration approval in their descriptions of compounded products and 5/93 referred to products as 'generic'.
This study identified several instances of unapproved glucagon-like peptide-1 products being compounded and advertised in Colorado. Additionally, 1 product was advertised as compounded with BPC-157, a substance determined by the Food and Drug Administration to be unsafe for compounding. This study also identified numerous examples of misleading claims regarding the regulatory status of compounded glucagon-like peptide-1 products. Regulatory action is needed to ensure the benefits of compounded GLP-1 products outweigh the risks.
高昂的价格和其他获取障碍促使美国用于减肥的复方胰高血糖素样肽-1受体激动剂市场兴起。该市场尚未得到系统研究。我们开展了一项试点研究，以评估科罗拉多州直接面向消费者的减肥用复方胰高血糖素样肽-1产品供应商的流行情况、特点及广告内容。
我们对科罗拉多州宣传减肥用复方胰高血糖素样肽-1产品的网站进行了横断面研究。通过谷歌搜索，针对人口普查定义的统计区域来识别网站。搜索于2024年3月21日至4月12日进行。从网站收集的数据包括实际地址、业务类型、报告的最高员工资质、宣传的胰高血糖素样肽-1产品、企业在描述产品时是否提及食品药品监督管理局（FDA）的批准，以及企业是否将产品称为“仿制药”。
我们识别出93个宣传减肥用复方胰高血糖素样肽-1产品的商业网站，对应科罗拉多州各地的188个实际地点。大多数企业将自己归类为医疗/健康水疗中心（33/93）或减肥服务机构（26/93）。宣传的产品包括司美格鲁肽（92/93）、替尔泊肽（40/93）、利拉鲁肽（2/93）和retatrutide（1/93）。宣传的复方产品包括维生素B（8/93）、左卡尼汀（1/93）、甘露醇（1/93）、BPC-157（1/93）和甘氨酸（1/93）。7个网站宣传口服制剂。此外，41/93的网站在其对复方产品的描述中提及了FDA的批准，5/93的网站将产品称为“仿制药”。
本研究发现科罗拉多州有几起未经批准的胰高血糖素样肽-1产品被配制和宣传的情况。此外，有1种产品宣传为与BPC-157混合，BPC-157是一种被FDA认定为不安全用于配制的物质。本研究还发现了许多关于复方胰高血糖素样肽-1产品监管状态的误导性声明的例子。需要采取监管行动以确保复方GLP-1产品的益处大于风险。
