As the demand for the glucagon-like peptide-1 (GLP-1) agonists semaglutide and the dual GLP-1/glucose-dependent insulinotropic polypeptide tirzepatide continues to skyrocket, compounded versions of the medications are being promoted on Groupon, an online coupon platform known for its offers on restaurant meals, wellness services, travel, and consumer goods.
However, this development has not pleased some obesity specialists and consumer advocacy groups. The U.S. Food and Drug Administration (FDA) has warned consumers that compounded versions of semaglutide „may not contain the same active ingredient as FDA-approved semaglutide products and may contain salt formulations.“ These salt-based versions „have not been proven to be safe and effective,“ according to the FDA. Novo Nordisk, the manufacturer of semaglutide (Wegovy for weight loss, Ozempic for type 2 diabetes treatment), has filed lawsuits against some drug pharmacies in Florida, claiming their versions of semaglutide are impure.
„What I’m hearing is extremely distressing,“ said Caroline M. Apovian, MD, Co-Director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston, Massachusetts. Apovian stated that she was unaware of the Groupon offers and expressed her concern about the lack of patient-doctor relationship with the online prescribers.
Obesity „is a serious disease,“ she said. „And these drugs have side effects,“ said Apovian, a professor of medicine at Harvard Medical School in Boston, Massachusetts. GLP-1 agonists should only be „prescribed by a doctor who knows what they’re doing, who is a primary care physician, or someone who is knowledgeable about treating obesity – not just by a medical assistant or a nurse, or even by a doctor who is not really just interested in prescribing a medicine via telemedicine without seeing or touching a patient.“
According to Scott Brunner, CEO of the Alliance for Pharmacy Compounding, until he was informed by Medscape Medical News, he had not previously heard of companies advertising semaglutide on Groupon. He stated that most pharmacies do not need to advertise that they compound GLP-1 agonists. „Most don’t need to; they have relationships with physicians who treat patients and prescribe these medications in the old-fashioned way,“ he said to Medscape Medical News.
At the time of writing in late December 2023, many of the trending offers on Groupon involved semaglutide, such as a 6-week program from bmiMD.com that included the medication and telemedicine consultation with a doctor for $59 as part of a special pre-Christmas promotion. Less companies were advertising tirzepatide, and the discounts were not as high.
The FDA received over 95 reports of adverse events related to compounded semaglutide by October 27, 2023. These events included some that matched the labels for semaglutide products, but the FDA could not determine the contribution of other factors, such as differences in ingredients and formulations, between FDA-approved and compounded semaglutide products.
Apovian reported that some of her patients experienced serious side effects related to medications, including a paralytic ileus. „Even with the best obesity medicine doctors in the country, serious side effects can occur,“ she said.
„It’s best for GLP-1 agonists to be prescribed by a doctor after discussing the benefits and risks in depth,“ said Dr. Robert Steinbrook, Director of the Public Citizen Health Research Group. „GLP-1 agonists for weight loss are a real-time experiment,“ he said.
The availability of semaglutide in some dosage strengths continues to be scarce. Novo Nordisk, the manufacturer, announced in mid-December 2023 that the demand for the 1.7 mg dosage of semaglutide continues to exceed supply, leading to ongoing supply disruptions in the United States.
Tirzepatide, sold by Eli Lilly as Mounjaro for type 2 diabetes treatment, has occasionally been in short supply in the United States, but the injectable weight loss drug Zepbound was approved by the FDA in November and is not scarce.
Ault reported receiving funding from NIH, PCORI, and GI Dynamics, Inc.