‘Real-time Experiment’: Compounded GLP-1s on Coupon Site

‘Real-time Experiment’: Compounded GLP-1s on Coupon Site

With demand continuing to skyrocket for the glucagon-like peptide 1 (GLP-1) agonists semaglutide and dual GLP-1/glucose-dependent insulinotropic polypeptide tirzepatide, compounded versions of the medications are being promoted on Groupon, an online coupon platform known for deals on restaurant meals, spa services, travel, and consumer goods.

But the development has not pleased some obesity specialists and consumer watchdog groups. The US Food and Drug Administration (FDA) has warned consumers compounded versions of semaglutide “may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations.” Those salt-based versions “have not been shown to be safe and effective,” said the FDA. Novo Nordisk, the manufacturer of semaglutide (Wegovy for weight loss; Ozempic for type 2 diabetes), has sued some compounding pharmacies in Florida, saying their versions of semaglutide were impure.

“What I’m hearing is extremely unfortunate,” 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 said she wasn’t aware of the Groupon offers. “It’s very disturbing to me. I can’t believe it actually.”

Apovian said that she does not prescribe compounded semaglutide because she is not convinced of its safety or effectiveness, but that she’s also concerned about a lack of a patient relationship with the online prescribers.

Obesity “is a serious disease,” she said. “And these medications have side effects,” said Apovian, a professor of medicine at Harvard Medical School, Boston, Massachusetts. The GLP-1 agonists should only “be prescribed by a doctor who knows what they’re doing, who is a primary care provider, or someone who knows how to treat obesity — not by a physician’s assistant or nurse practitioner or even a doctor who’s just interested in prescribing a medication through telemedicine without seeing or touching a patient.”

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said that until advised of such by Medscape Medical News, he had not previously heard of any companies advertising semaglutide on Groupon. He said most compounding pharmacies don’t advertise that they compound GLP-1 agonists. “Most don’t need to; they’ve got relationships with physicians who are seeing patients and prescribing these drugs the old-fashioned way,” Brunner told Medscape Medical News.

At press time in late December 2023, many of the top-trending offers on Groupon were for semaglutide, such as a 6-week program from bmiMD.com that included the medication and a telehealth consultation with a physician for $59 with a special pre-Christmas promotion. The service was marked down three times, from $999 to $69, then to $62.10, and finally to $59.

Among the dozens of other offers: WeightCare’s 6-week program, which included a 2.5-mg vial of semaglutide along with a telemedicine consultation and “unlimited follow-up messaging with your doctor” for $64.98 using the special promotion.

Fewer companies advertised for tirzepatide, and the discounts were not as steep. An offer from Miami-based CLP Med Spa’s included a consultation that would recommend “a healthy eating plan and exercise” and compounded tirzepatide for $50 a week, with a 4-week minimum. According to the offer, “Groupon customers that continue their tirzepatide weight reduction program with CLP Med Spa will enjoy a discounted weekly charge of $110/week (Reg. $185/wk).” They also must pay a $65 consultation fee for every refill.

Champion Health and Wellness Clinics, which promises that “eligible Members Lose 53+ lbs over 4-6 months with Diet and Exercise,” was pitching a 2-month supply of tirzepatide for $597.64 with a special promotion.

Compounding Raises Concerns

An FDA spokesperson told Medscape Medical News in mid-December 2023 the agency had received more than 95 reports of adverse events linked to compounded semaglutide as of October 27, 2023. Some of those adverse events were consistent with what is included on the labels for semaglutide products, said the spokesperson, but “the FDA is unable to determine how or if other factors, such as differences in ingredients and formulation between FDA-approved and compounded semaglutide products, may have contributed.”

Consumer watchdog Public Citizen said it does not support compounded semaglutide being marketed through platforms like Groupon and has general concerns about compounded medications.

“Our view is that patients should not use a compounded drug if an approved drug is available,” Robert Steinbrook, MD, director of the Public Citizen Health Research Group, told Medscape Medical News.

Federal law allows for compounding of FDA-approved drugs when they are in shortage, according to the Alliance for Pharmacy Compounding.

Brunner pushed back against the idea that compounding in and of itself creates an unsafe or ineffective product. “Because compounded semaglutide is a sterile injectable, the laws, regulations, and standards with which a compounding pharmacy must comply are automatically higher than those for nonsterile compounding,” he told Medscape Medical News.

An Alliance fact sheet said it is concerned, however, about consumers buying “substances purporting to be semaglutide from unregulated, unlicensed online sources without a prescription. That’s not compounding. Those aren’t even pharmacies — and claims about those substances cannot be substantiated or trusted.”

Semaglutide continues to be in short supply in some dosage strengths. Its manufacturer, Novo Nordisk, said in mid-December 2023 demand continued to outpace supply of the 1.7-mg dose (typically the fourth dose as patients titrate up), but it had ample supplies of the 2.4-mg maintenance dose. The company is shipping only the two lower-dose strengths to US wholesalers, who are distributing to retail pharmacies. Novo said it anticipates “ongoing supply disruptions in the United States, resulting in some patients having difficulty filling their Wegovy prescriptions.”

Tirzepatide — sold by Eli Lilly as Mounjaro for type 2 diabetes — has occasionally been in short supply in the United States, but the Zepbound injectable for weight loss, which was FDA-approved in November, is not in shortage.

Danger With no Physician Relationship

Apovian said some of her patients taking the brand name products had experienced serious side effects associated with the medications, such as paralytic ileus. “Even when monitored by the best doctors in the country for obesity medicine, you can get serious side effects,” Apovian said.

Some prospective patients — because of the 12-month waiting list to get into the Brigham and Women’s clinic — have obtained compounded versions of the drugs, Apovian said.

One such patient lost 100 pounds on compounded tirzepatide, she said. Without physician supervision, the woman now has a body mass index of 19 and told Apovian she’s hoarding supplies and dosing herself every 20 days. Malnutrition is now a concern. “She probably has an eating disorder and looks like a patient with anorexia,” said Apovian. “This is what can happen without close monitoring,” she said, adding, “it is not good.”

GLP-1 agonists “are best prescribed by a clinician, after a full discussion of the benefits and risks,” Steinbrook said. He called GLP-1 agonists for weight loss “a real-time experiment.”

With any medication, “if side effects are going to emerge, it’s in the first 1-7 years,” after marketing, he said.

“We’d like to see consumers step up and make wise choices,” Steinbrook said. “We’d like the FDA to be proactive and exercise its regulatory authority when it can, when it’s consistent with the authority that it has and also to use the bully pulpit.”

Apovian reported that she has participated on advisory boards for Altimmune, Inc.; CinFina Pharma, Inc.; Cowen and Company; LLC; EPG Communication Holdings Ltd.; Form Health, Inc.; Gelesis, Srl.; L-Nutra, Inc.; NeuroBo Pharmaceuticals, Inc.; Novo Nordisk, Inc.; OptumRx, Inc.; Pain Script Corporation; Palatin Technologies, Inc.; Pursuit By You; ReShape Lifesciences, Inc.; Riverview School; Roman Health Ventures, Inc.; and Xeno Biosciences. She has received research funding from the NIH, PCORI, and GI Dynamics, Inc.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on X (formerly known as Twitter): @aliciaault.

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