However, a new request by Ozempic manufacturer Novo Nordisk could limit the availability of a type of GLP-1—semaglutides—to local clinics and pharmacies. This shift comes amid safety concerns regarding compounded versions of the drugs and could cause price increases, medical professionals say.
“A large concern is the lack of evidence for safety and efficacy of these compounded versions,” said Dr. Deborah Horn, director of obesity medicine at UTHealth Houston.
The U.S. Food and Drug Administration reports there can be several side effects of GLP-1 drugs, including:
- Nausea/vomiting
- Diarrhea
- Abdominal pain
- Constipation
The demand for GLP-1 drugs jumped 300% since the FDA approved Ozempic in 2017, per reports from health care analytics company Trilliant Health. Ozempic and WeGovy were added to the list of drug shortages by the FDA in March 2022, and are still listed as “currently in shortage” as of publication.
“If placed on the list, patients taking compounded GLP-1 Semaglutide would likely no longer be able to obtain it and would need to revert to Wegovy, brand name semaglutide for obesity,” Horn said. “Patented semaglutide is more expensive than compounded medication and so many patients may find themselves no longer able to afford the medication.”
“Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them,” Althoff said. “Our nomination provides numerous examples of these risks, including unknown impurities, peptide-related impurities, incorrect strengths and even instances where no semaglutide was present in the product at all.”
By the numbers
According to the Kaiser Family Foundation and the FDA:
- One in eight adults have used GLP-1 drugs to lose weight or treat a chronic condition—such as diabetes or heart disease.
- $10.7 billion was spent nationally on semaglutides in 2021.
- 22% of adults who have taken GLP-1 drugs received them from an online provider, website, medical spa or aesthetic medical center.
- 392 reports of adverse events with compounded semaglutide have been reported to the FDA in 2024.
Dr. Brandon Fadner, a bariatric surgeon and medical director at the Center for Metabolic & Bariatric Surgery at St. Luke’s Health - Sugar Land Hospital, said he supports patients using both bariatric surgeries and GLP-1 treatments to treat obesity and manage their metabolic hormones.
“These medicines are not going to be a replacement but an adjunct and a tool in the obesity doctors’ ... [toolbox] at treating this disease process,” he said.
However, Fadner said a shortage of GLP-1 treatments and insurance challenges opened the door for compounded pharmacies, which he described as the “wild west,” as not all are FDA-approved.
Meanwhile, Dr. Tyler J. Varisco, assistant director at the University of Houston’s College of Pharmacy, expressed concerns the widespread availability of compounded semaglutide has reduced the amount of available products for those struggling with diabetes and other weight loss issues.
“Health equity is important, and we want these drugs to be available to people who actually need them,” Varisco said.
What they're saying
- “At the end of the day, we have the public health to worry about, and I think access will remain ... important,” Varisco said.
- “These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits,” Althoff said.
The average cost of GLP-1 drugs ranges from $936-$1,023 for a one-month supply before insurance, according to the Kaiser Family Foundation. However, Horn said the production of compounded versions of semaglutides provides affordable access.
“If the compounding pharmacies could demonstrate the efficacy and safety to the FDA, I would welcome the scenario as it would force the price of the patented drugs to come down,” Horn said.
Fadner said it’s important for patients to discuss the risks and efficacies of semaglutide and bariatric surgeries with their physician before beginning treatment. Over a 12- to 18-month period:
- Semaglutide can result in a 15%-18% total body weight loss
- Tirzepatide can reduce weight 20%-22%
- Bariatric surgeries can reduce weight over 30%
Because of this, Fadner said he believes there will be a rebound in bariatric surgeries.
“[Bariatric surgery] volumes have decreased nationwide for now, but these medicines are very new, and they seem to be capping out,” he said.
The FDA has yet to issue a decision on the restriction of compounding semaglutides, but has released guidelines, which include the prohibition of salt-based semaglutides and Retatrutide, another compound the FDA found used in some medications.
Sugar Land Medical Spa provides clients a compounded semaglutide from two FDA-approved compound pharmacies in the Houston area, founder Dr. Kimberly Evans said.
Novo Nordisk’s request, if approved, would make it difficult for patients to access a more affordable version of the medication, Evans said.
“I understand why they’re trying to restrict it, but I don’t think personally that that’s a good thing for our overall community, our overall U.S. economy in general and then, certainly, it’s just not good for the patient [or] consumer,” she said.
