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Compounded, Counterfeit Semaglutide Poses Severe Risk to Patients
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Novo Nordisk and Eli Lilly have spoken out against the use of their GLP-1 medications for cosmetic weight loss, emphasizing the proper use of their medications.
It is no secret that the public interest in glucagon-like peptide 1 (GLP-1) agonists has been growing rapidly, with the search popularity for semaglutide (Ozempic; Novo Nordisk) growing exponentially between March 2018 and February 2023, according to an article published in Aesthetic Surgery Journal. Ozempic, according to the authors, remained the most searched medication compared with semaglutide (Wegovy; Novo Nordisk) and tirzepatide (Mounjaro; Eli Lilly) during the same time period.1
The prescriptions of these medications also increased, with Ozempic users increasing from 569 patients in 2019 to 22,891 in 2022. Meanwhile, Wegovy rose from 989 patients in 2021 to 2992 in 2022, according to a study in the Journal of the American Pharmacists Association. The authors stated that the monthly growth rates were 83.9% for Ozempic, 119.2% for Wegovy, and 254.3% for Mounjaro.2
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Ozempic and Rybelsus (Novo Nordisk), a semaglutide tablet, are indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes (T2D), and Ozempic also has an indication to reduce the risk of heart attack, stroke, and death in adults with T2D.3 Wegovy is indicated for individuals with obesity or for those who are overweight with weight-related medical issues, in addition to diet and exercise.3 Most recently, the FDA approved a new indication for Wegovy for the reduction of the risk of cardiovascular death, heart attack, and stroke for patients who have cardiovascular disease and either obesity or overweight.4
Despite these indications, Ozempic, Wegovy, and Mounjaro have been used off-label for cosmetic weight loss. Med spas, in particular, have become a major source of these medications for patients looking to lose weight for cosmetic purposes. Med spas are “a combination of an aesthetic medical center and a day spa,” which can include nonsurgical aesthetic medical services by a licensed physician, according to the American Society of Plastic Surgeons.5 In med spas, common medical interventions include deoxycholic acid (Kybella; Allergan Aesthetics, AbbVie) or semaglutide. Deoxycholic acid is the only fat-dissolving injectable drug that is FDA approved, but it is only approved for fat under the chin, according to the FDA.6 In some cases, the drug has been used in other parts of the body, such as the back, thighs, upper arms, and stomach, but those uses are currently unapproved. The FDA has spoken out against the use of these drugs for unapproved indications, saying this has led to adverse events (AEs).6
Similarly, semaglutide has been used off-label for cosmetic weight loss at med spas. Notably, the drug can be compounded, leading to some compounding-related AEs. Compounded medication does not go through rigorous FDA review for safety, quality, or efficacy, but is allowed under the Federal Food, Drug, and Cosmetic Act when a drug is in shortage. The FDA has reported that some compounds of semaglutide have used salt forms of the drug, which have different active ingredients than the approved formulation. The agency stated that it is not aware of any compounded drugs that could be used in the salt form that would meet the Federal Food, Drug, and Cosmetic Act requirements.3
As of a letter to health care providers in 2023, there were 352 cases of AEs associated with compounded semaglutide, with 268 classified as serious in nature. According to Novo Nordisk, 84 cases required hospitalization and 5 involved deaths. Further, the company stated that some entities have been selling the compounded drug in combination with BPC-157, which the FDA has prohibited in the compounding due to safety risks.7
Furthermore, with regard to impurities, Novo Nordisk has said that the compounded drugs sometimes contain peptide-related impurities that are not found in the FDA-approved formulation, with the level of unknown impurities reaching 33% in some cases. When present, the impurities can lead to serious and life-threatening reactions, including anaphylaxis, according to the letter. Additionally, in some cases, the strength of the compounded samples was lower than the strength specified on the labels.7
Both Eli Lilly and Novo Nordisk have spoken out against the use of their medications for cosmetic weight loss, with Eli Lilly stating that “Mounjaro and Zepbound are indicated for the treatment of serious diseases; they are not approved for—and should not be used for—cosmetic weight loss.”8 Furthermore, Eli Lilly also said in the statement that some products that have claimed to be compounded tirzepatide have contained bacteria, high impurity levels, different chemical structures, and different colors than the approved drugs. They also reported that in one case, the product was nothing more than sugar alcohol.8
In a statement to Pharmacy Times, Novo Nordisk said it is “committed to the responsible use of [the] medicines.” The company stated that compounded products could expose patients to health risks, so patients should be cautious and only use medication with a prescription from a health care provider.
Both companies have taken legal action against med spas, weight loss or medical clinics, and compounding pharmacies for false advertising, trademark infringement, and unlawful sale of non-FDA approved compounded products that claim to contain semaglutide.8 As of March 18, 2024, Novo Nordisk has filed 12 legal actions against these entities. There have been 2 final judgements out of the 12 cases: one against a med spa and one against a weight loss clinic, according to the statement.
In addition to legal action, Eli Lilly has also aired 2 films educating individuals about obesity as a disease and the appropriate use of anti-obesity medications. In the news release, the company stated, “Patient safety is Lilly's top priority, and our medicines are indicated for the treatment of serious diseases. They were not studied for, are not approved for, and should not be used for cosmetic weight loss, and at Lilly, we believe it is important that, in consultation with their health care providers, the right people can get access to these medicines.”9
Eli Lilly did not respond to requests for comment from Pharmacy Times.
References
1. Han SH, Safeek R, Ockerman K, et al. Public Interest in the Off-Label Use of Glucagon-like Peptide 1 Agonists (Ozempic) for Cosmetic Weight Loss: A Google Trends Analysis. Aesthet Surg J. 2023;44(1):60-67. doi:10.1093/asj/sjad211
2. Watanabe JH, Kwon J, Nan B, Reikes A. Trends in glucagon-like peptide 1 receptor agonist use, 2014 to 2022. J Am Pharm Assoc (2003). 2024;64(1):133-138. doi:10.1016/j.japh.2023.10.002
3. FDA. Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss. January 10, 2024. Accessed March 22, 2024. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss
4. Gallagher A. FDA Approves Semaglutide for New Indication Involving Cardiovascular Disease. Pharmacy Times. March 8, 2024. Accessed March 22, 2024. https://www.pharmacytimes.com/view/fda-approves-semaglutide-for-new-indication-involving-cardiovascular-disease
5. Mariotti E. What to look for in a quality med spa. American Society of Plastic Surgeons. March 8, 2019. Accessed March 22, 2024. https://www.plasticsurgery.org/news/blog/what-to-look-for-in-a-quality-med-spa
6. FDA. Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful. December 20, 2023. Accessed March 22, 2024. https://www.fda.gov/drugs/buying-using-medicine-safely/using-fat-dissolving-injections-are-not-fda-approved-can-be-harmful
7. Brett J, Radin M. Compounding Letter. Novo Nordisk. February 2024. Accessed March 22, 2024. https://www.novomedlink.com/content/dam/novomedlink/semaglutide/Compounding-Letter.pdf
8. Open Letter Regarding the Use of Mounjaro (tirzepatide) and Zepbound (tirzepatide). News release. Eli Lilly. March 7, 2024. Accessed March 22, 2024. https://investor.lilly.com/news-releases/news-release-details/open-letter-regarding-use-mounjaror-tirzepatide-and-zepboundr
9. Lilly's Newest Phase of Get Better Campaign Challenges Misperceptions About Obesity Care. News release. Eli Lilly. March 7, 2024. Accessed March 22, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-newest-phase-get-better-campaign-challenges
