Bonnie Lange found herself in a tough spot when her insurance decided not to cover Wegovy, a weight loss medication. With the out-of-pocket price exceeding $1,300 monthly, she needed to find another option.

Ultimately, she opted for a compounded form of semaglutide, the same active ingredient present in Wegovy and Ozempic, although this version hasn’t been approved by the U.S. Food and Drug Administration (FDA).

The 59-year-old resident of Columbus, Ohio, shared that obtaining these medications online was quite straightforward. With so many companies available, all she had to do was fill out a questionnaire and have a phone consultation with a telehealth provider. While she experienced some mild side effects like nausea, she successfully lost 12 pounds in just one month.

“It’s been a positive experience overall,” Lange remarked, stating she spends about $200 per month on her prescription, which she plans to use for a year.

Many others, like Lange, report success with compounded drugs, finding them to be a more affordable and accessible alternative during the shortage of brand-name options. However, various health experts are expressing concerns about the potential risks of using these alternative medications.

What Exactly is Compounded Semaglutide?

In cases of shortages of FDA-approved medications like Ozempic and Wegovy, the FDA permits compounding pharmacies to create alternative medications that are essentially replicas of the brand-name drugs, containing the same active ingredient—semaglutide, which suppresses appetite. While these pharmacies are typically regulated by state pharmacy boards and draw their ingredients from FDA-registered facilities, the FDA does not evaluate the safety, effectiveness, or quality of the compounded medications.

According to Novo Nordisk, the producer of Ozempic and Wegovy, the company does not supply bulk semaglutide to compounding pharmacies. In January, the FDA reported that some compounding drugs were made using salt forms of semaglutide, which differ from the formulation used in FDA-approved weight loss medications.

While certain compounding pharmacies may be reputable, Dr. Diana Thiara, medical director at the University of California, San Francisco’s weight management clinic, warns that there is no assurance that they adhere to the same strict safety standards as approved drugs.

“We advise against compounding for patients due to safety concerns,” Thiara cautioned.

The FDA has recorded over 31,000 reports of adverse effects potentially linked to semaglutide products as of July 15. Of these, more than 280 were attributed to compounded versions, though this number might not represent the full scope because some patients might not recognize that their medication is compounded.

Another issue is the accessibility of these drugs. Although some online providers demand a consultation, obtaining a GLP-1 prescription might not always require verifying body mass index or lab tests, making it easier for individuals to potentially misrepresent their health status, according to Thiara.

“There’s nothing stringent to validate that this medication is genuinely necessary for an individual,” she added.

Additionally, not every online pharmacy is compliant with the law. The National Association of Boards of Pharmacy has identified over 40,000 online pharmacies that fail to meet safety standards or legal requirements.

Novo Nordisk has reported instances of compounded medications containing impurities or lacking semaglutide altogether, and the company has initiated multiple lawsuits to halt unauthorized sales of these compounded drugs by medical spas, weight loss clinics, and pharmacies.

Nevertheless, some legal compounding pharmacies provide essential alternative medications during the shortage of brand-name drugs.

Experts assert that FDA-approved drugs should be prioritized if available, yet compounded drugs can serve as a safer alternative and should not be confused with illegal counterfeits, according to Tenille Davis, chief advocacy officer for the Alliance for Pharmacy Compounding.

As long as patients receive prescriptions from qualified medical practitioners and obtain their medications from legitimate compounding pharmacies, “regulatory measures are in place to ensure maximum safety,” Davis stated.

Davis also advises checking state Board of Pharmacy websites to verify the licensing of a compounding pharmacy. The FDA’s website provides resources for locating legitimate online pharmacies.

Are there risks of overdosing?

Unlike Ozempic and Wegovy, which are delivered in prefilled pens, compounded semaglutides are typically provided in vials that patients fill on their own. Earlier this year, the FDA warned about potential dosing mistakes that could lead to “adverse events, some of which necessitate hospitalization.”

By June 30, there had been 159 reports to U.S. poison control centers regarding compounded GLP-1s, according to America’s Poison Centers. This figure represents approximately 4% of the 3,866 calls related to all GLP-1 drugs during that period. This number has increased from just 32 compounded GLP-1 exposure calls throughout all of 2023.

“Many of these incidents are linked to individuals attempting to use the drug therapeutically but making mistakes in how they administer it,” explained Kait Brown, clinical managing director of America’s Poison Centers.

Brand-name weight management medications can induce nausea and gastrointestinal issues, and an overdose on compounded semaglutide may result in similar or even more severe symptoms, including nausea, vomiting, faintness, dehydration, acute pancreatitis, and gallstones, as warned by the FDA.

As the drug typically takes about a week to reduce by half in the body, side effects from an overdose may persist for some time.

“If you take an excessive amount and start to feel very nauseous or vomit, those symptoms can linger,” Thiara pointed out.

Lange, a former medical assistant, mentioned that even she found it challenging to measure her first dose using Hims & Hers, a telehealth service that originally focused on medications for erectile dysfunction and hair loss. She was able to resolve her confusion after contacting customer support.

According to Hims & Hers Chief Medical Officer Pat Carroll, the company provides educational materials and has a support team available every day to assist patients in ensuring they take the appropriate dosage. He described the intake process as “comprehensive,” which differs based on the state the patient is in but usually involves a questionnaire with up to 100 queries, reviewed by a licensed professional, and sometimes a video consultation.

“There remains a significant challenge regarding the affordability and accessibility of these medications, and having high-quality compounded alternatives available through platforms like ours is crucial for providing affordable access,” Carroll remarked.

Since announcing the introduction of compounded semaglutide in May, the company has experienced a 52% increase in quarterly revenue compared to the previous year.

Ro, another well-known telehealth platform, requires patients to fill out a medical history and goals questionnaire and to either provide a photo or have a virtual visit. A healthcare provider associated with Ro examines the patient’s details and may request a lab test if additional information is necessary, as stated on the company’s website.

Ro spokesperson Nicholas Samonas noted that patients can arrange coaching sessions with a nurse or reach out to their provider or pharmacist if they have any inquiries or need assistance.

Health marketplace Sesame, among the newest companies to provide compounded semaglutides, mandates an in-person consultation with a provider and offers their product in prefilled, single-use syringes to minimize overdosing risks.

“This essentially eliminates the responsibility of dosing from the patient,” Michael Botta, co-founder and president of Sesame, told YSL News.

“For the first time, we are confident in offering compounded semaglutide to patients and clinicians via Sesame, and we are moving forward with this initiative.”

What is the future of compounded semaglutides?

The availability of compounded semaglutide is closely tied to the shortage of the brand-name versions, creating a sense of urgency. In January, Novo Nordisk pledged to double the supply of lower-dose Wegovy in the U.S. and plans to gradually boost availability throughout the year.

This has sparked concerns for patients like Lange. With the current high costs of Wegovy, she fears she may have to stop her weight loss medications abruptly if the shortage resolves and compounded alternatives are no longer in stock.

Research indicates that many individuals may regain some or all of the weight they lost after discontinuing GLP-1 medications.

Lange is eager to maintain her weight loss with her year-long supply of GLP-1 drugs but expresses concern about their potential discontinuation and the return of cravings that lead her to eat under stress.

“Everyone is anxious that the problem might resurface. That’s a big worry for me because it has been so effective,” she stated.