Written by Dr. Tejaswi Kompala, Head of Cardiometabolic Clinical Strategy, Teladoc Health
Patients who would benefit from a GLP-1 face significant challenges when it comes to access. Shortages have made it difficult to get a prescription. And even when available, the cost can be prohibitive. It leaves patients looking for answers.
When companies promote that they can deliver weight loss drugs to your door in a matter of days at a fraction of the cost, it’s easy to see the appeal. Compounded drugs make this possible. But is this a safe option for patients?
Drug compounding is the process of combining, mixing or changing ingredients to create a customized medication. It’s nothing new, but it’s typically done based on an individual patient’s needs. For example, drug compounding can create a drug in liquid form for a patient unable to swallow a pill or capsule.
Beyond serving an individual patient’s needs, drugs may be compounded when the approved drug is on the FDA’s drug shortages list. And it’s because of this situation with GLP-1s that has created a perfect storm for compounded GLP-1s to take off.
When GLP-1s are on the shortages list, compounders hurry to meet a market opportunity driven by high demand, prioritizing near-term gains over long-term safety and outcomes.
While there are some guardrails for manufacturing compounded drugs, they’re not FDA approved. Simply, this means the FDA does not verify their safety, effectiveness or quality. This is something patients and providers rely on for the informed use of a medication.
Good compounders—manufacturers that are following the appropriate rules and regulations—do exist. However, the scale at which GLP-1 compounding occurs makes it impossible to fully trust that these compounded medications are reliably equivalent to the FDA-approved versions.
Because many patients pay cash for compounded drugs, it’s difficult to identify unsafe sources. Despite these tracking challenges, the FDA has already documented multiple concerns on compounded GLP-1s, including compounders using semaglutide “salts,” which are not the same as the active pharmaceutical ingredient; warnings about adverse events from overdoses;and the rise of counterfeit semaglutide.
Then, there is the question about the long-term availability of compounded GLP-1s. As of early October 2024, semaglutide (Ozempic and Wegovy) remained on the FDA’s shortage list, while tirzepatide (Mounjaro and Zepbound) was officially removed (though the later is being reconsidered by the FDA). When patent exceptions no longer allow for compounded drugs to be manufactured, how will patients taking compounded drugs be affected? When supply is not an issue, the FDA is reminding compounders of restrictions “on making copies of FDA-approved drugs.”
At Teladoc Health, patient safety is a cornerstone of our approach. Patients in our care will only be prescribed branded, FDA-approved versions of obesity medications. We stand by this, knowing that their manufacturing process and facilities are FDA-inspected and that they follow the recommendations of leading organizations, like The Obesity Society, Obesity Action Coalition and Obesity Medicine Association.
Still, we acknowledge that barriers to GLP-1s for obesity are too common. Our providers are dedicated to empathetically caring for patients in potentially frustrating situations.
Our providers work with members to educate them on safe approaches to weight loss and the potential risks of compounded GLP-1s. Because our providers aren’t tied to one specific therapy, they take a personalized approach to working with members to understand their motivation. When patients need a safe approach as a temporary bridge because of supply chain issues, our providers look for alternative, safe anti-obesity medications.
A recent STAT article found that some virtual obesity care companies rely on “white label” medical networks. These networks frequently focus on prescribing only GLP-1s (including compounded versions) and not a broader set of cardiometabolic or anti-obesity medications. They may not have rigorous protocols for the diagnosis, evaluation, medication access and follow-up required for safely and effectively treating people on GLP-1s.
We prioritize the time and attention quality obesity care deserves. Our providers are part of the Teladoc Health Medical Group and are committed to clinical quality. Teladoc Health providers in our Weight Management program are focused on safe, compassionate, longitudinal care.
Patients deserve safe and effective obesity care programs, which should focus on supporting lifestyle change and the clinically appropriate prescribing of FDA-approved obesity medications. There are a lot of ways that compounded GLP-1s interfere with this approach. While they may seem like a viable fix given the circumstances, any benefits are fleeting. There’s no role for compounded GLP-1s in a safe, long-term weight and obesity care strategy.
