As obesity providers at New You, our mission is dedicated to helping people living with obesity gain back their life and health, and we strive to be mindful and dedicated advocates for the issues and concerns of the community of people we serve. People with obesity have been burdened not only with impaired quality of life and health but also by generations of social stigma, blame from medical providers, and overall judgment from the general public. However, advancements from the medical and scientific community have furthered our understanding of obesity as a chronic medical condition rather than a lifestyle choice or an aesthetic concern. As a result of lots of research and testing, several highly effective treatments have become available to treat obesity.
Some anti-obesity medications (AOMs) like Wegovy (semaglutide) and Zepbound (tirzepitide) have demonstrated exceptional results that have garnered a huge amount of exposure through social media and news sources. Due to the overwhelming popularity of these FDA-approved medications, worldwide shortages have impacted millions. After all, the current adult obesity rate among the American population is over 40%. Because of the growing problem of obesity and the associated stigma, people with obesity are vulnerable to misinformation they find online or by word-of-mouth as they desperately seek ANY solution for reducing their weight. We want to take this opportunity to clarify for people living with obesity. We take our patients’ life and health very seriously, and for this reason, we discourage our patients from purchasing compounded AOMs.
Lack of Safety:
The Food and Drug Administration (FDA) oversees the regulation of prescription medications approved in this country. This important function provides a necessary safety net for patients who put the medications in their bodies and the providers who write the prescriptions. The FDA is not meant to protect the drug manufacturers; it’s meant to protect the patient, so the importance of its role cannot be over-emphasized.
Shortages of FDA-approved medications must be reported to the public via the FDA’s website. This has provided a regulatory loophole in patent and trademark laws that has allowed a widespread surge in compounded “copies” of the commercially available versions of the approved medications. There is no FDA oversight whatsoever of these substances. Regardless of how desperately you want to lose weight, we strongly advise that this is not safe.
False Claims:
Many patients believe that compounded medications which purportedly contain the “same active ingredient” as semaglutide or tirzepitide are going to provide the same results. This is just simply not true, and it cannot be proven. The FDA approval not only includes approval of the “active ingredient,” but it also includes all the elements that make that ingredient “active” – the manufacturing processes and facilities, the pens, vials and needles of the delivery device, the shipping and storage temperature controls, and even the product’s expiration date. Even if you could be ASSURED that a compounded drug contains the same active ingredient as the brand-name product, all the other elements that contribute to the mechanism of action, consistency, stability and safety of the drug have not and cannot be duplicated without violating the federal patents owned by the manufacturers of these medications. Compounding medications has been a long-accepted practice for a variety of conditions like cancer and chronic pain. However, buyer beware of someone trying to convince you that they can make weight loss easy and quick, because they are very likely trying to sell you something rather than help you treat your disease.
Buyers of these compounded medications are also often falsely assured that the compounding facilities are regulated, but this in absolutely NO WAY matches the FDA standards in place to protect the public. Just because a substance is clean and sterile doesn’t make it safe to put in your body.
Lack of Effectiveness:
In addition to safety concerns, we also believe that the practice of compounding weight loss medications has become predatory against people living with obesity who are desperate for a solution and willing to try almost anything at any cost. Treatments that are unsustainable, unaffordable, and unproven are not appropriate for treating a serious, chronic disease with multiple health risk factors. We feel our patients deserve treatment with outcomes that can be proven.
Because there are no regulations in place for compounded AOMs, there is no consistency with regards to dosage, so each dose might contain nothing at all, or it might contain too much. Taking an unknown substance in a questionable dose will not help with weight in any predictable way, and it’s taking financial resources away from other proven treatments. We have heard from so many patients who have spent hundreds and thousands of dollars and did not experience any weight loss at all. This is an expensive lesson that we try to help our patients avoid.
Lack of Support:
ALL of the medications prescribed for weight loss are intended to be prescribed along with lifestyle modifications and are NOT meant to replace those efforts. There are important side effects that must be monitored, contraindications that must be assessed, and dietary recommendations associated with taking AOMs. Before you take any prescription medication, you must be appropriately assessed and examined. If you are getting your weight loss treatment from someone without obesity medicine experience at a med spa or a chiropractor, you are cheating yourself and taking risks with your health.
We strongly encourage patients to consider their path to weight loss carefully. You should consider your health, your finances, your safety and your life more important than taking a blind risk on a dose of something that may harm you. Please talk with the experienced, knowledgeable New You providers about any questions or concerns regarding AOMs before trying anything new.