Compounded Semaglutide and Tirzepatide: Are They Safe to Use?

Second-generation weight loss medications have started to generate a lot of buzz.  Well-known icons such as the Kardashians and Elon Musk have talked about their effectiveness for weight loss. And it is true that Semaglutide (Ozempic and Wegovy) and Tirzepatide (Mounjaro and Zepbound) can deliver better and more sustained weight loss than previous medications.

These drugs work by slowing down gastric emptying so that in many cases patients feel increased satiety.  They can also help to sensitize patients to their own insulin, which can help to overcome insulin resistance. Studies indicate that Semaglutide can yield between 12% and 15% weight loss depending on the dose, and Tirzepatide may yield up to 20% weight loss. In addition, these medications seem to continue to be effective for most people as long as they continue to take them.

However, as many patients have recently discovered, the cost of these medications can be prohibitive. Semaglutide and Tirzepatide each cost between $1,100 and $1,300 per month. In fact the cost is so high that most insurance plans are now refusing to pay for these medications and have removed them from their formulary. Insurers are happy for you to take them as long as you are willing to pay for them out of your own pocket. If you are like many people, this is cost prohibitive; the cost of these medications is generally >$14,000 per year.

This has given rise to a gray market of sorts for these medications. National compounding pharmacies have decided to attempt to work around patents held by Novo Nordisk and Eli Lilly to produce these compounds themselves and then retail them at a fraction of the cost. This has lowered the cost; in many cases patients can obtain a version of these medications for closer to $500 to $700 per month rather than $1,300 per month. But it raises important questions about the legality, safety, and efficacy of these medications.

Is This Legal?

Compounding pharmacies are attempting to get around the legally enforceable patent in two ways. First, they’re claiming that these medications are in short supply. Second, they’re adding additional peptides into a mixture that they claim is different than the original drug. This means that they have in effect produced their own unpatented Semaglutide or Tirzepatide and then mixed these with other peptides to try to call the final compounded result a new drug. We are still waiting to see how the legality of all this shakes out, but there are reports of at least one possible pending lawsuit.

Are There Long-Term Risks Associated With Compounded Semaglutide and Tirzepatide?

 This question has not yet been answered. The reconstituted mix of novel peptides has not been tested in any study by any compounding pharmacy. Additionally, the safety of these compounded versions is not endorsed or monitored by the FDA. When it comes to compounded Semaglutide safety (as well as compounded Tirzepatide safety), we are very much in the territory of “buyer beware.”

Additionally, there are even baseline concerns about potentially serious gastro-intestinal complications of the legal non-compounded medications. These include gastroparesis (paralysis of the stomach), pancreatitis (autodigestion of the pancreas, which can be very serious), and bowel obstruction. The rate of Tirzepatide or Semaglutide side effects in clinical studies can range from 20% to over 40%. There are also concerns about a higher incidence of Endocrine tumors (pancreatic and pituitary). On top of these concerns, the novel compounded versions of these medications have not been studied to determine if there are additional Tirzepatide or Semaglutide safety concerns.

Are Compounded Semaglutide or Tirzepatide As Effective As Non-Compounded Versions?

Again, to date there are no studies confirming the effectiveness of compounded drugs either in the short- or long-term. Additionally, the efficacy of these compounded versions is not endorsed or monitored by the FDA. And in many cases, compounded pharmacies do not share details confirming the source, certification, or dosing of these medications.

In short, these novel compounded combinations have not been studied to verify their safety or efficacy. The question of compounded Semaglutide safety is therefore still up in the air.

At present these pharmacies are attempting to exploit a loophole to not only circumvent the legal patents but also to avoid medical regulation, leading to very serious concerns about compounded Semaglutide safety as well as the safety of compounded Tirzepatide.

Bariatric Surgery: A Better Alternative

Even if national study results are achieved, we must ask if these results are worth it when compared to other weight loss mechanisms such as bariatric surgery. These medications on average yield up to 20% total weight loss. For people struggling to lose weight, that may sound like a lot, but bariatric surgery can help patients lose 90% or more of their unhealthy body weight. Imagine how that would feel.

Even if you elect to pay for your bariatric surgery out of pocket, our all-in-one pricing model starts at around $12,000. That’s less than 1 year of non-compounded Semaglutide or Tirzepatide and is about equal in cost to 2 years of compounded Semaglutide or Tirzepatide. Remember that these compounds only continue to deliver weight loss while they are being taken. That means that a 1-2 year investment in medication only translates to 1-2 years at a lower weight. By contrast, a one-time investment in bariatric surgery, when paired with diet and exercise changes, can yield potential lifelong weight loss.

Additionally, most insurances will cover a portion or all of your bariatric surgical costs, which optimizes your value even more. At our center the complication rate is exceedingly low. When it comes to safety, bariatric surgery is on the same or lower level as these medications.

If you are looking for your best weight loss value and a pathway to significant and long-standing weight loss, it is very important to consider all aspects of the value equation. We hope that this has given you good solid information to consider when making your decision about your weight loss future. While Semaglutide and Tirzepatide may be the right choice for some people, everyone should use significant caution when considering compounding pharmacy sources. For many patients who are seeking more significant weight loss and a permanent tool that will not continue to cost them over time, bariatric surgery is still the most affordable, most effective, safest, and highest-value option available for long-term weight loss and metabolic health.

Most of our patients say that bariatric surgery was the best decision they ever made.

“I can only thank Dr. Long and his staff for giving me my life back. I have set some new goals for myself and look forward to walking a 5k and participating in a triathlon.”—Johnetta Hebrlee, duodenal switch patient.

If you’re suffering, don’t wait. Contact our Denver office today.