Do compounded weight loss medications work, and are they safe?

We are in an exciting era of new and emerging weight management medications that can facilitate impressive amounts of weight loss for many people. With news about these treatments exploding on social media around the world, demand has been so high that these medications are now on shortage in some places, and have not even made it to market in many countries (despite being approved for use), as supply cannot keep up with this incredible demand. In addition, these medications are expensive, and many people are not able to afford the hefty price tag. Due to these shortages and high costs, some people are turning in desperation to compounded preparations of these medications.

The two medications we are talking about here are:

Semaglutide: approved for the treatment of type 2 diabetes as subcutaneous (under the skin) injectable doses of 0.5mg, 1mg, or 2mg weekly (called Ozempic), and for weight management at a dose of 2.4mg injectable weekly (called Wegovy). Semaglutide is also available in a pill form called Rybelsus, for treatment of type 2 diabetes (7mg or 14mg daily).

Tirzepatide: approved for the treatment of type 2 diabetes at subcutaneous injectable doses of 5mg, 10mg, and 15mg weekly (trade name Mounjaro). It has been studied extensively as a weight management medication, but awaits publication of all key clinical trials and regulatory review before it (likely) becomes approved as an obesity treatment.

What are compounded semaglutide and compounded tirzepatide?

In general, compounding involves combining, mixing, or altering pharmaceutical ingredients. This can involve adjusting the dosage strength, removing or adding ingredients. What is being added to semaglutide or tirzepatide at compounding pharmacies is not always clear. I have seen some advertisements where vitamin B6 (aka pyridoxine, purported to help manage nausea) or vitamin B12 (‘for energy’) are added. There are no clinical trials of these additives with these medications to see if there is actually any benefit.

Are compounded semaglutide or tirzepatide effective for weight loss, and are they safe to use?

We don’t know. First of all, there are a lot of questions about the contents of these compounded products. How compounding pharmacies would get semaglutide or tirzepatide in the first place to compound is unknown, as both medications are under patent by the pharmaceutical companies that make them, and thus not produced or distributed for compounding purposes. The American FDA has received reports that compounders may be using salt forms of semaglutide, noting that there is no known basis for using salt forms that meets the requirements for types of active ingredients that can be compounded. Also, compounded preparations have not been studied in clinical trials, and regulatory agencies (like the FDA or Health Canada) do not verify safety nor efficacy of compounded drugs.

I have also seen ads for semaglutide as rapid dissolve tablets (intended to be absorbed into the body directly from the mouth) made by compounding pharmacies, which makes no sense from a scientific perspective. The prescription semaglutide pill (Rybelsus) has to be swallowed, as it is absorbed by the stomach lining using a special technology that protects the peptide (hormonally-based protein) from stomach acid. There is no data to support how much (if any) semaglutide would be absorbed by the lining of the mouth with a rapid dissolve tablet. The semaglutide dosing I have seen for this rapid dissolve tablet are similar doses as injectable Ozempic, yet (as above) Rybelsus dosing is quite different.

The price tags on these compounded medications is cheaper than prescription semaglutide or tirzepatide, but I’m disheartened to know that people paying for these compounded medications may be wasting money on something that doesn’t actually work, and for which we do not have safety data.

The Obesity Medicine Association (USA) and FDA have both issued statements regarding the lack of data on safety and efficacy, questions about what is in these preparations, and potential dangers of these compounded formulations.

BOTTOM LINE: Access to effective weight management medication is limited by demand and by cost. We need to continue to advocate for access to treatment for all people who need it, not just those who live in affluent nations and/or can afford to pay. Turning to compounded preparations is not the answer. We do not have data on safety nor efficacy of compounded semaglutide nor tirzepatide, and their use is therefore not recommended.

Disclaimer: I am an investigator in clinical trials of semaglutide and tirzepatide. I receive honoraria as a continuing medical education speaker and consultant from the makers of semaglutide (Novo Nordisk) and tirzepatide (Eli Lilly).

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