The Allure (and Risk) of Compounded Semaglutide and Tirzepatide: What You Need to Know

Expert Insights From Dr. Pope

Have you seen the social media ads or internet banners promoting compounded semaglutide and tirzepatide for weight loss or diabetes management? They often promise significant savings compared to the brand-name versions, Ozempic and Wegovy (semaglutide) and Mounjaro (tirzepatide). These sky-high costs and frequent shortages of the brand-name drugs can be incredibly frustrating, making these alternative offers seem tempting. But before you jump on the bandwagon, it’s crucial to understand the key differences and potential risks involved.

Why are Brand-Name Semaglutide and Tirzepatide So Expensive?

Semaglutide and tirzepatide are injectable medications belonging to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. They work by mimicking a natural hormone that helps regulate blood sugar and appetite. These medications have been highly effective in treating type 2 diabetes and promoting weight loss, leading to a surge in demand. However, this popularity has been met with supply chain issues, resulting in frequent shortages of the brand-name versions. Additionally, these medications are relatively new, and pharmaceutical companies can set high prices during their patent exclusivity period to recoup development costs. These factors combine to make the brand-name drugs very expensive, often exceeding $1,000 per month out-of-pocket, even with insurance coverage.

Enter Compounding Pharmacies: A Legal Loophole?

So, how can compounding pharmacies offer significantly lower prices for semaglutide and tirzepatide? The answer lies in the concept of drug shortages. The FDA maintains a list of drugs experiencing shortages, and semaglutide and tirzepatide are currently on that list (as of March 2024). This designation allows licensed compounding pharmacies to prepare compounded versions of these medications under certain circumstances.

What are Compounded Medications?

Compounding pharmacies are a legitimate part of the healthcare system and play a valuable role in creating customized medications for patients with specific needs. For example, they might combine medications into a single dosage form for a patient who has difficulty swallowing multiple pills. However, it’s important to understand that compounded medications are not the same as FDA-approved drugs.

The Risks of Compounded Semaglutide and Tirzepatide

Here’s where things get complicated:

  • Unapproved by the FDA: The compounded versions of semaglutide and tirzepatide have not been reviewed and approved by the FDA for safety and efficacy. This means there’s no guarantee they work the same way or carry the same side effects as the brand-name drugs. Although, this holds true of any medication received by a compounding pharmacy, and yet compounded medications are dispensed everyday in every state across the USA.
  • Variability in Quality: Compounding pharmacies have more flexibility in sourcing ingredients and formulating medications. This can lead to inconsistencies in the final product, potentially affecting its dosage, effectiveness, and safety. Obviously, the compounding pharmacies have to offer similar quality and efficacy else they would be continue as a pharmacy for long, so the quality issues, while a valid concern, are usually negligible.
  • Limited Oversight: While compounding pharmacies are licensed and regulated by state boards of pharmacy, the oversight process may not be as rigorous as the FDA’s approval process for new drugs.
  • Unknown Long-Term Effects: Since these compounded versions are new, there’s no data on their long-term safety or effectiveness. Although, the active ingredient should be the same as in the brand name medication, which does have years of data to back it up.

Beyond Cost: Considering the Bigger Picture

The allure of compounded semaglutide and tirzepatide is understandable, especially with the high cost and frequent shortages of the brand-name drugs. However, there are potential risks associated with compounded versions, as there can be varying quality among the different pharmacies. In general, it should not be an issue if purchasing from a well known and long established compounding pharmacy.

At the end of the day, these medications are quite possibly once in a generation medications that have the potential to change the lives of many diabetic and overweight patients. The high cost and limited access have led to a burgeoning market of compounded versions of these medications. Many patients have had significant success using these options, but just remember, the affordability comes at the risk of varying quality and if the medications are no longer deemed as being under an FDA shortage, then supply could literally stop overnight.

Patients need to work with their physician to determine the right path for them on their weight loss journey. As always, exercise/diet/lifestyle change is an essential part in any lasting change. Tirzepatide and Semaglutide are just one ingredient in that journey, although it appears that they are one of the most potent ingredients to date.