Understanding Patient Safety Concerns Surrounding Compounded Tirzepatide

6 hours ago
4 min read

By Monica P. Mallampalli, PhD

Tirzepatide has gained attention as a promising treatment for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. However, the rise of compounded tirzepatide products has raised serious concerns for patient safety. Patients and healthcare providers must understand the risks involved with compounded versions of this medication to avoid potential harm to patients.

What Is Tirzepatide and Why Is It Important?

Tirzepatide is a prescription medication first developed to help manage blood sugar levels in adults with type 2 diabetes. It is a combination drug composed of a long-acting glucose-dependent insulinotropic polypeptide (GIP) analog and a GLP-1 receptor agonist which then selectively bind to and activate the GIP and GLP-1 receptors. Tirzepatide works by activating receptors that regulate insulin and appetite, helping patients control glucose and reduce weight. Approved by the FDA, tirzepatide is manufactured under strict quality controls to ensure safety and effectiveness.

FDA has only approved two tirzepatide products so far: Mounjaro^® and Zepbound^®. Mounjaro^® received FDA approval in May 2022 for the treatment of type 2 diabetes, while Zepbound^® was approved by the FDA in November 2023 for long-term weight loss in adults with obesity and have either diabetes or an elevated risk of cardiovascular conditions. In December 2024, Zepbound^® received an added indication for OSA in adults with obesity, making it the first pharmaceutical treatment for OSA.

What is a Drug Shortage and How it Relates to Compounding?

Tirzepatide's success led to increased demand exceeding its supply in the United States, leading FDA to place this medication on drug shortage list on December 15, 2022. Once placed on the FDA's drug shortage list, compounding pharmacies are allowed to create medications under Section 503A of the Food, Drug, and Cosmetic (FD&C) Act. However, Section 503A also explicitly states that neither licensed pharmacists nor physicians can make copies when the medications become commercially available.

Only sterile pre-filled injectables of tirzepatide were placed on the FDA shortage list, not single-dose vial products. However, online and compounding pharmacies have been marketing and selling “copycat” versions of the injectables, vials, and, in some instances, tablet versions of tirzepatide. It is important to note that oral forms and nasal forms of tirzepatide are counterfeit medications and have never been studied for safety and efficacy by their manufacturers, nor have they been approved by the FDA.

Why Compounded Tirzepatide Is Risky

Compounded medications can work for patients, but safety and efficacy problems can arise since these medications are altered to be copycats. They may contain contaminants or impurities, inconsistent amounts of active ingredients, incorrect dosages, and even incorrect ingredients, leaving patients vulnerable to a variety of adverse effects.

FDA removed tirzepatide from its shortage list by October 2, 2024, which meant that online and retail pharmacies could no longer sell compounded tirzepatide, leaving patients only the commercially available, FDA-approved tirzepatide. By November 2024, the FDA had received more than 215 reports of adverse events related to compounded tirzepatide.

Regulatory Actions and Industry Response

The FDA is clear that approved medications should be used when available; however, some compounding and retail pharmacies ignored this warning and continued to market their medications despite their potential safety risks.

On February 6, 2026, the FDA announced that it intends to take action against companies mass selling compounded GLP-1 drugs to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.

FDA has taken steps to combat misleading direct-to-consumer advertising and marketing by companies that:

Claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA
State compounded drugs use the same active ingredient as the FDA-approved drugs
Advertise that compounded drugs are clinically proven to produce results for the patient

What Does the FDA's decision Mean for Patients?

Patients should be vigilant when obtaining tirzepatide. Commercially available tirzepatide is accessible for patients seeking treatment for obesity along with diabetes or increased cardiovascular risk. Zepbound^® for the treatment of obesity and OSA is available to Medicare Part D recipients. But patients seeking this medication from private insurers should speak to their sleep physicians on accessing this treatment. Often, private insurance companies require prior authorization and physicians can help their patients by submitting appeals to insurance companies, citing information on the FDA approval and CMS decision regarding tirzepatide.

Here are practical tips to ensure you receive a safe, FDA-approved product:

Ask Your Healthcare Provider
Confirm that the tirzepatide prescribed is FDA-approved and sourced from a reputable manufacturer.
Check the Source
LillyDirect is an online pharmacy service offered by the manufacturer of Zepbound^®and provides easy access to this medication. Ensure that retail and other online pharmacies are reputable and are appropriately licensed to fill your prescription. Avoid offers from online, TV, or unverified sources that claim to sell tirzepatide and its many forms at unusually low prices.
Look for Proper Packaging
FDA-approved tirzepatide comes in sealed, labeled packaging with clear instructions and expiration dates.
Be Wary of Compounded Claims
If a pharmacy offers to compound tirzepatide, ask why and be wary. Be an informed patient.

What Patients Should Do If They Have Used Compounded Tirzepatide

If you have used compounded tirzepatide, consider the following actions:

Monitor Your Health
Watch for any unusual symptoms such as allergic reactions, infections, or worsening diabetes control.
Contact Your Healthcare Provider
Discuss any concerns or side effects immediately.
Report Issues
Inform the FDA or your local health department about any adverse effects.

Final Thoughts

Compounded tirzepatide can pose significant risks due to lack of regulation, quality control, and safety data. Patients and providers must prioritize use of FDA-approved tirzepatide to ensure effective and safe treatment. Always verify the source of your medication and stay informed about potential dangers. Protect your health by choosing approved therapies and consulting trusted healthcare professionals.