Tirzepatide, marketed as Mounjaro and Zepbound, has been a groundbreaking weight loss medication. By mimicking natural hormones that regulate appetite and insulin, tirzepatide not only promotes weight loss but also helps improve metabolic health.
However, because of the drug’s increased demand, the US Food and Drug Administration (FDA) added tirzepatide (Mounjaro/Zepbound) to its drugs shortage list on December 15, 2022.
The shortage was announced less than a year after the drug was first approved to treat type 2 diabetes as Mounjaro in May 2022. Tirzepatide was later approved for treating obesity under the brand name Zepbound in November 2023.
On October 2, 2024, the FDA announced that tirzepatide is no longer in shortage. But what is the FDA’s stance on compounding tirzepatide?
Tirzepatide Removal from FDA’s Shortage List
On October 2, the FDA’s Drug Shortage Database indicated that the tirzepatide shortage has been “resolved.” In a statement directed at compounders, the agency stated that Lilly can supply the “present and projected national demand” and that compounders are not allowed to make the drugs.
However, the FDA stated in the release that “patients and prescribers may still experience irregular, localized supply disruptions as the medicines pass through the supply chain from the manufacturer and distributors to local pharmacies.”
Organizations like the Outsourcing Facilities Association and FarmaKeio Custom Compounding have filed a complaint arguing that the FDA’s move is based solely on the manufacturer’s production capacity, raising concerns about potential favoritism toward special interests while neglecting patients’ needs.
Critics contend that the FDA’s decision, made without prior notice or public consultation, may deprive patients of necessary care and could lead to increased drug prices. This complaint highlights the importance of drug compounding, which legally allows for tailored treatments when medications are in shortage or when a patient is allergic to a certain ingredient and needs the medication without it.
At NP2GO, we recognize the complexity of this unprecedented situation and are committed to navigating its legal, medical, and ethical implications. Our primary focus remains on ensuring patient access to critical treatments at all times.
As we continue to monitor these developments, NP2GO prioritizes our patients’ needs, ensuring they have access to the best possible weight loss treatment options. We remain dedicated to providing reliable solutions, including tirzepatide, while advocating for patient rights and accessibility.
Tirzepatide Impact on Weight Loss
Tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for weight loss, has shown promising results in promoting weight loss in people with obesity or overweight. As a dual-action medication that targets both the GLP-1 (glucagon-like peptide) and GIP (glucose-dependent insulinotropic polypeptide) hormone receptors, tirzepatide effectively regulates appetite and enhances insulin sensitivity, leading to significant weight loss.
Clinical trials have shown that patients using tirzepatide experienced greater weight loss than those on placebo. In the first tirzepatide clinical trial, more than 2,500 participants who were classified as obese or overweight lost a considerable amount of weight. Over 72 weeks, or 16.5 months, those taking tirzepatide experienced an average weight loss of 15% to 20% of their starting body weight. As a result, the average weight loss was between 34 and 48 pounds. The average weight loss for those receiving the placebo was only 3%.
Furthermore, more than one-third of patients receiving the maximum dosage of tirzepatide (15 mg weekly) saw a loss of at least 25% of their initial body weight (more than 58 lbs).
Tirzepatide has also been associated with improved metabolic health markers, including reduced blood sugar levels and lipid profiles.
How NP2GO Can Help at this Time
At NP2GO, we are committed to remaining informed and responsive to any changes in the availability of tirzepatide. We understand how important this medication is for effective weight loss treatment, and we will keep you updated on developments that affect your care.
In addition to tirzepatide, we offer other effective weight-loss medications, including semaglutide, also known for its high impact on weight management. We are dedicated to finding the best treatment options tailored to your unique needs.
Take the next step in your weight loss journey by booking a consultation with our experienced team. Whether you are interested in tirzepatide*, or exploring other weight loss solutions we offer, we are here to provide the guidance and support you need.
*Only available by compound while on FDA shortage list.