The FDA recently in October 2024 that the Tirzepatide shortage is over, after nearly 2 years on the list, and compounders have about 60 days to cease mass production. Within days, a trade group representing the largest compounding pharmacies – the Outsourcing Facilities Association – sued the FDA. Compounding pharmacies will be allowed to continue for now, but it is worth considering the long-term consequences and how it may impact your weight loss.
Tirzepatide is an important drug used in the treatment of type 2 diabetes and increasingly, of late, for weight loss. The ending shortage had raised concerns among patients and healthcare providers about the ability for patients to continuation of their care.
What is an FDA Drug Shortage?
An FDA drug shortage occurs when the supply of a drug is not sufficient to meet demand. This can happen for several reasons:
- Manufacturing issues
- Supply chain disruptions
- Increased demand for a particular medication
When a shortage is declared, the FDA may take steps to help mitigate the issue, like working with manufacturers to speed up production or allowing for temporary alternatives like compounded medications to produce a similar medication. Compounded medications do not have the same history of clinical trials, and they often include small adjustments or customizations that could work better for you.
Why Was Tirzepatide on the FDA Drug Shortage List?
Tirzepatide is the active ingredient in the drug Mounjaro. Mounjaro gained international attention for its success in treating type 2 diabetes, and the inability to ramp up production quickly enough created a concern among patients who relied on it.
The surge in demand was largely driven upon its promising results for weight management similar to those using Ozempic for weight loss. Many people who struggle with traditional diet and exercise alone have turned to medications like tirzepatide to help achieve their goals by complementing their efforts with appetite suppression.
Manufacturing constraints further compounded the problem. As a result, in 2022, the FDA placed tirzepatide on its shortage list, allowing for compounded tirzepatide to be made temporarily available. There is no available data, but Novo Nordisk has estimated that up to 20% or 2 million patients are using compounded drugs.
What Drugs Contain Tirzepatide?
Currently, the most well-known drug containing tirzepatide is Mounjaro, which is manufactured by Eli Lilly. This drug is primarily used to manage type 2 diabetes by regulating blood sugar levels. However, it has gained increasing attention for its secondary benefit – weight loss.
Zepbound, a newer product containing tirzepatide, was also recently approved for weight loss. Both it and Mounjaro work by mimicking natural hormones that regulate blood sugar and appetite, making them effective for diabetes management and weight reduction.
What Happens When a Drug Shortage is Resolved?
When a drug is no longer considered in shortage, certain temporary measures are lifted. In the case of tirzepatide, once the FDA declared the shortage resolved, pharmacies that had been producing compounded tirzepatide were told they had to scale back production.
This transition back to only FDA-approved versions of the drug is a challenging process. A patients’ body might not react exactly the same to the branded versions due to some minor differences, disrupting a patients’ care. Additionally, compounded tirzepatide is often significantly cheaper. With insurance often not paying for weight loss, patients may struggle to afford medical weight loss. Doctors will have a matter of weeks to transition their patients to a the branded medication or a similar compound for patients to continue their treatment.
Alternative Options for Patients During the Tirzepatide Shortage
During the shortage, many patients turned to alternatives, including compounded tirzepatide. While these versions filled the gap, there are some risks associated with compounded drugs:
- Lack of FDA approval
- Potential variations in dosage or purity
Patients should consult their healthcare provider before switching to compounded medications after considering the options available. In some cases, other medications, such as semaglutide (the active ingredient in Wegovy and Ozempic), may be suitable alternatives.
Semaglutide currently faces shortages, and it remains a viable option for some patients. It works similarly to tirzepatide by helping regulate blood sugar levels and suppressing appetite.
Future Outlook for Tirzepatide Availability
Eli Lilly, the manufacturer of Mounjaro, has been increasing production to meet the high demand for its medication. Fluctuations in supply may still persist in some areas so patients should continue to work closely with their healthcare providers.
Continued expansion of manufacturing capabilities and the introduction of new suppliers will help ensure that patients have reliable access to this important medication.
FAQs
Why was tirzepatide in shortage?
A combination of high demand, especially for its use in weight loss, and manufacturing delays caused the shortage.
Is tirzepatide still in shortage?
As of October 2024, the FDA has indicated that tirzepatide is no longer in shortage, but availability may still be limited in certain areas.
Can I still get compounded tirzepatide?
No, once the FDA declared the shortage resolved, pharmacies were no longer allowed to provide compounded tirzepatide.
What are the alternatives to tirzepatide?
Alternatives like semaglutide (found in Ozempic and Wegovy) may be suitable, especially for those using it for weight loss.
