From the FDA Drug Label
MOUNJARO is contraindicated in patients with: A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)]. Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO.
The contraindications for Mounjaro are:
- Personal or family history of medullary thyroid carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO 1, 1, 1
From the Research
Mounjaro (tirzepatide) is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This recommendation is based on the potential risk of thyroid cancer associated with the use of GLP-1 and GIP receptor agonists, as suggested by studies such as 2, which discusses the molecular basis of MEN2A, MEN2B, and FMTC. However, a more recent study 3 found that tirzepatide did not increase the overall or specific cancer risk, including thyroid cancer, in patients with and without diabetes.
Despite this, the contraindication in patients with a history of MTC or MEN 2 remains due to the potential risk, although the evidence from 3 may suggest a reevaluation of this contraindication in the future.
- Mounjaro should not be used in patients with a history of serious hypersensitivity reactions to tirzepatide or any of the product components.
- Mounjaro is also contraindicated during pregnancy as weight loss offers no benefit to pregnant women and may cause fetal harm.
- Patients with severe gastrointestinal disease, including severe gastroparesis, should avoid Mounjaro due to its effects on gastric emptying.
- Caution is advised in patients with diabetic retinopathy, pancreatitis, or severe renal impairment, though these are not absolute contraindications.
- The medication should be used carefully in patients taking other medications that lower blood glucose, as it may increase the risk of hypoglycemia. These contraindications and precautions exist because tirzepatide, as a GLP-1 and GIP receptor agonist, affects multiple body systems, including pancreatic function, gastric emptying, and potentially thyroid tissue, making careful patient selection essential for safe use, as supported by the findings of 3.