FDA adds hair loss to Mounjaro label and removes two limitations of use
The FDA added hair loss to Mounjaro's prescribing information and deleted two limitations of use, a labeling change the agency said aligns with other GLP-1 receptor agonist products.
The FDA approved a label change for Mounjaro (tirzepatide) on May 28, 2025, adding alopecia — the medical term for hair loss — to the drug's prescribing information and removing two limitations of use [1]. The approval, effective the date of the letter, covers supplement NDA 215866/S-031, which Eli Lilly and Company submitted on February 28, 2025 [1].
The agency had asked for the hair loss term in a February 3, 2025, Supplement Request letter, and the company's supplement, as the FDA describes it, "provides for revision to Subsection 6.2 Postmarketing Experience of the Prescribing Information (PI) to include the term 'alopecia'" [1]. The approval letter does not say how many cases of hair loss were reported, how severe they were, or whether the FDA concluded that tirzepatide caused them. Those details have not been disclosed [1].
In Section 1, Indications and Usage, the FDA removed two Limitations of Use: "Is not indicated for use in patients with type 1 diabetes mellitus" and "Has not been studied in patients with a history of pancreatitis" [1]. The letter says these and other revisions were made "to align with recently approved changes in other products in the glucagon-like peptide-1 receptor agonist class" [1].
The approval letter does not state that Mounjaro is now indicated for people with type 1 diabetes, and it does not describe new studies of the drug in people with a history of pancreatitis [1]. It also does not describe any change to the approved indication itself, only the removal of the two limitations [1].
The FDA said additional edits were made throughout the prescribing information and Medication Guide "to modernize with current labeling guidances, clarify language, and improve readability and organization of information" [1]. The approved labeling enclosed with the letter includes the Prescribing Information, Medication Guide, instructions for use for the vial and the single-dose pen, and a quick reference guide [1]. The letter is signed by Monika Houstoun, Pharm.D., M.P.H., deputy director for safety in the FDA's Division of Diabetes, Lipid Disorders, and Obesity [1].
Why it matters for patients
People who take Mounjaro will now see hair loss named in the drug's prescribing information [1]. The term was added to the section of the label titled Postmarketing Experience [1]. The letter does not describe how often hair loss was reported relative to the number of people who have used the drug, so it is not yet known from this document how common the reports were [1].
A person with type 1 diabetes, or with a history of pancreatitis, who reads the Mounjaro label will no longer see those two limiting statements [1]. The removal does not by itself show that the drug has been tested in those groups; the letter does not explain what evidence supported the change beyond aligning with other drugs in the class [1].
The changes apply to the Mounjaro labeling covered by this supplement. The letter does not address any other tirzepatide product [1].
What happens next
Under the terms of the letter, the company must submit the updated labeling in structured product labeling format within 14 days of the May 28, 2025, letter, a deadline that falls around June 11, 2025 [1]. Promotional materials that mention the drug must be revised to match the new labeling, and the company must send a statement of intent to comply within seven days of receiving the letter, or about June 4, 2025 [1]. The letter also notes patent listing requirements: certain changes require patent information to be filed on Form FDA 3542 within 30 days of approval, or by about June 27, 2025 [1].
Sources
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