Brittany Mahomes’ Instagram is the subject of a recent letter the FDA sent to Kaléo regarding a misleading direct-to-consumer ad for its epinephrine injection.
The FDA called the Instagram post and video misleading because they presented efficacy claims for Auvi-Q but failed to communicate any risk information other than a statement that said: “For Important Safety Information, visit@auviq_ISI.” Both have been deleted.
The untitled letter, dated July 17, notes that the statement and link do not make up for the missing risk information. The agency said the self-injector comes with warnings and precautions related to serious infections and allergic reactions, as well as other potential side effects like dizziness, nausea and vomiting, headache, and respiratory difficulties.
Kaléo has two weeks to respond to the FDA.
“Kaléo is in receipt of the untitled letter and take such matters very seriously,” a spokesperson said via email. “We will respond to the FDA accordingly.”
Kaléo and Mahomes, co-owner of the Kansas City women’s pro soccer team and wife of Kansas City Chiefs quarterback Patrick Mahomes, have worked together since at least January.
This is just the second untitled letter sent by the FDA’s Office of Prescription Drug Promotion so far this year. OPDP has consistently reduced the number of letters it sends each year to pharma companies, issuing seven letters in 2019 and a total of seven letters in 2022 and 2023.
This also isn’t the first time that the FDA has gone after a celebrity’s paid Instagram post. In 2015, the agency warned specialty pharma company Duchesnay that Kim Kardashian’s sponsored post on its morning sickness drug Diclegis omitted risk information. The post had more than 450,000 likes.