FDA Criticizes Brittany Mahomes’ Paid Instagram Post for Kaléo’s Auvi-Q

1. FDA Action: The FDA issued an untitled letter to Kaléo, criticizing a paid Instagram post by Brittany Mahomes for being "false or misleading" regarding the benefits of Auvi-Q, an epinephrine injection for food allergies in children.
2. Post Details: The post, which has since been taken down, highlighted Mahomes' concern for her children's safety and included a 30-second video promoting Auvi-Q without mentioning any warnings or risks associated with the drug.
3. Public Health Concerns: The FDA expressed concerns that the post created a misleading impression about the safety of Auvi-Q, which is used to treat life-threatening allergic reactions in infants and children.
4. Regulatory Context: This action is part of the FDA's broader efforts to address health misinformation on social media, particularly as influencers increasingly promote pharmaceutical products.
5. Company Response: Kaléo has been asked to provide a written response within 15 working days and to discontinue such communications or face potential distribution issues for Auvi-Q.
6. Previous Actions: This is the second untitled letter the FDA has sent to a pharmaceutical company this year, following one to Novartis in January over a misleading TV ad for Kisqali, a breast cancer treatment.
7. New Guidance: The FDA has released updated guidance on addressing misinformation, allowing healthcare companies to take proactive steps in correcting misinformation about their products on social media.