USA – FDA dings Kaleo over Instagram post with insufficient risk information

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has handed drugmaker Kaleo an untitled letter for failing to disclose risks associated with its epinephrine auto-injector Auvi-Q in a paid-partnered social media post with Brittany Mahomes, an influencer and co-owner of the Kansas City Current soccer team.

The letter, dated 17 July, noted that Mahomes, who has children with peanut allergy, posted an Instagram reel about the benefits of using Auvi-Q in an emergency. However, the agency said the post did not provide any information about the drug’s potential adverse effects.

« This post is false or misleading in that it presents information about the benefits of Auvi-Q but fails to include any risk information about the drug, » said FDA…