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.

OPDP noted that Auvi-Q's approved prescription information includes warnings and precautions user should take in an emergency, potential injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. It also includes potential adverse reactions such as anxiety, apprehensiveness, restlessness, tremors, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties.

In the now-removed post, Mahomes told followers that she has an infant and a toddler with severe food allergies, and she was prescribed Auvi-Q by her pediatrician as the only epinephrine auto-injector indicated for infants and toddlers. She noted that the product is intended to treat life-threatening allergic emergencies and added that people should look up the drug's safety information online. However, agency investigators say that is not enough to educate the public about the potential risks of using the injectors.

"By omitting the risks associated with Auvi-Q, the post fails to provide material information about the consequences that may result from the use of Auvi-Q and creates a misleading impression about the drug’s safety," said OPDP.

In addition to the Instagram post, Mahomes was also mentioned in a January press release from Kaleo that included identical language about her children, the use of Auvi-Q, and more detailed safety and risk information.

FDA told Kaleo they have 15 business days to respond to the untitled letter.

Kaleo press release

FDA untitled letter

FDA dings Kaleo over Instagram post with insufficient risk information

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