Kim Kardashian is pregnant with her second child, and in her typical fashion she has been sharing updates about her condition through social media. Last month, the reality television star posted a picture of herself holding a bottle of Diclegis, a medication used to treat morning sickness:
“As you guys know my #morningsickness has been pretty bad,” wrote Kardashian to her 42 million Instagram followers in a post that has now been removed. She shared her enthusiastic review of the drug, which she said helped relieve her symptoms so well she decided to partner with the maker, Duchesney USA, to “raise awareness about morning sickness.”
In her post, which Kardashian also shared on Twitter, where she is followed by over 36 million, she claims that “most importantly, it’s been studied and there was no increased risk to the baby.”
What Kardashian did not do, however, was include information about risks and side effects connected with the drug, as required in advertising for it. These include warnings about drowsiness and operating heavy machinery; the drug’s possibly harmful interactions with other drugs, and with certain allergy and medical conditions; and a warning not to breastfeed while taking the drug.
The US Food and Drug Administration (FDA) was not pleased with this omission, and on Aug. 7 released a warning letter to Duchesney, accusing the post of “misbranding.” The letter notes that “the social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts.”
The FDA goes on to complain in detail about the wording of the post:
Duchesney has not responded to Quartz’s request for comments. In astatement to Forbes, a spokeswoman said: “Duchesnay USA takes its regulatory responsibilities very seriously, and acknowledges that its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations. We will take quick action in responding to the FDA’s letter and immediately and effectively address any issues.”
The post has been removed from Kardashian’s Instagram feed (althoughthe tweet remains online), but that might not be enough: The FDA letter has requested that “corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated.”
This means that Kardashian may need to post a new picture to replace the old—this time with all the required disclaimers.