The regulator issued a warning letter stating Kardashian’s endorsement of the company’s Diclegis pill on social media was misleading because she failed to include risk information and limitations of use.
As reported by RAPS, in July, Kardashian posted a photo of herself to Instagram with the following accompanying text:
“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.”
Diclegis is indicated to treat nausea and vomiting in pregnant women, and is contraindicated in women with “known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any active ingredient in the formula, as well as women who are taking MAOIs.” The PI also notes the drug wasn’t studied in women with hyperemesis gravidarum. The PI for the drug also contains warnings about activities that require mental alertness and concomitant medical conditions, and notes somnolence as the most common adverse reaction reported. The FDA issued a warning letter to Duchesnay, citing a number of claims included in Kim Kardashian’s Instagram post for Diclegis, writing that the post is misleading because while it contains efficacy claims about the drug, it omits all risk information. The letter notes that the statement “find out more www.diclegis.com;www.DiclegisImportantSafetyInfo.com,” which appeared at the end of the post, failed to mitigate the deceptive omission of risk information. The post excludes material information about the possible consequences of using the drug, and thus misleadingly implies it is safer than has been shown, the FDA wrote.
The letter also targets the post’s failure to provide material information about Diclegis’ full approved indication, specifically failing to convey that the drug hasn’t be studied in women with hyperemesis gravidarum.