FDA warns drugmaker over Kim Kardashian West promo
pharmafile | August 12, 2015 | News story | Sales and Marketing | Diclegis, Duchesnay, FDA, kim kardashian
Model and media personality Kim Kardashian West’s social media promotion of the morning sickness drug Diclegis has landed its producer Duchesnay in trouble with the FDA.
Following a review, the Office of Prescription Drug Promotion (OPDP) of the FDA wrote to Duchesnay executive vice president Eric Gervais, saying the Instagram and Facebook posts from July were false or misleading.
The OPDP says the posts “fail to communicate any risk information associated with its use and it omits material facts”: in other words, do not point out adverse side effects of the drug.
Kardashian West’s posts, which have since been removed from the sites, pictured her holding a bottle of the medication and read: “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. I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”
Although Kardashian West goes on to warn readers to check with their doctor before taking Diclegis, the FDA’s view is that the omission of side effects including somnolence and risks from the fact that the drug has not been studied in women with hyperemesis gravidarum (severe vomiting associated with morning sickness) constitutes a misleading promotion and a misbranding of Diclegis, portraying it as “safer than has been demonstrated.”
Duchesnay must respond to the FDA’s letter, dated 7 August, by 21 August, and will be obliged to correct the message, displaying all side effects and risks, via the same sites as used in the original promotion. Kardashian West may again be enlisted to disseminate the correct information.
Joel Levy
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