The FDA has issued a warning letter to the maker of Diclegis, a morning sickness drug that Kim Kardashian promoted on her Instagram account.
The U.S. Food and Drug Administration (FDA) isn’t thrilled about a drug endorsement that Kim Kardashian circulated to her 42 million followers last month.
The expectant reality star, 34, recently announced her partnership with pharmaceutical company Duchesnay USA on Instagram to promote a prescription treatment for pregnancy nausea called Diclegis. The problem? She didn't outright mention key safety information about the pill’s possible side effects with the photo. (The post has since been removed, but you can view a screengrab, via Forbes.)
"I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor," the original post said. "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."
On Tuesday, the FDA shared the warning letter issued Aug. 7 to the CEO of the Canadian drug company, which states that Kardashian’s endorsement post "is false or misleading" for failing to include any risk information associated with use of the drug.
Kardashian's caption advised followers to consult a doctor and to visit the official website, along with a Diclegis safety information webpage, for more information. But the note went on to order the company to remove Kardashian’s social media messages immediately and provide a written response to the FDA about how they plan to avoid future violations by Aug. 21.
Duchesnay USA responded in a statement to the Associated Press, confirming that it "will take quick action in responding to the FDA's letter and immediately and effectively address any issues."
The FDA approved Diclegis in 2013. Marked by a purple pregnant woman on the little while pill, it's a delayed-release drug made up of a combination of two substances, the antihistamine doxylamine and vitamin B6. It is prescribed to pregnant women suffering extreme nausea who do not respond to traditional morning sickness treatments.