It looks like Kim K. is at the center of a government drug regulation scandal.
The TV celebrity, who is pregnant with her second child, took to Instagram to share a glowing testimonial about a morning sickness drug last month. But the FDA has ordered the drug’s manufacturer to take the post down.
Kardashian is a spokeswoman for the drug, DICLEGIS, which is made by Duchesnay USA.
“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. [My doctor] prescribed me #Diclegis. I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby,” Kardashian wrote to her 42 million Instagram followers. She also tweeted the post to her more than 34 million followers on Twitter.
In a letter dated August 7, the FDA ordered the drug’s makers to take the post down.
“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 letter reads.
DICLEGIS is intended for the treatment of nausea and vomiting in pregnant women who do not respond to other ways of managing these symptoms. But the drug has not been studied in women with severe morning sickness, or hyperemesis gravidarum, and is not recommended for women taking certain kinds of allergy medications or antidepressants.
The drug also comes with a warning about activities requiring mental alertness, and the most common side effect is drowsiness.
The FDA’s letter calls for Duchesnay to “immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce,” as well as a written response describing how it will spread “truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.”
Laney Landsman, a spokeswoman for Duchesnay, confirmed that Kardashian’s posts had been removed immediately, The Washington Post reported.
Given the fact that you can only convey a certain amount of information in a given space, social media poses a challenge for accuretely communicating information about drug safety. And due to safety disclosure requirements, a lot of companies have steered clear of using it entirely.
But that doesn’t stop individuals from spreading questionable information.
“Outside of a promotional context, Kim Kardashian, if she jumped on Twitter and made these statements, and had absolutely no relationship to the company, that would be fine,” Kevin Madagan, counsel at Reed Smith, told the Post. However, “You need to be careful about how you go about doing it,” he said.
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