FDA issues warning over Kim Kardashian’s drug promotions

Well, I was wrong.

In July, Kim posted a photo on Instagram promoting a “partnership” with the drug Diclegis, which helps combat morning sickness. As shown below, Kardashian was careful to follow her testimonial with a link to the drug’s primary information page and another to a prolonged list of safety information.

The FDA says all this should have been somewhere in Kardashian’s posts-or that she shouldn’t have posted them at all. It turns out that this wasn’t just a happy celebrity sharing her health tips with her 464,000 closest friends.

The FDA posted its warning letter online, addressed to the CEO of Canadian drugmaker Duchesnay Inc., which markets the drug. Duchesnay said Kardashian’s mom Kris Jenner, also a paid spokeswoman, shared Kardashian’s social media posts on her own accounts.

The drug is a combination of pyridoxine and doxylamine.

Diclegis is indicated for women who don’t respond to more conservative measures to address morning sickness, such as eating more small meals or bland foods.

Kardashian, who is marrried to rapper Kanye West, has talked about her struggles with nausea due to pregnancy in posts to Instagram and Facebook. The same formulation is sold in Canada as Diclectin.

The agency said that the hyperlink alone was not enough to “mitigate the misleading omission of risk information…and suggests that it is safer than has been demonstrated”.

The FDA, in a letter posted on the agency’s website, warns that the reality TV star’s social media posts about the drug, Diclegis, fail to communicate any risk information associated with the medicine.

The side effects of Diclegis are certainly noteworthy, but not uncommon. It can also cause severe drowsiness. On November 12, 2013, OPDP sent Duchesnay an Untitled Letter regarding a letter announcing the approval of DICLEGIS. They called the ad “false and misleading” for leaving out key facts about which drugs to avoid while taking Diclegis. Which, absent any potential fines, must seem like a buy-1-get-1-free deal from the perspective of the drug company.

In a letter dated August 7, the FDA ordered the drug’s makers to take the post down.

Kardashian’s publicist did not immediately respond to a request for comment Tuesday.

Kim Kardashian has shilled for a wide variety of different products, including diet pills and Silly Bandz.

The Duchesnay spokeswoman replied, “We will have to work with the FDA to determine if that is an appropriate action”.