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FDA issues warning over Kim Kardashian’s drug promotions

But she’s probably never faced negative publicity like this before: The Food and Drug Administration says Kardashian’s social media posts violate drug-promotion rules.

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In July, she posted a photo on Instagram promoting a “partnership” with the drug Diclegis, which helps combat morning sickness, however she didn’t mention any risks associated with the medicine. Buying a celebrity promotion on social media from Kim Kardashian is rumored to start at somewhere north of $20,000, but advertisers love to get “organic” coverage from celebrity endorsements after the fact when the message ripples through the new media ether. Last month’s posts from Kardashian, who has 42.4 million followers on Instagram and 34 million on Twitter, also didn’t include key information required by the FDA, such as which populations of pregnant women haven’t been studied for the drug’s use.

That combination of uncertainty and side effects wasn’t clearly stated in Kardashian’s post, and that was the basis of the FDA’s ruling. “Duchesnay USA takes its regulatory responsibilities very seriously, and acknowledges that its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations“, the statement said. But the FDA now calls Kardashian’s posts “false and misleading” because they omitted “all risk information”. “[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”.

Duchesnay has until August. 21 to respond to the FDA’s letter.

Kim Kardashian has shilled for a wide variety of different products, including diet pills and Silly Bandz. It is the only prescription drug approved in the U.S. for morning sickness.

The entire brouhaha appears to be a big victory for Diclegis, however, according to Treato, an Internet-based intelligence company focused on the health sector. Made by Duchesnay USA of Rosemont, Pennsylvania, Diclegis received FDA approval in 2013 for the treatment of uncomplicated nausea and vomiting of pregnancy (NVP) when lifestyle and dietary changes have been unsuccessful. As per Bloomberg, the drug is controversial because an earlier version of the compound known as Bendectin was recalled from the U.S. market in 1983 over fears that it could cause birth defects.

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Kim Kardashian's Morning-Sickness Ad Has Gotten Her in Trouble With the FDA