Here's Why The FDA Is Mad At Kim K.

Photo: Andrew Parsons/REX Shutterstock.
Update: Kim has now reposted her Instagram photo along with a whole heap of safety information (and #CorrectiveAd) in order to appease the FDA. Continue to our original story below to learn more about the original post and why the agency wasn't too pleased with it.

This article was originally posted on August 12, 2015.

Although every detail regarding Kim Kardashian West's unborn child has seemingly entered the public conscious, we can't say we ever expected her pregnancy to show up in a warning letter from the Food and Drug Administration (FDA). But, after Kim promoted a drug used to treat morning sickness on her Instagram, the agency had words, reports Forbes.

The drug in question is Diclegis, which is FDA-approved to treat morning sickness in women who haven't responded to traditional tactics — including the diet and lifestyle changes Kim called out in her post. She did also specifically mention that interested readers should talk to their doctors, and she posted the URL where they could learn more — both important things to include. But the FDA's Office of Prescription Drug Promotion wasn't too happy with the fact that Kim left out some crucial details about the drug's potential side effects (which include the severe drowsiness typical of some antihistamines).

In a warning letter sent last week to Duchesnay, the drug's manufacturer, the office first dryly recounts the entire post. Then, it asserts that this omission makes the post misleading and potentially harmful:

By omitting the risks associated with DICLEGIS, the social media post misleadingly fails to provide material information about the consequences that may result from the use of the drug and suggests that it is safer than has been demonstrated.

Additionally, the post left out the fact that, while Diclegis has been clinically tested in women with standard morning sickness, it hasn't been tested in the case of hyperemesis gravidarum, a more severe version of morning sickness. No, this did not please the FDA. As the organization requested, Kim took down the insta post and Duchesnay has to disseminate "corrective" materials, which (of course) may include another post from Kim.

As Ben Goldacre pointed out on Twitter, the timing here is a bit ironic: This is all happening the same week that we lost Frances O. Kelsey, MD, PhD. She was the extremely persistent FDA officer responsible for getting all the data on the morning sickness drug thalidomide in the 1960s — which was especially important because it turned out that thousands of babies were born with severe defects after their mothers used the drug. Through Dr. Kelsey's tireless efforts, thalidomide was never approved for this use in the U.S. These events also caused the FDA to revamp its clinical testing requirements, which now require companies to show evidence that their products are both safe and effective before they are made available to consumers.

But, as Forbes points out, we should not let ourselves forget that the FDA archives will now forever contain the word "OMG," thanks to this warning letter. What a time it is to be alive.
Photo: Via Forbes.
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