FDA: Lack Of Info In Kim Kardashian’s Endorsement Of Morning Sickness Pill Puts Consumers At Risk

delayed-release-action-graphWhile celebrities get special treatment most places they go, there is no VIP pass that allows them to endorse a prescription drug without disclosing its associated risks and limitations. So when mom-to-be Kim Kardashian used social media to sing the praises of a morning sickness pill, it raised a red flag for federal regulators.

The Food & Drug Administration sent a warning letter [PDF] to Duchesnay, the company behind the morning sickness pill Diclegis, notifying the maker that it must discontinue using Kardashian’s social media endorsements because it doesn’t adequately address risk factors associated with the use of the pills

Diclegis, which was approved in 2013, is intended to treat nausea and vomiting of pregnancy in women who do not respond to other conservative management.

According to the FDA letter, a review of the endorsement by Kardashian found the posts to be “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.”

As a result, the FDA claims the post misbrands the pill, which makes its distribution a violation of the Federal Food, Drug, and Cosmetic Act.

Kardashian posted her endorsement of the pills through her Twitter, Instagram and Facebook accounts in mid-July. They have since been taken down, with the exception of a dead link on Twitter.

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According to the FDA letter, the endorsement included the following claims:

OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. 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. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more http://www.diclegis.com; http://www.DiclegisImportantSafetyInfo.com.

While endorsement post included links to the company’s website and Duchesnay sent out a press release providing more details about the partnership including information on Diclegis, the FDA claims those steps weren’t enough to mitigate misinformation.

“The social media post, however, entirely omits all risk information,” the FDA letter states. “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.”

The FDA gave Duchesnay until Aug. 21 to submit a written response on whether it plans to comply with the agency’s request by submitting all promotional materials and a plan to discontinue misbranding or simply cease distribution of Diclegis.

A spokesperson for Duchesnay tells Bloomberg that the company acknowledges its promotional materials need to be in accordance with FDA rules and regulations and that it would “immediately and effectively” addressing any issues.

According to the FDA letter, this isn’t the first time Duchesnay has been in trouble for promotional materials related to Diclegis. Back in 2013, the FDA sent a warning regarding its announcement of the drug, which allegedly omitted risk information and limitations of the medication.

[via Bloomberg]