US Celebrity Kim Kardashian's Social Media Posts Violate Regulations, FDA Issues Warning Letter

U.S. celebrity Kim Kardashian’s social media posts violate regulations, FDA issues warning letter

Kim Kardashian who is a model, actress, entrepreneur, socialite and star of the reality show ‘Keeping Up With The Kardashians’, has her posts on social media promoting the drug Diclegis, result in the US Food and Drug Administration (FDA) issuing a warning letter recently.

The reality TV star shared a selfie of herself, on Instagram and Twitter, holding a bottle of Diclegis, a prescription-only drug used to treat nausea and vomiting during pregnancy.

The posts violated FDA’s drug-promotion regulations and the warning letter was issued to Duchesnay USA, the company which produces the drug. The FDA’s warning letter said the media posts did not communicate the medical risks of the drug.

Viral Communication

Kardashian’s posts, told over 40 million followers that Diclegis (doxylamine succinate and pyridoxine hydrochloride) made her feel “a lot better” and worked after everything else her doctor recommended had failed to cure her morning sickness. In addition she said, “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…,” the post added, and was liked over 450,000 times. Kardashian’s post was pre-approved by Duchesnay, with whom Kardashian “partnered” to raise awareness about morning sickness.

What Kardashian failed to mention

“The social media post is misleading because it presents various efficacy claims for DICLEGIS, but fails to communicate any risk information,” says the FDA warning letter. According to its FDA-approved product labeling, DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

The FDA also issued the warning letter for omitting material facts as the drug has not been studied in certain populations of women. Diclegis has not been studied in the about 1 percent of women who undergo dangerously severe vomiting called hyperemesis gravidarum, the condition that made headlines last year when in Britain, Prince William's wife Kate was briefly hospitalized.

A different version of the drug, Benedictin was taken off the market in 1983 following a series of lawsuits alleging links to birth defects. The decision taken by Merrell Dow Pharmaceuticals, to stop selling Bendectin, was driven by commercial reasons because the company's insurance premiums had soared to US $ 10 million a year, only US $ 3 million less than the income from the sale of the drug.

However, subsequent FDA investigations never established any link between the drug and the reported problems.

All in the family

The promotion was also a family affair. Duchesnay said Kardashian’s mother, Kris Jenner, also a paid spokeswoman, shared Kardashian’s social media posts on her own accounts. Jenner tweeted, "#SPONSORED Glad @KimKardashian is feeling better, wish I had something like this product during all my pregnancies! (sic)"

As an expected corrective action, in the letter sent to the Executive Vice-President of Duchesnay, the FDA has mentioned that “corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated”.

Diclegis has been available in Canada under the trade name Diclectin® for more than 30 years as the only prescription drug specifically indicated and approved for the management of nausea and vomiting of pregnancy (NVP). The product is a delayed-release combination of an old antihistamine and a form of vitamin B₆ (doxylamine succinate and pyridoxine hydrochloride) designed to help women take a daily dose before their nausea sets in.

Thankfully, the 34-year-old Keeping Up With the Kardashians star's doctor had prescribed her Diclegis.

Although the FDA may not be happy about the posts, the advertisements have been a resounding success. AdWeek assessed the controversy will help the company in the long run, since more people have now heard of Diclegis.

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