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September 01, 2015

How Kim Kardashian's Instagram got a Rosemont drug company in trouble with the FDA

Drugs Kim Kardashian
Kim Kardashian Diclegis Contributed Art/Instagram

Rosemont company Duchesnay USA got in trouble with the FDA after Kim Kardashian endorsed their morning sickness drug on Instagram.

Followers of social-media superstar Kim Kardashian expect to see selfies and perhaps a few pictures of her and husband Kanye West on her Instagram account. Instead, they got a 300-word report on the side effects of the morning sickness drug Diclegis, produced by a local drug company.

Why did Kardashian's Instagram turn into the fine-print part of a drug commercial? An early social media endorsement of Diclegis, got its maker, Rosemont-based pharma company Duchesnay USA, into trouble with the Food and Drug Administration.

In July, Kardashian posted to her 44.8 million Instagram and 34.9 million Twitter followers: "OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad...I talked to my doctor. He prescribed me #Diclegis." Of course, she also included a selfie of her holding a bottle of the morning sickness pills.

Problem is, unlike your average morning sickness sufferer who recommends a product online, Kardashian is a celebrity and is paid to endorse products. The post ran afoul of the FDA, since it failed to mention important information like the drug's side effects or the fact that women shouldn't use the pills if they are breastfeeding.

"The social media post is 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," the agency wrote in a warning letter to the company.

"In the original post, which we developed with Kim, we provided her with a link to risk information and limitations of use for Diclegis, but this post did not meet FDA requirements for communicating important product information," said Duchesnay's General Manager Dean Hopkins in a statement.

So on Monday Kim had to post a long #CorrectiveAd.

A precursor to Diclegis called Bendectin, manufactured by Merrel Dow, was voluntarily taken off the market over 30 years ago because of lawsuits claiming that the pill caused birth defects. However, the FDA approved the drug under the trademark name Diclegis in 2013 after extensive testing showed no risk to the fetus.

This isn't the first time that the FDA has paid attention to social media. Thomas Abrams, director of the Office of Prescription Drug Promotion, noted in an interview that social media makes it more complicated than ever to monitor promotions for drug materials.

"The Internet and social media have increased the volume and extent of materials and speeded the delivery of those materials. Web sites can have hundreds of pages and can change daily," he said.

He also noted that the FDA can only take action against a company or somebody working on behalf of the company. If Kim Kardashian was inspired to write about Diclegis all on her own, rather than being paid for an endorsement, then the company would not be in trouble.