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FDA issues warning over Kim Kardashian's drug promotions

FDA issues warning over Kim Kardashian's drug promotions
The FDA says Kim Kardashian’s remarks omitted risk and usage details for prescription pill Diclegis. The star is seen here in June. (Lionel Cironneau / Associated Press)

Reality TV celebrity Kim Kardashian shares a slew of personal details on social media. But her post praising a pregnancy drug didn’t share enough details for the U.S. Food and Drug Administration.

The agency has ordered a Canadian drug company, Duchesnay, to remove a post from several social media accounts that Kardashian wrote as a paid spokesperson for the drug.

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The agency said Kardashian’s remarks omitted risk and usage details for prescription pill Diclegis.

“These violations are concerning from a public health perspective because they suggest that Diclegis is safer than has been demonstrated,” wrote Robert Dean of the FDA’s Prescription Drug Promotion office in a letter issued Friday.

The document, publicly released Tuesday, says any promotion of the pill must list risk information, such as noting that it has not been studied in women with a severe vomiting condition.

At issue are remarks Kardashian made on Facebook, Instagram and Twitter, where she has a total of more than 100 million followers. Her post about Diclegis, which aims to help pregnant women overcome nausea and vomiting, describes how she discovered the pill.

Kardashian, who is pregnant with her second child with husband Kanye West, wrote: “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.”

Kardashian then linked to the safety information page of the drug's website, but that wasn't sufficient for the FDA.

Her representative, Ina Treciokas, said Kardashian removed the posts Monday.

“Kim gave her personal experience and ran this statement by the company, and the company signed off on it,” Treciokas said. “Any additional questions should be directed at the company.”

Duchesnay was ordered to submit a letter to the FDA by Aug. 21 outlining plans to prevent future violations.

The company said in a statement Tuesday that it would “effectively address any issues.”

Seeking to address the growing use of social media such as Twitter, which offers space to publish 140 characters, the FDA released suggestions last year on how social media should be used to promote FDA-regulated medical products.

daina.solomon@latimes.com

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