Kim Kardashian’s Social Media Posts Result in FDA Warning for Drugmaker

A series of social media posts by reality TV star Kim Kardashian promoting Duchesnay USA’s morning sickness drug landed the company an FDA warning letter because no risk information was included.

In posts on Facebook, Twitter and Instagram, Kardashian raved about Diclegis, saying she had partnered with Duchesnay to promote the drug. She told followers to ask their doctors about the drug or go to www.diclegis.com or www.DiclegisImportantSafetyInfo.com for more information.

Kardashian has roughly 100 million followers across the three platforms, so a huge audience potentially saw the posts.

The FDA’s Office of Prescription Drug Promotion is concerned because the posts present various efficacy claims, but omit all risk information. Directing followers to the company’s websites doesn’t mitigate the omission, which suggests that the drug is safer than has been demonstrated, the Aug. 8 warning letter says.

Diclegis (doxylamine succinate and pyridoxine hydrochloride) is contraindicated in women with known hypersensitivity to the active ingredients in the drug, other ethanolamine derivative antihistamines and in women taking monoamine oxidase inhibitor antidepressants. It also has not been studied in women with hyperemesis gravidarum, a complication that affects up to 2 percent of pregnant women.

OPDP told the Rosemont, Pa., drugmaker to halt the posts and devise a plan for posting corrected messages on Kardashian’s social media sites for the same duration of time the originals were posted.

Duchesnay says it is addressing the issue.

View the social media post www.fdanews.com/08-13-15-KardashianPosts.pdf. The warning letter is www.fdanews.com/08-13-15-DuchesnayWarning.pdf. — Kellen Owings