OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian devotee apparently works at the U.S. Food and Drug Administration (FDA), which sent a warning letter to Duchesnay, Inc., the company that manufacturers Diclegis, concerning Kim’s post.

In its August 7 letter, FDA warns that the social media post is false and misleading because it presents efficacy claims for Diclegis but fails to communicate any risk information associated with the drug’s use. The post, helpfully reproduced by FDA here, proclaims various benefits of the drug, including alleviation of morning sickness symptoms. It ends with a web address that, by its appearance, may contain safety information for the drug.

For FDA, the web link to safety information does not satisfy regulations concerning advertising of drugs, meaning the social media post misbrands Diclegis under the federal Food, Drug, and Cosmetic Act. Specifically, the post omits the risks associated with the drug and fails to provide material information regarding Diclegis’ full approved indication, including limitations of use. Because Kim Kardashian is a paid spokeswoman for Duchesnay, FDA viewed the social media post as a false and misleading advertisement by the company.

Pharmaceutical manufacturers desiring to use social media and celebrity promotion should bear in mind FDA guidance on using the internet and social media platforms to promote prescription drugs and medical devices. In particular, FDA recommends balancing benefit and risk information in every post, meaning each individual message or tweet should present risk information together with benefit information. At minimum, FDA endorses presenting the most serious risks associated with the product, followed by a web link to further information.

The warning letter can be read here. FDA’s guidance for using social media can be found here. Kim Kardashian can be found nearly everywhere.

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