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Megastar Kim Kardashian West's foray into pharmaceutical advertising didn't just catch the interest of fans — it also drew the ire of the US Food and Drug Administration (FDA).
In response to an Instagram-based ad for Diclegis (doxylamine succinate and pyridoxine hydrochloride), a morning sickness drug manufactured by Duchesnay Inc., the FDA has issued an official warning citing the ad's failure to list any health risks tied to the product. In addition to the potential for causing heavy drowsiness, Diclegis hasn't been tested in women with hyperemesis gravidarum, which can be responsible for nausea and vomiting.
"By omitting the risks associated with Diclegis, the social media post misleadingly fails to provide material information about the consequences that may result from the use of the drug and suggests that it is safer than has been demonstrated," wrote Robert T. Dean, director for the FDA's Office of Prescription Drug Promotion (OPDP), in the warning letter.
While Duchesnay Inc. wouldn't divulge detailed information about its business relationship with Kardashian West, the FDA explained that its jurisdiction stemmed from the fact that she was representing the company.
As OPDP Director Thomas Abrams explained to the Times in 2013, "It is important to know that although we closely monitor what companies say, we generally do not have authority over statements made by independent organizations or persons — what we call third parties — unless they are acting on behalf of a company."
In this instance, Kardashian West was apparently operating in cooperation with the company. Her post has subsequently been removed, and the firm behind it has clarified its stance in a statement.
