A Canadian drug company probably thought an advertisement featuring Kim Kardashian would attract new customers, but the prominent socialite and reality TV star's product endorsement also caught the attention of the Food and Drug Administration.
In her role as a paid spokeswoman for Diclegis, a morning sickness drug manufactured by Duchesnay, Kardashian raved about her success with the drug in posts on Facebook, Twitter and Instagram. But the FDA says her posts were in violation of federal rules regarding drug advertising because they promote the product's efficacy without including any information about side effects or limitations on the drug's use.
“These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated,” the agency wrote in an Aug. 7 letter to Duchesnay, which has since worked with Kardashian to remove her testimonials.
In her social media posts, Kardashian noted that her morning sickness from her most recent pregnancy has been particularly difficult, but noted that “#Diclegis” made her feel “a lot better.”
“It's been studied, and there was no increased risk to the baby,” Kardashian wrote. “I'm so excited and happy with my results that I'm partnering with Duchesnay USA to raise awareness about treating morning sickness.”
The posts included links to the Diclegis website, as well as to another site containing safety information about the drug. But without directly including any risk information, Kardashian's posts suggested that the drug is “safer than demonstrated,” according to the FDA.
The FDA wrote that it was particularly concerned because Duchesnay has been previously warned about a letter it sent to doctors announcing the drug's approval that similarly omitted risk information and material facts about the drug's limitations. The FDA warning letter may very well be the first time the agency has used the texting abbreviation “OMG” (short for “oh my god”) in formal correspondence, referring to Kardashian's posts praising the drug.
The agency told Duchesnay it must immediately cease misbranding Diclegis, and respond with a plan to prevent future marketing misperceptions. Duchesnay said in a statement that it “will take quick action in responding to the FDA's letter and immediately and effectively address any issues.”