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Kim Kardashian– Caves to FDA Over Morning Sickness Endorsement
Reports say that FDA sent Kim Kardashian a warning letter in mid-August citing the fact that she needed to include proper medical information when posting anything that includes a prescription drug.
On Sunday night, while the rest of the entertainment world was focused on the , Kim Kardashian West took to social media for another reason: to belatedly acknowledge the side effects of a controversial morning-sickness drug she endorses.
Weeks before the Instagram post of Kanye’s pregnant wife, the FDA issued a warning letter to Duschesnay, Inc. executive vice president Eric Gervais about Kardashian’s promotion of the morning-sickness medication Diclegis on Instagram.
Kevin Madagan, an attorney for the law firm Reed Smith, said drugmakers are cautious about advertising on social media because space limitations make it hard to include risk disclosures.
Kardashian first praised the medication in July posts, broadcast to her millions of followers, that started with “OMG”. The FDA also asked that the new post “be distributed using the same media”.
The “Keeping Up With The Kardashians” star wrote to her account, “I guess you saw the attention my last #morningsickness post received”.
Kim Kardashian has-been forced to repost her arguable twitter site message relating to a morning illness drug after it was deemed deceptive.
Madagan noted that while the updated post appears to adhere with FDA’s request, the thousands of comments on the post raises other concerns.
The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts…
The FDA has came after Kim and the drug’s manufacturer, Duchesnay, for providing incomplete and misleading information about Diclegis or doxylamin succinate pyridoxine HCl. “I guess you saw the attention my last #morningsickness post received”, the post reads. For US Residents Only.
The remainder of Kardashian’s publish was the type of boilerplate danger info that voice actors velocity by way of within the ultimate seconds of TV drug advertisements: “Diclegis has not been studied in ladies with hyperemesis gravidarum”, or excessive, persistent vomiting.
She failed to mention any of the drug’s side effects or contraindications – for example, that the drug has never been studied in women who suffer from a pregnancy complication called hyperemesis gravidarum, and that some women should not take Diclegis because of allergies to certain ingredients or unsafe interactions with other drugs. It warns against drinking alcohol, operating heavy machinery or doing other things requiring one’s full attention. Severe drowsiness can happen or become worse causing falls or accidents. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
