When Kim Kardashian West's July 20 Instagram post (now removed) went up telling followers that her morning sickness was relieved by Diclegis, I wrote that her endorsement was very carefully worded to stay in compliance with prescription drug promotion, as prescribed by the Food and Drug Administration. As shown below, Kardashian was careful to follow her testimonial with a link to the drug's primary information page and another to a prolonged list of safety information.
But the FDA's Office of Prescription Drug Promotion has ruled in a warning later dated last Friday, August 7, that those URLs were insufficient and inconsistent with the full material information required when such a drug is advertised in any medium. It turns out that this wasn't just a happy celebrity sharing her health tips with her 464,000 40.8 million closest friends (the post alone received 464,000 likes).
The OPDP became involved because the post was a paid endorsement to Kardashian West by the drug's maker and, as required, had been submitted in advance to the Office for review. And as a piece of trivia, I believe this is the first time that an FDA warning letter has contained the acronym OMG.
The introductory summary of the warning letter states,
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. Thus, the social media post misbrands DICLEGIS within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. . . These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated.
Diclegis is a delayed release form of doxylamine succinate, a well-studied antihistamine with antinausea properties, and pyridoxine hydrochloride. Made by Duchesnay USA of Rosemont, Pennsylvania, Diclegis received FDA approval in 2013 for the treatment of uncomplicated nausea and vomiting of pregnancy (NVP) when lifestyle and dietary changes have been unsuccessful. The drug is NOT approved for women with the very severe form of pregnancy nausea and vomiting, hyperemesis gravidarum, and this point was not made in Kardashian West's post. The same formulation is sold in Canada as Diclectin.
Related - The Kim Kardashian-Endorsed Morning Sickness Drug Is The Real Deal
The warning letter, written by FDA OPDP Division Director Robert Dean to Duchesnay's EVP Eric Gervais elaborated:
The social media post, however, entirely omits all risk information. We note the statement, “[F]ind out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com[,]” appears at the end of the social media post; however, this does not mitigate the misleading omission of risk information. 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.
The side effects of Diclegis are certainly noteworthy, but not uncommon. As with many older antihistamines, doxylamine can cause considerable drowsiness that's intensified any other central nervous system depressant, side effects that should've been accompanied by a warning about operating machinery or motor vehicles. These older drugs also have anticholinergic effects, meaning that they block the slowing effect of our own acetylcholine on heart rate, and can have adverse reactions on the heart when used with monoamine oxidase inhibitor drugs often still used to treat depression.
Oops, I did it again
But the tone of Dean's letter – and the fact that it comes directly from the division's director – suggests that he is not at all amused. He cites specifically the 2013 warning letter his division issued to the company when it announced the approval of Diclegis, also with inadequate safety information.
False or misleading promotional materials by Duchesnay are particularly troubling considering OPDP expressed concerns regarding violative promotional activities for DICLEGIS as recently as November 2013. On November 12, 2013, OPDP sent Duchesnay an Untitled Letter regarding a letter announcing the approval of DICLEGIS. The letter cited in the Untitled Letter was false or misleading because, among other concerns, it omitted all risk information and omitted material facts regarding DICLEGIS’ important limitation of use. OPDP is concerned that Duchesnay is continuing to promote DICLEGIS in a violative manner.
One doesn't have to be a specialist in regulatory affairs to recognize this company, and others, should pay particularly close attention to any drug advertising via social media.
When contacted for comment by email, Laney Landsman, Duchesnay USA spokeswoman, responded, "Duchesnay USA takes its regulatory responsibilities very seriously, and acknowledges that its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations. We will take quick action in responding to the FDA’s letter and immediately and effectively address any issues. We appreciate the FDA’s objective of ensuring that promotions remain consistent with approved labeling and fully support this objective."
Buried in on page 3 of the FDA's request for corrective action and point-by-point company response is the statement, "To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated."
So does this mean that the company will have to strike up another deal with Kardashian West to put up another Instagram post?
The Duchesnay spokeswoman replied, "We will have to work with the FDA to determine if that is an appropriate action."
Your move, Kim.
This post has been updated since the original posting to note that Kardashian West's endorsement pictured here has been removed from the Instagram site. The spelling of hyperemesis gravidarum has been corrected and a link provided to the disorder at Medline Plus Medical Encyclopedia of the National Library of Medicine.
