No “likes” from FDA on Kim Kardashian Instagram post; agency cites Canadian drug manufacturer over missing risk info

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kim kardashianAt first, a few media outlets criticized Kim Kardashian for hypocritically breaking her own 3-week-old social media promotion policy when she began plugging Diclegis, a morning sickness pill, on her Instagram account on July 20. That was no minor about face. With 40 million followers, the reality star and beauty entrepreneur has a special grade of marketing clout. Now the FDA is going after the Canadian manufacturer of the pill for bypassing marketing regulations requiring a drug maker to spell out the risks in any drug promotion. And the health news media are all over it.

In the post (which was removed from Instagram on Tues., August 11) Kardashian says:

“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more at www.declegis.com; www.DeclegisImportantSafetyInfo.com.”

The FDA’s Office of Prescription Drug Promotion has informed Duchesnay Inc., the Quebec-based drug maker, that it must take corrective action for its “misleading omission of risk information.” While the antihistamine drug received FDA approval in 2013, it is not approved for the most serious form of morning sickness called hyperemesis gravidarum. Other risks associated with Diclegis (marketed as Diclectin in Canada) include drowsiness, which is usually accompanied by a warning about driving, a slowing of the heart rate, and possible conflicts with certain types of antidepressants.

“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,” said the FDA’s OPDP director Robert Dean in his letter to Duchesnay.

It may not be possible for the company to achieve the same social media reach without contracting with Kardashian once more.

For its part, Laney Landsman, Duchesnay USA spokeswoman, told Forbes’ David Kroll that

“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.”

The prescription pills aren’t cheap. According to Medpage Today, expectant moms can expect to shell out about $570 for 100 tablets for the higher strength dose that must be prescribed by a doctor. Patients typically take two to four tablets a day. An over-the-counter version with lower amounts of the active ingredient cost from $5 to $10 for 100 tablets.

This is far from the first time a drug manufacturer has gotten into hot water over false or misleading drug advertising. Over the last 10 years pharmas have paid billions in fines for marketing wrong-doing. But this is one of the first times a drug company made such a big blunder on social media, a medium the pharmaceutical industry has been all but avoiding due to strict FDA advertising regulations.

If history is a judge, the FDA scolding probably won’t make a dent on the Kardashian brand empire. The Kardashians were sued in 2012 for misrepresenting a laxative called QuickTrim sold at CVS, Wal-Mart, Walgreens, GNC and other stores. A branded credit card – the Kardashian Kard – was retired in 2010 after the Connecticut attorney general cited the teen-targeted card for its “outrageous fees.”


Kathlyn Stone is an associate editor with HealthNewsReview.org

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fatalreview

August 13, 2015 at 2:32 pm

Hope the FDA brings the BIG Hammer-they need to nip this kind of “endorsement” in the bud and make a public example of someone well known-Kimmode is perfect for this part and needs some actual reality in her fake plastic klown face. Besides after what the FDA does to small organic farmers and ranchers?-you better do something about this far bigger threat or we know your paid off like the LA-DA on Bruce Jenners vehicular manslaughter-get a grip boys

Judith Ronat M. D.

August 17, 2015 at 7:25 am

A drug for morning sickness? It is more than 50 years since the FDA protected American pregnant women and their babies from thalidomide. I can’t see how anyone would take a pill for it.

As for hyperemesis gravidarum, more than half a century ago, a school chum had hyperemesis gravidarum. The doctors didn’t look for a cause, and for fear of radiation to her fetus, they didn’t x-ray her. She died of a stomach cancer. Let’s examine the patient before we treat the symptoms!