Kim Kardashian has fallen afoul of the same rule that launched a million Cialis jokes.
In her postings endorsing a morning sickness drug, Kardashian failed to include the social media equivalent of the drug's disclaimer — those rat-a-tat warnings tagged on to television or radio ads for a drug, the ones that speed by so quickly, you almost can’t make out that this-drug-may-cause-drowsiness-constipation-delirium-and-call-your-doctor-if-your-erection-lasts-four-hours-or-longer.
It’s the Food and Drug Administration that requires those notices. But how do you translate those wordy warnings into a 140-character tweet?
The FDA is in fact poised to release new guidance telling companies and their celebrity contractors just how to go about posting these endorsements.
The agency has scolded drugmaker Duchesnay for Kardashian’s social media campaign endorsing its drug Diclegis, sold to treat the mild nausea that many pregnant women suffer. It didn’t say enough about the drug’s side-effects, the FDA said.
“The social media post, however, entirely omits all risk information."
“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, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby,” Kardashian’s breathless posts read.
She does link to the safety warnings at www.DiclegisImportantSafetyInfo.com.
“The social media post, however, entirely omits all risk information,” the FDA wrote in its warning letter to Duchesnay. Linking to the safety information isn't enough, FDA says.
That list of risks is very long, by the way.
“The most common side effect of Diclegis® is drowsiness. You should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis® until cleared to do so by your healthcare provider,” the warning insert notes.
“Diclegis® should be used with caution in women who have: (1) asthma, (2) increased pressure in the eye, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction,” it adds.
“Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest.”
Leaving out these details can mislead people, the FDA said.
“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 warning letter reads.
How can you fit all that stuff into a short post? Draft guidance from the FDA tells you precisely how, in a hypothetical posting about a drug called “NoFocus”.
“Once you are paid, you are under FDA rules.”
Here’s a suggested Tweet for such a drug: “NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]”
Thomas Abrams, director of FDA’s Office of Prescription Drug Promotion, notes the Internet means speedy delivery of reams of information, updated daily and even hourly.
“We understand that communicating on electronic Internet sites with character space limitations can be challenging,” Abrams writes in a blog post. “But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information. And companies should provide a way for consumers to gain direct access to a more complete discussion of risks associated with their products.”
By the way, if Kardashian had just decided on her own to tell her followers about the drug, she wouldn’t have gotten in trouble.
“We all have first amendment rights and can say whatever we want — but once you are paid by a company it’s the manufacturer who has to make sure the information is accurate and not misleading,” former FDA commissioner Dr. David Kessler told NBC news.
“Once you are paid, you are under FDA rules.”
