It’s probably the most-liked mea culpa on Instagram. Kim Kardashian's correction to an ad for a morning sickness drug she posted earlier this much – prompting a run-in with the Food and Drug Administration – amassed more than 370,000 likes and nearly 7,000 comments on Monday. And counting.
Federal regulators pounced earlier this month when Kardashian posted an endorsement of a morning sickness pill on her social media accounts, which reach tens of millions of followers.
“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad,” Kardashian wrote on an Instagram post that she also linked to on Twitter, showing her staring at the camera as she held up a pill bottle of Diclegis, made by Duchesnay USA.
The FDA quickly wrote to the company, ordering the removal of the post, which it called “false or misleading” because it promoted the drug without including any information about its potential risks.
Among the things Kardashian neglected to mention: The drug hasn't been studied in women with a rare complication of pregnancy that causes extreme morning sickness. It's not recommended for women sensitive to various drugs. And the drug label comes with warnings and precautions for activities requiring mental alertness.
Kardashian, a paid spokeswoman for the company, quickly removed the Instagram post, and a Duchesnay representative said the company was “working very hard to take quick action in responding to the FDA’s letter.”
Fast forward a couple weeks. Kardashian has now posted what’s known as a “corrective” ad to her millions of social media followers. On Instagram, it includes the same picture as before, but this time with a lengthy safety warning.
“#CorrectiveAd I guess you saw the attention my last #morningsickness post received,” she wrote. “ The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis.”
The post goes on to describe a sizeable list of precautions and potential side effects of the drug, including potential drowsiness and the need to avoid alcohol or other central nervous system depressants while taking the medication.
By Monday afternoon, Kardashian’s corrective post on Instagram had amassed 370,000 likes.
Kevin Madagan, a lawyer at Reed Smith with no relationship to the case, said the post does address the FDA's concerns -- she included the side effect information and posted the correction in the same social media feed where it originally appeared.
But he said the thousands of comments also raises another interesting question about using these channels to make claims about drugs. Does Kardashian, as a spokesperson for the company, have an obligation to sift through the thousands of comments to make sure that there are no off-label claims being made about the drug?
Typically, he said, when drug companies post promotional material on social media channels such as YouTube, or on a blog, they disable comments. Spokespeople talking in front of an audience are supposed to make corrections if someone makes a claim a drug can be used off-label.
"What you would do is the spokesperson would be required to say that is an off-label statement, and the product is not indicated for that use, and please see the full prescribing information," Madagan said.
And not all of her followers seem to understand that she was a spokesperson, which isn't included in this post.
"I wonder if she got paid to post this," alxcelx wrote.