The FDA has condemned Kim Kardashian’s promotion of morning sickness prescription drug Diclegis on social media.
Kim Kardashian, who is 5-month pregnant with her second child, posted a selfie last month holding up a branded bottle of the pills alongside text endorsing their effects.
Diclegis maker, Canada-based Duchesnay, later confirmed it had compensated Kim Kardashian for “sharing her experience”.
However, the FDA has attacked the posts for failing to flag potential side effects.
The agency has ordered the drugmaker to stop promoting its product in this manner.
Kim Kardashian’s posts talked of her own use of the drug Diclegis, before stating: “Most importantly, it’s been studied and there was no increased risk to the baby.”
The 34-year-old reality star provided a link to the pharmaceutical company’s own realted safety warnings, but did describe the potential risks herself.
One side effect of a normal dose of Diclegis is drowsiness. An overdose can cause vertigo, mental confusion and an abnormal heart rate.
“The social media post is misleading because it presents various efficacy claims for Diclegis, but fails to communicate any risk information,” FDA division director Robert Dean wrote in a complaint to Duchesnay.
“Because the violations described above are serious and repeated, we request, further, that your submission includes a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audiences that received the violative promotional materials.”
Robert Dean added that the correction should be distributed “using the same media” as the original messages, indicating that the warnings should appear on Kim Kardashian’s social media accounts.
Kim Kardashian’s selfie has since been deleted from Instagram and Facebook – although a tweet alluding to the posts remains online.
Duchesnay said that it would issue a formal response ahead of a August 21 deadline.
The Food and Drug Administration (FDA) says Kim Kardashian’s social media posts violate federal drug-promotion rules.
Kim Kardashian, who is 5 months pregnant with her second child, recently began promoting a prescription pill to treat morning sickness through her social media accounts. Such endorsement deals are relatively common for celebrities.
In posts to Instagram and Facebook earlier this month Kim Kardashian talks about her struggles with nausea due to pregnancy.
The reality star wrote: “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.”
Kim Kardashian, 34, has over 42 million followers on Instagram and 25 million on Facebook.
The posts link to a company website that includes the FDA-approved labeling information.
Photo Instagram
However, FDA regulators say the posts violate rules for promoting drugs because they don’t mention side effects of Diclegis, which include sleepiness that can make it dangerous to drive or perform other activities that require mental alertness. The drug label warns that Diclegis should not be combined with alcohol or other medications that cause drowsiness, such as sleeping aids or certain pain relievers.
FDA regulations require manufacturers to balance benefit claims with information about drugs’ risks, even when space is limited.
The posts also fail to mention that Diclegis is not approved for women with a form of prolonged vomiting that causes dehydration, the FDA notes.
The FDA posted its warning letter online on August 11, addressed to the CEO of Canadian drugmaker Duchesnay Inc., which markets the drug. The letter notes that the privately held company received a similar warning in 2013 for omitting risk information from a letter to doctors.
FDA regulators are “concerned that Duchesnay is continuing to promote Diclegis in a violative manner,” states the letter dated August 7.
The agency calls on the company to remove the social media posts immediately and outline a plan for preventing future violations by August 21
The Quebec-based company said in a statement it “will take quick action in responding to the FDA’s letter and immediately and effectively address any issues”.
The FDA approved Diclegis in 2013 to treat vomiting and nausea in pregnant women who do not respond to more traditional measures. It is the only prescription drug approved in the US for morning sickness.
A different version of the drug was recalled by the agency in 1983 following a series of lawsuits alleging links to birth defects. However, FDA investigations never established any link between the drug and the reported problems.
Kim Kardashian’s posts cited by the FDA no longer appeared on her accounts on August 11.
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