Kim Kardashian has removed an Instagram post touting Diclegis after the Food and Drug Administration scolded her for failing to include the risk information about the prescription morning-sickness drug.
"OMG. Have you heard about this?" the social media celebrity posted about Diclegis along with an Instagram photo of the drug bottle. "As you guys know my #morningsickness has been pretty bad."
Kardashian went on to say studies have shown no increased risk to the baby, in her open promotion of Diclegis and manufacturer Duchesnay USA.
"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 www.diclegis.com; www.DiclegisImportantSafetyInfo.com."
Since Kardashian didn't add the required possible adverse effects of Diclegis, the federal agency faxed what amounted to a cease and desist letter to Duchesnay Executive Vice President Eric Gervais.
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The agency said it learned of the social media post through a complaint submitted to their Bad Ad program.
"Dear Mr. Gervais: The Office of Prescription Drug Promotion of the U.S. Food and Drug Administration has reviewed the Kim Kardashian Social Media Post for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) … 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."
A representative for Duchesnay USA told a published source it takes regulatory responsibilities very seriously and would be taking quick action to address the issue.
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The morning-sickness medication was withdrawn from the market 30 years ago under the name Bendectin but earned FDA approval in 2013 under new name Diclegis. Bendectin was prescribed after its introduction in 1956 until 1983 when it was pulled due to alleged safety issues.
Diclegis is the only medication specifically approved to treat upset stomach associated with morning sickness. In the decades between the drug's withdrawal from the market and its re-approval, the drug has undergone rigorous scrutiny and is now deemed safe by the FDA.
Another drug, Zofran, approved for nausea in cancer patients, is widely used for pregnancy.
Twitter: @SusanMorseHFN