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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.
On Aug. 7, 2015, FDA sent a
, the manufacturer of Diclegis (doxylamine succinate and pyridoxine hydrochloride), after Kim Kardashian endorsed the drug on various social media channels. Diclegis is indicated for morning sickness in pregnant women, and the celebrity, who is currently pregnant with her second child, posted a message on Instagram saying that the drug worked to help her nausea.
In the letter, FDA says that the post does not communicate the risks associated with the drug and is misleading because it paints the drug to be “safer than has been demonstrated.” The post did not mention that the drug is contraindicated for women with known hypersensitivity to any of the drug’s ingredients and for women currently prescribed monoamine oxidase inhibitors. It also did not mention that the drug has not been studied in women with hyperemesis gravidarum or that drowsiness is the most common adverse reaction associated with drug.
Here is Kardashian’s post, in full: “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. 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.”
The Office of Prescription Drug Promotion (OPDP) requested that Duchesnay “cease misbranding” of the drug immediately or pull the drug from the market. OPDP suggests the corrective communications be distributed using the same media used to deliver the initial messages (Instagram, Twitter, and Facebook) and include a description of the offense and new information to supplement the incomplete information contained in the original messages. It is unclear if Kardashian herself is expected to post the corrective communications, or if these messages will come from Duchesnay directly.
As of Aug. 11, 2015, Kardashian’s Instagram post had been taken down, but her verified Twitter page still referred to a partial version of the original Instagram message about Diclegis. Because Twitter has a character limitation, the corrective messages detailing the potential adverse effects of Diclegis would likely have to be distributed over a few posts, or contain a link to the full message on Instagram. FDA gave Duchesnay until Aug. 21, 2015 to comply with its request and present the agency with a detailed discontinuation plan.