On Sunday night, while the rest of the entertainment world was focused on the MTV Video Music Awards, Kim Kardashian West took to social media for another reason: to belatedly acknowledge the side effects of a controversial morning-sickness drug she endorses.
The posts on Facebook, Instagram, and Twitter carried the hashtag #CorrectiveAd. They followed an Aug. 7 warning from the U.S. Food and Drug Administration to drugmaker Duchesnay saying that Kardashian's original paid endorsement omitted important safety information.
#CorrectiveAd I guess you saw the attention my last #morningsickness post received. 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. For US Residents Only. Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments. Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum. Important Safety Information Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis. Additional safety information can be found at www.DiclegisImportantSafetyinfo.com or www.Diclegis.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
"I guess you saw the attention my last #morningsickness post received," Ms. Kardashian wrote as the VMAs, which she attended, were kicking off in Los Angeles. Her original post included links to websites with disclosures about the risks of the drug, Diclegis, which was approved in 2013 to treat morning sickness for women who don't respond to more conservative measures.
The rest of Ms. Kardashian's post was the kind of boilerplate risk information that voice actors speed through in the final seconds of TV drug ads: "Diclegis has not been studied in women with hyperemesis gravidarum," or extreme, persistent vomiting. She also included warnings about interactions with other medications and alcohol, as well as side effects like drowsiness.
Kardashian first praised the medication in July posts, broadcast to her millions of followers, that started with "OMG. Have you heard about this?" The posts have since been removed.
The FDA asked that the misleading drug messages be corrected in the format they were originally posted. Ms. Kardashian's timing on that request meant the posts were buried quickly: Her social media streams were soon overtaken by pictures of her at the VMAs with Kanye West, who, by the way, jokingly announced he planned to run for president.