Kim Kardashian Reposts Morning Sickness Pills With Full Warning Label
During the VMAS, Kim Kardashian posted on Instagram a selfie advertising morning sickness pills that the FDA had earlier pressured her to remove, but this time with the drug's side effects.
Kim Kardashian reposted a selfie during the MTV's Video Music Awards that she had earlier been asked to remove because it advertised morning sickness pills without noting their possible side effects, but this time there was long a list of warnings.
The U.S. Food and Drug Administration sent a warning letter earlier in the month to the pharmaceutical company Duchesnay to remove a selfie posted by Kim Kardashian advertising Diclegis that didn't include the drug's possible side effects.
The reality star reposted the ad on Instagram on Sunday, saying "I guess you saw the attention my last #morningsickness post received."
Duchesnay got a warning letter from the FDA in mid-August after it paid Kardashian to post the selfie with its morning sickness pills. The post had included a link the the company's website, which goes to a page that does have the possible side effects.
"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," the FDA warning letter to Duchesnay said.
The FDA said that the Instagram post was also in violation because it did not warn that the drug hadn't been tested on women with severe morning sickness, called hyperemesis gravidarum.
A spokesperson for Duchesnay USA told BuzzFeed News that Kardashian had shared her personal experience with the company, which then wrote the Instagram post that she shared to her social media followers.
The new caption reads:
#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.