Kim Kardashian West's Diclegis #CorrectiveAd clears air on FDA requirements

Be the first to comment

The reality-show star took to Instagram again on Sunday night to promote morning sickness medication Diclegis, this time with extensive risk information

Celebrity Kim Kardashian West posted what she called a #CorrectiveAd on Sunday night, adding extensive risk information to a deleted post she made on behalf of morning sickness pill Diclegis earlier this month.

The Food and Drug Administration said an earlier post, featuring the same image as Sunday’s, was "false and misleading" because it failed to include any information about the drug’s potential risks. The federal agency sent a warning letter to drug maker Duchesnay USA, which markets Diclegis, on August 7.  

Sunday’s post, which went online during MTV’s Video Music Awards, contained a lengthy disclaimer about potential side effects.

"I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay Inc. that my last post about Diclegis was incomplete because it did not include any risk information or important limitations of use for Diclegis," Kardashian said in the more recent Instagram post. "A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m reposting and sharing this important information about Diclegis."

#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.

A photo posted by Kim Kardashian West (@kimkardashian) on

This article first appeared on prweek.com.