As we noted a few weeks ago, Duchesnay, the company that manufactures prescription morning sickness medication Diclegis, received a warning letter from FDA after Kim Kardashian posted a "selfie" on Instagram and Twitter, holding a bottle of the medication. The warning letter was issued because FDA said the social media post presented efficacy claims for Diclegis, but failed to communicate any of the risks associated with the use of the medication.
On Sunday, Kim posted the same selfie yet again. The difference this time? The accompanying caption. The caption that went along with the post is as follows:
“#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.”
Although the correction came almost a month after FDA contacted Duchesnay about the post, there is no doubt that Duchesnay has achieved the goal of the Kim Kardashian social media posts. Since Kim Kardashian’s initial post on July 19, 2015, conversations about the drug on social media have spiked dramatically, posing questions about whether this will become a trend across the industry.
We know how challenging it can be to stay on top of all of FDA’s rules and regulations regarding the advertisement of your products; which is why we are here to help. We have helped a number of companies comply with ad rules and ensure that they are only promoting their products in ways FDA will accept. To find out how we can help you comply with FDA’s rules and regulations, please contact us.
