What happened between Mrs. Kardashian West and the FDA in 2015 is very interesting to all of us. She praised and suggested a prescribed drug against morning sickness. The FDA claimed it was a commercial and sent a warning letter to the company, which produced the drug. Kim Kardashian West changed her post and admitted it was a commercial. Was it true? Mrs. Kardashian West just expressed her personal opinion and wanted to share with her followers a piece of advice. She share her personal story, like many other Internet users, and her patient experience should have been respected. Her story shows what patient empowerment is and how the Net is a precious resource for patients to share their stories that might help other patients. For this reason, doctors should not be afraid of the Net and its potentiality.
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It is morning. You wake up; your head swirls and pounds heavily, and you can barely breathe. You are about to throw up. Luckily, your doctor prescribed you yesterday a powerful medication to prevent this bothersome nausea. You are so glad that you have finally found this drug that you want to share it with the entire world. You write on your webpage on a social media an enthusiastic post about the miraculous effect of this pill. No morning sickness anymore! This problem, according to your point of view, has not received the attention it deserves:
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.DiclegisImportantSafetyInfo.com.
A couple of days later, you radically change the text and post the following:
#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.fda.gov/medwatch or call 1-800-FDA-1088.