Kim Kardashian-West took to Instagram on Sunday to promote a medication called Diclegis, a prescription drug that helps treat nausea during pregnancy. The reality star is known for lending her name to plenty of wacky products. Is this one of them?
Update (September 1, 2015): Kim Kardashian West has issued a new-and-improved Instagram for her morning sickness drug endorsement after the original photo caption drew heat from the U.S. Food and Drug Administration (FDA) for failing to include key safety facts.
On Monday, the Keeping Up with the Kardashians star, 34, posted a photo of herself holding a bottle of the prescription drug Diclegis, alongside an updated caption that now includes the medicine's side effect information and the limitations of its use. The move comes three weeks after the FDA issued a warning letter to the CEO of the Canadian pharmaceutical company for the TV personality's sneaky post.
"I guess you saw the attention my last #morningsickness post received," Kardashian West kicked off the new post. "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 didnât meet FDA requirements. So, Iâm re-posting and sharing this important information about Diclegis."
The FDA originally issued the letter Aug. 7, requiring Duchesnay USA Inc. to remove Kardashianâs "false or misleading" social media message immediately and to provide a written response detailing how they plan to avoid any other violations in the future. And per the reality star's revised message, the company appears to have obeyed the FDA's terms.
#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.
The 34-year-old reality star took to Instagram on Sunday to promote Diclegis, a prescription medication that helps treat nausea during pregnancyÂ if diet and lifestyle changes are still leaving you up close and personal with the toilet. (Representatives for the drug's maker confirmed to Health that she's being paid to promote it on social media.)
"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, itâs been studied and there was no increased risk to the baby,"Â the famous mommy captioned a snapshot of herself holding up the bottle.
So what exactly is this Kardashian-approved Rx? It's a delayed-release drugÂ made up of a combination of two substances, the antihistamineÂ doxylamine and vitamin B6. But in case you've already hunted around the Internet to get the lowdown on the medication, you may have discovered that it temporarily got a bad rep back in the '80s.
"[The medicine] used to be sold in the U.S. under the name of Bendectin," explains Jan Rydfors, MD, a California-based board certified ob/gyn and co-creator of the popular app Pregnancy Companion MD. "Bendectin was taken off the market in 1983 due to unsubstantiated lawsuits which made it too expensive for the manufacturer to keep on selling it. It continued to, however, be sold successfully around the world."
After more recent studies proved the medicine was safe and did not cause any birth defects or harm to the baby, it was reintroduced to the U.S. market under its new name, Diclegis, in 2013. Now, the little white tablet, identifiable by the purple image of a pregnant woman on the pill, not only has Kim's stamp of approval, but also the FDA. The government agency considers it a "pregnancy category A" drug, meaning there's good evidence it won't harm you or the baby.
Now, that doesn't mean you should take medical advice from Mrs. Kardashian-West. (Though we'll give her credit: she's at least promoting something with research behind it this time.) Instead, here are the facts, straight from the experts.
Who should be prescribed Diclegis?
"Any woman who has significant nausea and vomiting to the point where it affects her quality of life is a candidate for it," Dr. Rydfors adds. "It is a very safe drug, and many women wait too long to start it due to unsubstantiated safety concerns regarding their baby."
What are the risks?
Drowsiness is the main side effect, explains Joshua U. Klein, MD, assistant clinical professor of obstetrics, gynecology and reproductive science at the Icahn School of Medicine at Mount Sinai in New York City. "If a woman's job or lifestyle requires her to be on constant alert, this may not be suitable," he says. It has similar effects as other antihistamines (Benadryl or Dramamine, for example).
Diclegis is not recommendedÂ for women with severe asthma or those also taking antidepressants. Also: If you've been told during an eye exam that you have high eye pressure or narrow-angle glaucoma, your doctor may think it's too risky for you.
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What are the best natural remedies for morning sickness?
Before heading straight to your doctor for an Rx, firstÂ try to eat small meals consisting of crackers, bread, and other bland foods when nausea kicks in. Coconut juice, chicken soup, sports drinks, and ginger ale can also be helpful. And stock up on candy to carry with you, for those times when it happens randomly; sucking on a sweet can help: "There are ginger lollipops that are becoming increasingly popular," Dr. Klein says.
Also worth a try in the moment: "[Press and hold for a few breaths] on an acupuncture point on the wrist near the palm," Dr. Rydfors says.
Now, how do we feel about big celebrity endorsements?
"Celebrities have potential to do a lot of good with their status, and can also do harm," Dr. Klein says. "The main potential for good in this case is that if there is a woman who is suffering from nausea and her doctor hasnât brought up the option of a safe medication, she can then raise the conversation after coming across the endorsement online. And with someone as big as Kim Kardashian, itâs inevitable that the word will spread in a powerful way."
But keep in mind, each patient is going to have different biological conditions that determine how medication works in the body. "Not everyone is Kim Kardashian," Dr. Klein says.
"A celebrity who takes a stand in a major way against proven, researched science is obviously very problematic," Dr. Klein says. "Itâs a potentially harmful thing to do. But I think it's much more okay for a celebrity to say, like in this case, 'Iâm pregnant, this is safe, it works for me, but always talk to your medical provider.' "