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August 14, 2015

Kim Kardashian, morning sickness and FDA outrage

by: Kimberly Barone Baden

Kim Kardashian West’s endorsement of the morning sickness drug Diclegis® made some serious waves in the social media world, and not just with her 40 million-plus Instagram followers or expectant mothers.

When the FDA found out about her Instagram endorsement for Diclegis that stated, among other things, that “it’s been studied and there was no increased risk to the baby,” they quickly sent a warning letter to drug manufacturer Duchesnay, Inc. The warning included a demand that “truthful, non-misleading and complete corrective messages” should be sent out about the drug “using the same media” used to promote it or, in the alternative, that they should cease distribution of Diclegis.

As an attorney that has litigated birth defect and morning sickness drug-related cases in the past, this story naturally caught my eye—not to mention that of the media and consumers.

Why you can’t just say a drug is safe on social media

As a prescription drug, Diclegis is one of the older drugs on the market. Although it was only recently approved under the name Diclegis, it was originally marketed in the 1950s as a morning sickness drug under the name Bendectin®.

Diclegis is basically a combination of vitamin B6 (pyridoxine hydrochloride) and an antihistamine (doxylamine succinate) that you can find in over-the-counter drugs such as Unisom. Certain antihistamines help to reduce the vomiting reflex, and a slight increase in vitamin B6 has been linked to nausea reduction in some pregnant women.

But Kim Kardashian’s testimonial didn’t tell the whole story, and that’s what has the FDA up in arms.

As with any form of drug advertising, which Kardashian’s post was according to the FDA, the potential side effects always need to be listed, and simply linking to the manufacturer’s website doesn’t cut it.

Despite the fact that observational studies “have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus,” what Kardashian failed to state is that Diclegis is contraindicated in people who:

  • Have a known hypersensitivity to doxylamine succinate and other ethanolamine derivative antihistamines
  • Have a known hypersensitivity to pyridoxine hydrochloride
  • Are taking monoamine oxidase inhibitors (MAOIs)

Additionally, the drug has not been studied in hyperemesis gravidarum, one of the most severe forms of morning sickness.

While Kardashian’s intent was to share her own positive experiences with this morning sickness medication, her social media post entirely omitted all risk information.

Always research a prescription drug before taking it

The risks of taking any drug, especially during pregnancy, should be carefully considered before use as some drugs may carry additional risks that your healthcare provider may not immediately be aware of.

Take Zofran®, for example.

Although Zofran is approved to treat nausea and vomiting in patients following chemotherapy treatments or surgery, it has been prescribed off-label to expectant mothers suffering from morning sickness. What some studies have found, however, is that the use of Zofran during pregnancy, particularly during the first trimester, may be associated with potential birth defects such as heart defects and oral clefts, including cleft palate.

Another drug, Zoloft®, which is used to treat major depression and other psychiatric disorders, may also be associated with an increased risk of birth defects.

Feel confident in raising any potential concerns or questions

Regardless of anyone’s recommendations, celebrity or otherwise, you should always be proactive about you and your baby’s health and do a little bit of digging before taking a prescription drug during pregnancy. Even if it turns out to be safe, you will feel better taking it after knowing that you did everything you could to ensure a happy and healthy pregnancy.