Does the morning sickness pill even work? Researchers are taking a second look at the prescription medicine

P. Claire Dodson
Updated


Photo: Getty Images

If you’re pregnant or thinking about becoming pregnant, maybe think twice about reaching for a morning sickness pill. Not necessarily because it’s unsafe, but because it may not even really work. Because let’s be real — nothing can really get rid of morning sickness.

Dr. Navindra Persaud, a doctor in the family and community medicine department in Toronto’s St. Michael’s Hospital, recently published a paper in the journal PLOS ONE that calls into question the validity of an unpublished study the FDA has used as supporting evidence for the efficacy of a morning sickness pill called Diclegis in the United States.

If that drug sounds familiar, it’s probably because of Kim Kardashian. Kardashian was paid by Duchesnay to promote Diclegis on Instagram, which she did — without adequately mentioning risks or limitations. The FDA got involved and Kardashian posted a revised caption.

#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 Aug 30, 2015 at 6:01pm PDT

“We are trying to provide patients and doctors with access to complete and accurate information so that they can make informed decisions,” Persaud told NPR’s Shots in an email. “This information may lead regulators like the FDA and Health Canada to revisit previous decisions.”

The drug is a combination of an over-the-counter antihistamine and vitamin B6, and the study in question was never put through an extensive peer review process because it was never published, though that didn’t stop the FDA from including its findings as supporting evidence.

Richard Harris of NPR writes that the reviewers at the FDA didn’t even find the drug that effective.

Using a 15-point measure of nausea and vomiting called the PUQE score (who says scientists are humorless!) women taking Diclectin reported a 4.7 point improvement, versus a 3.9 point improvement for women taking placebo. So the drug was only marginally better than a placebo, but that was good enough for FDA approval.

But the FDA is in the process of reviewing Persaud’s PLOS ONE paper.

The American Congress of Obstetricians and Gynecologists does recommend that before taking medicine for morning sickness, those that are pregnant first try more traditional methods of getting over nausea, like drinking water and eating dry toast and crackers.

Even though Diclegis might not do any real harm, it also might not do much good. And it brings up a necessary conversation about how the FDA approves drugs that become part of our everyday life, and how we can protect ourselves going forward. But if your morning sickness is getting in the way of your life, the first thing to do is talk to your doctor.