Does Zofran (ondansetron) for Nausea & Vomiting Cause Birth Defects?

MedicalResearch.com Interview with:

Krista F. Huybrechts, M.S., Ph.D. Assistant Professor of Medicine at Harvard Medical School Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital. Boston, MA 02120

Dr. Krista Huybrechts

Krista F. Huybrechts, MS PhD
Associate Professor of Medicine
Brigham and Women’s Hospital
Harvard Medical School
Boston, MA 02120 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Pregnant women often experience nausea and vomiting, particularly during the first trimester.  Early treatment is recommended to relieve symptoms and prevent progression to hyperemesis gravidarum.  Although not formally approved for this indication, ondansetron is the most frequently prescribed treatment for nausea and vomiting in pregnancy in the US: 22% of pregnant women reportedly used ondansetron in the US in 2014. Despite this common use, the available evidence on the fetal safety of ondansetron is limited and conflicting, and the possibility of a doubling in risk of cleft palate and cardiac malformations has been raised.

We therefore evaluated the association between ondansetron exposure during the first trimester of pregnancy, the period of organogenesis, and the risk of congenital malformations in a cohort of 1,816,414,publicly insured pregnancies using the nationwide Medicaid Analytic eXtract data for 2000-2013.  A total of 88,467 women (4.9%) were exposed to ondansetron during the first trimester.  After adjusting for a broad range of potential confounding variables, we found no association with cardiac malformations (RR = 0.99; 95% CI, 0.93 – 1.06)  and congenital malformations overall (RR = 1.01; 95% CI, 0.98 – 1.05). For oral clefts, we found a 24% increase in risk (RR=1.24; 95% CI, 1.03 – 1.48), which corresponds to an absolute risk of 2.7 per 10,000 births (95% CI, 0.2 – 5.2 per 10,000 births).  These findings were consistent across sensitivity analyses, conducted to address potential misclassification and confounding bias. 

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Two Genes Linked to Severe Nausea and Vomiting in Pregnancy

MedicalResearch.com Interview with:

Marlena Fejzo, PhD Aassociate researche David Geffen School of Medicine UCLA.

Dr. Fejzo

Marlena Fejzo, PhD
Aassociate researche
David Geffen School of Medicine
UCLA. 

MedicalResearch.com: What is the background for this study?

Response: Most women experience some nausea and vomiting of pregnancy, and the worst 2% are diagnosed with Hyperemesis Gravidarum which is associated with poor maternal and fetal outcomes. I had HG in 2 pregnancies. In my second pregnancy my HG was so severe that I could not move without vomiting and did not keep any food or water down for 10 weeks. I was put on a feeding tube, but ultimately lost the baby in the second trimester. I am a medical scientist by training so I looked into what was known about HG. At the time, very little was known, so I decided to study it. I partnered with the Hyperemesis Education and Research Foundation (HER) and we did a survey on family history of .Hyperemesis Gravidarum that provided evidence to support a role for genes. I collected saliva samples from HG patients and their unaffected acquaintances to do a DNA study. Then I partnered with the personal genetics company, 23andMe to do a genome scan and validation study, which identified 2 genes, GDF15 and IGFBP7, linked to HG.

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Nausea and Vomiting During Pregnancy May Signal Less Risk of Pregnancy Loss

MedicalResearch.com Interview with:
Stefanie N. Hinkle, Ph.D.

Staff Scientist | Epidemiology Branch
Division of Intramural Population Health Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Thank you for the interest in our research. Nausea and vomiting are very common early in pregnancy and these symptoms can be difficult for women. Before we began this study there was very limited high-quality data on the implications of these difficult symptoms in pregnancy. Our study is unique because we asked women to report their symptoms continuously throughout their pregnancy before they may or may not have gone on to have a loss. We found that among women with 1 or 2 prior pregnancy losses, women who have nausea, and particularly nausea with vomiting, were less likely to have a pregnancy loss.

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