Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE, Pediatrics / 19.12.2018
Does Zofran (ondansetron) for Nausea & Vomiting Cause Birth Defects?
MedicalResearch.com Interview with:
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Dr. Krista Huybrechts[/caption]
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.
Dr. Krista Huybrechts[/caption]
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.
Dr. Barrett[/caption]
Charles Barrett. Ph.D.
School Psychologist
Loudon County Virginia
Public Schools
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Numerous studies have shown that Black children are more likely to receive ratings that are more indicative of displaying externalizing behavior difficulties, including Attention Deficit Hyperactivity Disorder (ADHD). However, many of these studies included teachers as the informants. Consistent with most teachers in the United States, raters have typically been White females. For this reason, it is unclear if these outcomes would exist if the rater and child shared the same racial/ethnic background. Additionally, most research in the United States that involved cross-cultural comparisons has used White and Hispanic boys. Few empirical studies have examined differences between Black and White boys.
The present study sought to address several limitations in the field. Most notably, cross-cultural comparisons between Black and White boys were included instead of Hispanic and White children. Next, maternal figures, rather than teachers, were included as the informants.
The present study was developed using a similar methodology that examined Hispanic and White boys’ behavior from the perspective of Hispanic and White teachers (Dominguez de Ramirez & Shapiro, 2005). In sum, we sought to determine if there were differences in how Black and White maternal figures rated Black and White boys who were demonstrating the same level/type of behavior (i.e., sub-clinical levels of
Eliane Abou-Jaoude, MD
Allergy and Immunology Fellow
Henry Ford Health System
Detroit, Michigan
MedicalResearch.com: What is the background for this study?
Response: Early life exposure to diverse types of microbes is necessary for healthy immune development and may impact the risk for developing allergic disorders.
Theoretically the transfer of parental microbes to their offspring during infancy can influence a child’s developing gut microbiome and subsequent immune response patterns.
We wished to investigate whether parental pacifier cleaning methods, reported at 6-months of age, were associated with altered serum IgE trajectory over the first 18 months of life.
Dr. Quast[/caption]
Troy Quast, PhD
Associate Professor in the University
South Florida College of Public Healt
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: One of the cited repercussions of the opioid epidemic is its effect on families. However, there is considerable variation in opioid misuse across the county. This is the first nation-wide study to investigate the relationship between opioid prescription rates and child removals at the state level.
I found that there are significant differences across states in the relationship between opioid prescription and child removal rates associated with parental substance abuse. In twenty-three states, increases in opioid prescription rates were associated with increases in the child removal rate. For instance, in California a 10% increase in the county average prescription rate was associated with a 28% increase in the child removal rate. By contrast, in fifteen states the association was flipped, where increases in the opioid prescription rate were associated with decreases in the child removal rate. There was no statistically significant relationship in the remaining states.