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  • IV ondansetron may...

IV ondansetron may increase congenital malformations risk finds JAMA study  

Written By : Medha Baranwal |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2020-02-04T16:12:24+05:30  |  Updated On 4 Feb 2020 4:12 PM IST
IV ondansetron may increase congenital malformations risk finds JAMA study   
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Boston, Massachusetts: Intravenous administration of ondansetron may be associated with greater risks of congenital cardiac malformations and oral clefts, a recent study in the journal JAMA has suggested. The follow-up study refutes the findings of its previous study.

The study is a follow-up of a previous population-based cohort study that had evaluated the association between first-trimester exposure to the oral formulations of ondansetron and congenital malformations. It found that after accounting for potential confounding variables, there was no significant association with congenital malformations overall or cardiac malformations, but a small increased risk of oral clefts could not be excluded.

Ondansetron (Zofran) is commonly and increasingly prescribed to relieve nausea in pregnant women. In 2014, an estimated 22 percent of pregnant women in the U.S. had used the drug at some point during their pregnancy. Despite its prevalence, data on the safety of the drug and any effects on the developing fetus have been limited, with small-scale studies producing conflicting results.

Krista F. Huybrechts, Brigham and Women's Hospital, Boston, Massachusetts, and colleagues conducted a follow-up study to examine the association between intravenous ondansetron and congenital malformations.

The original retrospective cohort study was based on data from the nationwide Medicaid Analytic eXtract (MAX), a dataset that included more than 1.8 million pregnancies resulting in live births between 2000 and 2013 among publicly insured pregnant women. Records showed that patients had filled prescriptions for ondansetron in the first trimester of 88,467 (4.9 percent) pregnancies.

Potential explanations for the apparent difference in the teratogenic effect of intravenous compared with oral formulations include:

1. residual confounding by indication and associated factors (eg, nutritional deficiencies) in women with hyperemesis severe enough to require intravenous medication;

2. higher doses administered intravenously vs orally, and

3. higher specificity for exposure because studies of oral use in health care utilization data are based on dispensed medication and not all women may consume the medication as prescribed.

The study, "Intravenous Ondansetron in Pregnancy and Risk of Congenital Malformations," is published in the Journal of the American Medical Association.

DOI: 10.1001/jama.2019.18587

Source : JAMA
Medha Baranwal
Medha Baranwal

    MSc. Biotechnology

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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