• Lockwood G Taylor, Steven T Bird, Leyla Sahin, Melissa S Tassinari, Patty Greene, Marsha E Reichman, Susan E Andrade, Katherine Haffenreffer, and Sengwee Toh.
• Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
• Pharmacoepidemiol Drug Saf. 2017 May 1; 26 (5): 592-596.

PurposeTo examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births.MethodsWe assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation.ResultsIn over 2.3 million pregnancies, the prevalence of ondansetron, promethazine, metoclopramide, or doxylamine/pyridoxine use anytime in pregnancy was 15.2, 10.3, 4.0, and 0.4%, respectively. Ondansetron use increased from <1% of pregnancies in 2001 to 22.2% in 2014, with much of the increase attributable to oral ondansetron beginning in 2006. Promethazine and metoclopramide use increased modestly between 2001 (13.8%, 3.2%) and 2006 (16.0%, 6.0%) but decreased annually through 2014 (8.0%, 3.2%). Doxylamine/pyridoxine, approved for management of nausea and vomiting in pregnancy in 2013, was used in 1.8% of pregnancies in 2014. For all antiemetics, use was highest in the first trimester.ConclusionsWe observed a marked increase in ondansetron use by study year, prescribed to nearly one-quarter of insured pregnant women in 2014, occurring in conjunction with decreased use of promethazine and metoclopramide. Given the widespread use of ondansetron in pregnancy, data establishing product efficacy and methodologically rigorous evaluation of post-marketing safety are needed. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

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