This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5404. E-mail: [email protected].
Use of the anti-nausea medication metoclopramide (Reglan) in pregnancy is not associated with an increased risk of major congenital malformations, spontaneous abortion, or stillbirth. These were the findings of large, register-based cohort study from Denmark. The safety of metoclopramide in pregnancy has been of concern because it is increasingly used to treat pregnant women with nausea and vomiting. Metoclopramide-exposed pregnant women were matched with unexposed women in a 1:4 ratio, with more than 40,000 exposed women in the cohort, of whom more than 28,000 received the drug in the first trimester. The drug was not associated with major malformations or any of more than 20 individual malformations. There was no increase in spontaneous abortion, stillbirth, preterm birth, low birth weight, or fetal growth restriction (JAMA 2013; 310:1601-1611).
Evidence-based updates in clinical pharmacology .
In this issue: Reglan safe in pregnancy; battle brewing over naming of biosimilar drugs; and FDA actions.
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