title: Treating morning sickness in the United States--changes in prescribing are needed.
abstract: Presently, 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration. The use of ondansetron for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias. In April 2013, the Food and Drug Administration approved the combination of doxylamine and pyridoxine, specifically for nausea and vomiting in pregnancy symptoms. Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.
authors.affiliation: The Motherisk Program, The Hospital for Sick Children and University of Toronto, Toronto, ON.
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
mesh_terms: D000932:Antiemetics / Q000627:therapeutic use*; D004025:Dicyclomine / Q000627:therapeutic use*; D004319:Doxylamine / Q000627:therapeutic use*; D017277:Drug Approval; D004338:Drug Combinations; D005260:Female; D006330:Heart Defects, Congenital / Q000139:chemically induced; D006801:Humans; D048968:Morning Sickness / Q000188:drug therapy*; D017294:Ondansetron / Q000009:adverse effects*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011247:Pregnancy; D011736:Pyridoxine / Q000627:therapeutic use*; D020230:Serotonin Syndrome / Q000139:chemically induced; D016171:Torsades de Pointes / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000932:Antiemetics; D004338:Drug Combinations; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D017294:Ondansetron; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine
keywords: nausea and vomiting; ondansetron; pregnancy