Actualización en riesgo materno. ¿Es el ondansetron seguro durante el embarazo?
Motherisk update. Is ondansetron safe for use during pregnancy?
Koren G.
Can Fam Physician. 2012 Oct;58(10):1092-3.
Abstract
QUESTION: While I usually prescribe doxylamine-pyridoxine for morning sickness, some of my patients with severe nausea and vomiting of pregnancy (NVP) receive ondansetron in hospital. I have read some new precautions recommended by the US Food and Drug Administration (FDA). Is ondansetron safe to use during pregnancy?
ANSWER: During the past decade ondansetron has been increasingly used in the United States for NVP, owing to the lack of an FDA-approved drug for this condition. While fetal safety data for doxylamine-pyridoxine are based on more than a quarter of a million pregnancies, the fetal safety data for ondansetron are based on fewer than 200 births. Moreover, a recent case-control study suggested there was an increased risk of cleft palate associated with ondansetron. Recently, the FDA issued a warning about potentially serious QT prolongation and torsade de pointes associated withondansetron use; the warning included a list of precautions and tests that must be followed. The drug is not labeled for use in NVP in either the United States or Canada. Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy.
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Uso "fuera de etiqueta" de ondansetron en el embarazo, en Australia Occidental
Off-label use of ondansetron in pregnancy in Western Australia.
Colvin L, Gill AW, Slack-Smith L, Stanley FJ, Bower C.
Biomed Res Int. 2013;2013:909860. doi: 10.1155/2013/909860. Epub 2013 Dec 12.
Abstract
AIMS: Nausea and vomiting of pregnancy is the most common medical condition in pregnancy. There is an increasing trend to prescribeondansetron although its safety for use in pregnancy has not been established. METHODS: Exposed pregnancies were all births in Western Australia, 2002-2005, where the mother was dispensed ondansetron under the Australian Pharmaceutical Benefits Scheme, compared with all other births during the same period. Outcomes investigated include maternal and child characteristics, birth defects, pregnancy, and delivery characteristics.
RESULTS: There were 96,968 births from 2002 to 2005. Ondansetron was dispensed to 251 pregnant women during this period. The women dispensed ondansetron were more likely to be privately insured (OR: 5.8; 95% CI: 4.3-7.9), to be Caucasian (3.3; 1.9-5.7), not to smoke during their pregnancy (2.9; 1.8-4.7), to have a multiple birth (2.7; 1.5-5.0), and to have used fertility treatment (1.8; 1.0-3.4). There was a small but not significantly increased risk of a major birth defect with first trimester exposure (1.2; 0.6-2.2). CONCLUSIONS:Our study did not detect any adverse outcomes from the use of ondansetron in pregnancy but could not conclude that ondansetronis safe to use in pregnancy.
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Ondansetron en el embarazo y riesgo de resultados adversos
Ondansetron in pregnancy and risk of adverse fetal outcomes.
Pasternak B, Svanström H, Hviid A.
N Engl J Med. 2013 Feb 28;368(9):814-23. doi: 10.1056/NEJMoa1211035.
Abstract
BACKGROUND: Ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well studied. METHODS:
We investigated the risk of adverse fetal outcomes associated with ondansetron administered during pregnancy. From a historical cohort of 608,385 pregnancies in Denmark, women who were exposed to ondansetron and those who were not exposed were included, in a 1:4 ratio, in propensity-score-matched analyses of spontaneous abortion (1849 exposed women vs. 7396 unexposed women), stillbirth (1915 vs. 7660), any major birth defect (1233 vs. 4932), preterm delivery (1792 vs. 7168), and birth of infants at low birth weight and small for gestational age (1784 vs. 7136). In addition, estimates were adjusted for hospitalization for nausea and vomiting during pregnancy (as a proxy for severity) and the use of other antiemetics. RESULTS: Receipt of ondansetron was not associated with a significantly increased risk of spontaneous abortion, which occurred in 1.1% of exposed women and 3.7% of unexposed women during gestational weeks 7 to 12 (hazard ratio, 0.49; 95% confidence interval [CI], 0.27 to 0.91) and in 1.0% and 2.1%, respectively, during weeks 13 to 22 (hazard ratio, 0.60; 95% CI, 0.29 to 1.21). Ondansetron also conferred no significantly increased risk of stillbirth (0.3% for exposed women and 0.4% for unexposed women; hazard ratio, 0.42; 95% CI, 0.10 to 1.73), any major birthdefect (2.9% and 2.9%, respectively; prevalence odds ratio, 1.12; 95% CI, 0.69 to 1.82), preterm delivery (6.2% and 5.2%; prevalence odds ratio, 0.90; 95% CI, 0.66 to 1.25), delivery of a low-birth-weight infant (4.1% and 3.7%; prevalence odds ratio, 0.76; 95% CI, 0.51 to 1.13), or delivery of a small-for-gestational-age infant (10.4% and 9.2%; prevalence odds ratio, 1.13; 95% CI, 0.89 to 1.44). CONCLUSIONS: Ondansetron taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. (Funded by the Danish Medical Research Council.).
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Medicamentos para nausea y vomito en el embarazo y el riesgo de defectos de nacimiento seleccionados.
Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects.
Anderka M1, Mitchell AA, Louik C, Werler MM, Hernández-Diaz S, Rasmussen SA; National Birth Defects Prevention Study. Birth Defects Res A Clin Mol Teratol. 2012 Jan;94(1):22-30. doi: 10.1002/bdra.22865. Epub 2011 Nov 19.
Abstract
BACKGROUND: Nausea and vomiting of pregnancy (NVP) occurs in up to 80% of pregnant women, but its association with birth outcomes is not clear. Several medications are used for the treatment of NVP; however, data are limited on their possible associations with birth defects. METHODS: Using data from the National Birth Defects Prevention Study (NBDPS)-a multi-site, population-based, case-control study-we examined whether NVP or its treatment was associated with the most common noncardiac defects in the NBDPS (nonsyndromic cleft lip with or without cleft palate [CL/P], cleft palate alone [CP], neural tube defects, and hypospadias) compared with randomly selected nonmalformed live births. RESULTS: Among the 4524 cases and 5859 controls included in this study, 67.1% reported first-trimester NVP, and 15.4% of them reported using at least one agent for NVP. Nausea and vomiting of pregnancy was not associated with CP or neural tube defects, but modest risk reductions were observed for CL/P (adjusted odds ratio [aOR] = 0.87; 95% confidence interval [CI], 0.77-0.98) and hypospadias (aOR = 0.84; 95% CI, 0.72-0.98). Regarding treatments for NVP in the first trimester, the following adjusted associations were observed with an increased risk: proton pump inhibitors and hypospadias (aOR = 4.36; 95% CI, 1.21-15.81), steroids and hypospadias (aOR = 2.87; 95% CI, 1.03-7.97), and ondansetron and CP (aOR = 2.37; 95% CI, 1.18-4.76), whereas antacids were associated with a reduced risk for CL/P (aOR = 0.58; 95% CI, 0.38-0.89). CONCLUSIONS: NVP was not observed to be associated with an increased risk of birth defects; however, possible risks related to three treatments (i.e., proton pump inhibitors, steroids and ondansetron), which could be chance findings, warrant further investigation.
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Tratamiento de las náuseas del embarazo en los Estados Unidos. Se necesitan cambios en la prescripción
Treating morning sickness in the United States--changes in prescribing are needed.
Koren G.
Am J Obstet Gynecol. 2014 Dec;211(6):602-6. doi: 10.1016/j.ajog.2014.08.017. Epub 2014 Aug 20.
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 fetalsafety.
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Nausea y vomito en el embarazo temprano
Nausea and vomiting in early pregnancy.
Festin M.
BMJ Clin Evid. 2009 Jun 3;2009. pii: 1405.
Abstract
INTRODUCTION: More than half of pregnant women suffer from nausea and vomiting, which typically begins by the 4th week and disappears by the 16th week of pregnancy. The cause of nausea and vomiting in pregnancy is unknown, but may be due to the rise in human chorionic gonadotrophin concentration. In 1 in 200 women, the condition progresses to hyperemesis gravidarum, which is characterised by prolonged and severe nausea and vomiting, dehydration, and weight loss. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatment for nausea and vomiting in early pregnancy? What are the effects of treatments for hyperemesis gravidarum? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 30 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupressure; acupuncture; antihistamines; corticosteroids; corticotrophins; diazepam; dietary interventions other than ginger; domperidone; ginger; metoclopramide; ondansetron; phenothiazines; and pyridoxine (vitamin B6).
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