In a pharmacokinetic study of 16 epileptic patients maintained. New zealand datasheet 1 product name ondansetrondrla tablets. Most pregnant women experience some form of nausea and vomiting, and prevalence rates are as high as 50% to 80%. The management of nausea and vomiting of pregnancy and. How safe and effective is ondansetron for nausea and.
Pregnancy outcome following in utero exposure to ondansetron. The data source, study design, and analytic methods were the same as described in our previously published evaluation of oral ondansetron. The safety of ondansetron for nausea and vomiting of pregnancy. Antiemetic efficacy of ondansetron versus metoclopramide the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Therefore we conducted a nationwide cohort study testing if use of ondansetron during the first trimester was associated with different subgroupings off malformations. Listing a study does not mean it has been evaluated by the u. While some studies suggested no increase in birth defects in women who took ondansetron early in pregnancy, others suggested the.
Ondansetron is a medication used to treat nausea and vomiting that may be caused by surgery, chemotherapy or radiation therapy. Ondansetron in pregnancy and the risk of congenital malformations. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo, or foetus, the course of gestation and peri and. However, on the basis of available data, no dosage adjustment for ondansetron is recommended see. Taking ondansetron during pregnancy does not appear to. Offlabel use of ondansetron in pregnancy in western australia. Hg is the severe form of nvp, which affects about 0. Ondansetron is commonly prescribed for nausea during early pregnancy. Ondansetron for treatment of nausea and vomiting of pregnancy.
Ondansetron in pregnancy and risk of adverse fetal. Cc0 public domain ondansetron zofran is commonly and. Antiemetic efficacy of ondansetron versus metoclopramide. A cohort study showed no significant differences in pregnancy and fetal outcomes between 176 women who were exposed to ondansetron and 352 who were not exposed. Moreover, a recent casecontrol study suggested there was an increased risk of cleft palate associated with ondansetron. Two epidemiologic studies have suggested that ondansetron may increase the risk of birth defects 10, 11. Both pregnancies were analyzed separately for the purposes of this study. The overall prevalences of ondansetron use among participants in the control group with firsttrimester nausea and vomiting of pregnancy were 3.
Importantly, a recent large control study by the slone epidemiology center in boston, mass, and the centers for disease control and prevention in atlanta, ga, detected a 2fold increased risk of cleft palate associated with ondansetron taken for nvp in the first trimester. Mostly, the patients in the study were able to use less zofran gradually. A third study found no association overall 12 but lacked power to examine individual birth defects. The study included all women giving birth in denmark 1997 and 2010.
This is a descriptive retrospective case series of 14 pregnant women treated with ondansetron for hyperemesis gravidarum hg at chu saintejustine, from january 2002 to october 2011. Nausea and vomiting during pregnancy sometimes termed morning sickness are among the most common medical issue to arise during pregnancy. This drug should be used during pregnancy only if clearly needed us au tga pregnancy category. Animal studies have failed to reveal evidence of harm to the embryo, fetus, gestation period, perinatalpostnatal. Symptoms can be more severe in women carrying twins. At higher doses, there have been reports that ondansetron use might cause a heart rhythm problem called qt interval prolongation in the person taking ondansetron. Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment ondansetron may be used for purposes not listed in this medication guide. We evaluated the pharmacokinetics of ondansetron at three different gestational time points in a 26. If use is absolutely necessary, caution should be exercised, especially during the first trimester. It is not known whether ondansetron passes into breast milk or if it could harm a nursing baby. Oct 24, 2019 ondansetron is not expected to harm an unborn baby. Association of maternal firsttrimester ondansetron use with. The safety of ondansetron for nausea and vomiting of. Study examines effects of taking ondansetron during first.
They felt better within a period of three to five days after chemotherapy, as compared to taking zofran alone. The findings of these studies have been questioned, and the role of ondansetron in. Two of the patients received ondansetron during two separate pregnancies. Only limited data concerning the safety of ondansetron in pregnancy is available. Inhaled isopropyl alcohol superior to oral ondansetron as an. Moreover, the lack of other, similar cohort studies precluded conducting a meta analysis to increase the sample size. Ondansetron is a selective 5ht 3 serotonin antagonist used in the treatment of chemotherapyinduced and postoperative nausea and vomiting, and offlicence for nausea and vomiting in pregnancy nvp and hyperemesis gravidarum hg. More evidence that ondansetron is safe during pregnancy. Find out what health conditions may be a health risk when taken with ondansetron hcl oral.
Women who have previously suffered from nausea and vomiting in pregnancy are more likely to have symptoms in a subsequent pregnancy. Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip andor cleft palate. The earliest study evaluating the safety of ondansetron in pregnancy was conducted by einarson et al. The study included all women giving birth in denmark between 1997. How safe and effective is ondansetron for nausea and vomiting. In 1997, ondansetron was the subject of a metaanalysis case study published in the british medical journal. Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting. A 20 retrospective cohort study looked at 608,385 pregnancies among women in denmark, of whom 1970 0. The same authors repeated the analysis for intravenous exposures and found that intravenously administered ondansetron was not associated with an increase in the risk of cardiac malformations. Ondansetron for treatment of nausea and vomiting of. Use of ondansetron during pregnancy and congenital malformations.
Ondansetron is not approved for use by anyone younger than 4 years old. The nonpsychoactive cannabinoid cbd interacts with serotonin release receptors and has been shown to help alleviate nausea and vomiting. Therefore we conducted a nationwide cohort study testing the hypothesis use of ondansetron during the first trimester was associated with a higher prevalence of congenital malformations. Mar 09, 2018 mean nausea scores decreased by 30 mm in the alcohol ondansetron group, 32 mm in the alcoholplacebo group, and 9 mm in the saline ondansetron group. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and september 1996. Study examines effects of taking ondansetron during first trimester of pregnancy 18 december 2018 credit. While fetal safety data for doxylaminepyridoxine are based on more than a quarter of a million pregnancies, the fetal safety data for ondansetron are based on fewer than 200 births. Ondansetron use in early pregnancy and the risk of congenital. This study, which included almost 90,000 firsttrimester ondansetron exposures, is the largest study of this issue and provides the most reassuring data. Ondansetron use in the management of nausea and vomiting in pregnancy is common up to 15%. Ondansetron in pregnancy and the risk of congenital. Importantly, a recent large control study by the slone epidemiology center in boston, mass, and the centers for disease control and prevention in atlanta, ga, detected a 2fold increased risk of cleft palate associated with ondansetron taken for nvp in the first trimester of pregnancy odds ratio 2. Ondansetron use in early pregnancy and the risk of.
Dec 06, 2019 ondansetron is commonly prescribed for nausea during early pregnancy. Ondansetron in pregnancy and risk of adverse fetal outcomes. A study from the slone epidemiology center at boston university, in collaboration with the centers for disease control and prevention cdc, found that taking ondansetron during early pregnancy did not appear to increase the chance of having a baby with a birth defect. May 05, 2020 mostly, the patients in the study were able to use less zofran gradually. Pdf ondansetron in pregnancy and risk of adverse fetal outcomes.
Ondansetron exposure changes in a pregnant woman lemon. Hyperemesis gravidarum is a more severe form of nausea and vomiting which occurs in less than 1% of pregnancies. Request pdf intravenous ondansetron in pregnancy and risk of congenital malformations a populationbased cohort study previously evaluated the association between firsttrimester exposure to. Ondansetron has also been prescribed during pregnancy to reduce symptoms of nausea and vomiting in pregnancy nvp. Rescue antiemetic therapy was given to 28%, 25%, and 45% of each group, respectively. Treatment of nausea and vomiting in pregnancy australian. Ondansetron use increased from webmd provides common contraindications for ondansetron hcl oral. Pdf ondansetron is frequently used to treat nausea and vomiting during pregnancy, but the safety of this drug for the fetus has not been well.