Reproductive toxicology
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Reproductive toxicology · Jun 2019
Meta AnalysisUse of ondansetron during pregnancy and the risk of major congenital malformations: A systematic review and meta-analysis.
To investigate whether ondansetron use during pregnancy is associated with increased rates of major or subgroups of malformations. ⋯ Ondansetron use during pregnancy was not associated with a significant increase in rate of major or selected subgroups of malformations in our primary analysis. However, results of the secondary analyses warrant the need for continued surveillance. These results may be reassuring for pregnant women in whom ondansetron use is clinically indicated since the absolute risks of possible concerns appear to be low.
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Maternal mortality is a major global concern. Although a notable decline in maternal mortality in the United States occurred during the mid-20th century, this progress stalled during the late 20th century. Furthermore, maternal mortality rates have increased during the early 21st century. ⋯ This overview will try to provide a context for understanding the problem of this rise in maternal mortality in the U. S. by briefly discussing how maternal mortality rates are reported from National Vital Statistics data and from a National Surveillance system. Trends and causes of maternal deaths and the difficulty with interpreting these trends will be discussed.
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Reproductive toxicology · Aug 2015
ReviewEndothelin-1 receptor antagonists in fetal development and pulmonary arterial hypertension.
The Pregnancy Prevention Program (PPP) is in place to prevent drug-induced developmental malformations. Remarkably, among the ten PPP-enlisted drugs are three endothelin-1 (ET-1) receptor antagonists (ERA's: ambrisentan, bosentan and macitentan), which are approved for the treatment of Pulmonary Arterial Hypertension (PAH). ⋯ While ERA's hamper pathological remodeling of the pulmonary vasculature and as such exert beneficial effects in PAH, they disturb fetal development of cardiopulmonary tissues. By blocking ET-1-mediated positive inotropic effects and myocardial fetal gene induction, ERA's may affect right ventricular adaptation to the increased pulmonary vascular resistance in both the fetus and the adult PAH patient.
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Reproductive toxicology · Aug 2015
ReviewUse of juvenile animal studies to support oncology medicine development in children.
Childhood cancer has remained a challenge because of long-term effects in children. The need to extend access of children into new cancer therapies requires early prediction of specific safety aspects and juvenile animal studies (JAS) are being conducted to screen for age-related toxicities and differences occurring during postnatal development. ⋯ For 6 of the cancer medicines with JAS the toxicity profile in adult and juvenile animals showed some differences in study findings. The discussion of these cases is illustrative of the potential significance that JAS have provided in oncology medicines.
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Reproductive toxicology · Apr 2015
Review Meta AnalysisExposure to fluconazole and risk of congenital malformations in the offspring: A systematic review and meta-analysis.
Vulvovaginal candidiasis (VVC) affects up to 75% of women at least once during their lifetime, mostly during the reproductive age, and recurrence rate is about 50%. Because half of all pregnancies are unplanned and pregnant women have an increased risk of VVC recurrence, the likelihood of inadvertently being exposed to fluconazole in pregnancy is increased. ⋯ In conclusion, the use of fluconazole in the first trimester does not appear to increase the overall risk for congennital malformations. More studies are needed to address the potential increased rate of heart defects.