Reproductive toxicology
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Reproductive toxicology · Jun 2015
Developmental toxicity assessment of tanezumab, an anti-nerve growth factor monoclonal antibody, in cynomolgus monkeys (Macaca fascicularis).
Two intravenous studies with tanezumab, an anti-nerve growth factor monoclonal antibody, were conducted in pregnant cynomolgus monkeys to assess potential effects on pregnancy and pre- and postnatal development. Study 1 evaluated infants up to 12 months of age following weekly maternal dosing (0, 0.5, 4 or 30 mg/kg; 18 per group) from gestation day (GD) 20 through parturition. ⋯ Decreased primary antibody responses and increased incidences in skin changes in infants were also observed. The no-observed-adverse-effect-level for maternal toxicity was 30 mg/kg and <0.5 mg/kg for developmental toxicity.
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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.
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Ondansetron use for nausea and vomiting during pregnancy has increased in the last years, although its maternal and fetal safety is not conclusive. ⋯ The spontaneous reporting system of WHO confirms that this potentially life threatening complication is more common than what the peer review literature may suggest and needs to be looked into carefully, especially in view of the wide spread off-label use for NVP.
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Reproductive toxicology · Dec 2014
Use of ondansetron during pregnancy and congenital malformations in the infant.
The study investigates teratogenic risks with ondansetron (Zofran(®)). Data from the Swedish Medical Birth Register combined with the Swedish Register of Prescribed Drugs were used to identify 1349 infants born of women who had taken ondansetron in early pregnancy, 1998-2012. Presence of congenital malformations in the offspring was identified with three national health registers. ⋯ No statistically significantly increased risk for a major malformation was found. The risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant (OR=1.62, 95% CI 1.04-2.14, and RR 2.05, 95% CI 1.19-3.28, respective). The teratogenic risk with ondansetron is low but an increased risk for a cardiac septum defect is likely.
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Reproductive toxicology · Apr 2013
Comparative StudyEvaluation of genotoxicity in leukocytes and testis following intra-vasal contraception with RISUG and its reversal by DMSO and NaHCO₃ in Wistar albino rats.
Evaluation of genotoxicity of RISUG® - a vas based contraceptive, was carried out in the present study. Animals were allotted into groups of sham operated control, vas occlusion with RISUG (5-7 μl) for 360 days and reversal by DMSO (250-500 μl) and 5% NaHCO₃ (500 μl). Blood samples and testis were collected at 360 days of vas occlusion and 90 days of vas occlusion reversal for comet analysis. ⋯ Olive moment, tail length and percentage DNA in tail were recorded with minimum variation in all groups for both leukocytes and testis. When compared with positive control the variation was highly significant for both 20 μM and 50 μM H₂O₂ (p<0.001). It is concluded that vas occlusion with RISUG at the contraceptive dose regimen is not associated with genotoxicity in leukocytes or the testis of pre- and post-reversal rats.