Colesevelam hydrochloride does not cause maternal or fetal toxicity in rats and rabbits
| Autor: | Judith K. Marquis, Michael R. Jones, Brian A. Baker, Rafif Dagher |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Male
medicine.medical_specialty medicine.drug_class Colesevelam Hydrochloride Developmental toxicity Growth Biology Toxicology Allylamine Rats Sprague-Dawley Eating Fetus Pregnancy Bile acid sequestrant Internal medicine Lactation medicine Animals Birth Weight Maternal Behavior Fetal viability Colesevelam Anticholesteremic Agents Reproduction Body Weight Rats Endocrinology medicine.anatomical_structure Animals Newborn Toxicity Gestation Female Rabbits medicine.drug |
| Zdroj: | Reproductive Toxicology. 21:197-207 |
| ISSN: | 0890-6238 |
| DOI: | 10.1016/j.reprotox.2005.07.014 |
| Popis: | WelChol ® (colesevelam hydrochloride), a bile acid sequestrant for the treatment of hypercholesterolemia, was evaluated for adverse effects on reproduction and fetal development using standard preclinical tests. During gestation, Sprague–Dawley rats used in the developmental toxicity study received feed, feed/control article or feed plus 300, 1000 or 3000 mg/kg/day colesevelam whereas rats in the pre- and postnatal toxicity study received vehicle or 100, 300 or 1000 mg/kg/day colesevelam via gavage. New Zealand white rabbits received control or 100, 500 or 1000 mg/kg/day colesevelam via gavage. No deaths, premature deliveries or gross pathologic lesions were observed up to gestation day (GD) 20 for rats and GD 28 for rabbits. No significant differences in the number of pregnant animals, average litter size, percentage of viable fetuses, fetal body weights, number of corpora lutea, fetal viability, or gross malformations were observed versus controls. Pre- and postnatal effects were assessed in pregnant rats receiving 100, 300 or 1000 mg/kg/day colesevelam from GD 6 to postpartum day 22. Gestation, parturition and lactation in F 0 generation dams were similar between treatment and control groups. Colesevelam did not affect physical or neurological development or induce gross pathological changes in F 1 generation rats. Colesevelam does not produce developmental toxicity in rats or rabbits, nor does it exhibit pre- or postnatal toxicity in rats at the tested doses. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect