Teratological, peri- and postnatal studies on Ferastral, an iron-poly(sorbitol-gluconic acid) complex
| Autor: | H. Flodh, T. Malmfors, Göran Magnusson |
|---|---|
| Rok vydání: | 1977 |
| Předmět: |
Litter (animal)
medicine.medical_specialty Necrosis medicine.medical_treatment Iron Spleen Biology Gluconates Injections Intramuscular Pregnancy Internal medicine Lactation Placenta Fibrinolysis medicine Animals Sorbitol Fetal Viability Blood Coagulation reproductive and urinary physiology Dose-Response Relationship Drug Abnormalities Drug-Induced Hematology Fetal Resorption medicine.disease Teratology Rats Drug Combinations medicine.anatomical_structure Endocrinology Liver Pregnancy Animal Female Iron-Dextran Complex Rabbits medicine.symptom |
| Zdroj: | Scandinavian journal of haematology. Supplementum. 32 |
| ISSN: | 0080-6722 |
| Popis: | This paper presents a review of the teratological and peri- and postnatal studies performed in rats and rabbits on Ferastral®, an iron-poly (sorbitol-gluconic acid) complex. The test compound was given intramuscularly in doses varying from 1 to 100 mg Fe3+/kg. In the teratological studies the compound was given daily during the whole or part of the period of organogenesis, and in the peri- and postnatal study in rats from day 16 of pregnancy through lactation to 21 days post partum. In a separate study the effects of Ferastral® on blood coagulation and fibrinolysis were studied in pregnant rats treated with 50 mg Fe3+/kg. Jectofer® (iron-sorbitol) and Imferon® (iron-dextran) were used as reference compounds in some of the studies. Pregnant rats reacted in a totally different way compared to pregnant rabbits when treated with high doses of Ferastral. Pregnant rats, but not rabbits, developed focal necrosis in the liver, placenta and spleen. These changes were dose-dependent and not observed with lower doses (1, 4 and 16 mg Fe3+/kg). Similar pathological alterations were also seen after treatment with Jectofer, but not with Imferon. The pathological changes, being similar to those seen after elicitation of a generalized Shwartzman reaction (GSR), were not interpreted as an expression of such a reaction. The most common features of the GSR, bilateral cortical necrosis, capillary thrombi, and changes in the blood coagulation and fibrinolytic activity, were not observed in the pregnant rats. The maternal toxicity was accompanied by secondary effects on the foetuses manifested in reduced maturation of the foetal skeleton. Treatment with Ferastral in doses not inducing maternal toxicity did not adversely affect litter size, foetal loss, litter weight or embryonic or foetal development in either rats or rabbits. |
| Databáze: | OpenAIRE |
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