Somavert Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Reduction in IGF-I can potentially increase fertility in female patients; advise use of adequate protection during treatment if needed.
Animal studies of subcutaneous administration of 1, 3, or 10 mg/kg/day during organogenesis showed no teratogenicity, but the 10 mg/kg/day dose (10 times the maximum recommended human dose) caused a slight increase in post-implantation loss. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
