Soltamox Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: B3
US FDA pregnancy category: D
Comments:
-This drug can harm a developing fetus.
-Women should be advised not to become pregnant while taking this drug or within 2 months of discontinuing therapy and should use barrier or nonhormonal contraceptive measures if sexually active.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies of doses at or below equivalent human doses have revealed evidence of fetotoxicity, lower incidence of implantation, and an increased incidence of low birth weight. There are no controlled data in human pregnancy; however, the manufacturer reports spontaneous abortions, birth defects, fetal deaths, and vaginal bleeding associated with this drug during pregnancy.
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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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