Ridaura Pregnancy Warnings
This drug is embryotoxic and teratogenic in some animal species. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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.
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-Adequate methods of contraception should be encouraged.
-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.
-Women of childbearing potential should avoid becoming pregnant during therapy and for at least 6 months following the last dose.
See references
Ridaura Breastfeeding Warnings
Studies indicate that gold is excreted into maternal milk in small quantities and at least a small quantity is absorbed by the infant because it is detectable in urine. No overt cases of toxicity have been reported. Expert opinions vary from recommending avoidance to allowing use. If this drug is used during breastfeeding, the infant should be monitored closely. The manufacturer does not recommend use of this drug during breastfeeding.
Use is not recommended.
Excreted into human milk: Yes
Comments:
-This drug is excreted into breastmilk in quantities sufficient for there to be a risk to the child even at therapeutic doses.
-Trace amounts of this drug appear in the serum and red blood cells of the nursing infant which may cause unexplained rashes, nephritis, hepatitis, and hematological adverse effects.
See references
