Trelstar Pregnancy Warnings
In animal studies, daily administration of this drug during the period of organogenesis caused maternal toxicity and embryofetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings in animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with this drug increase the risk for pregnancy loss.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Women of childbearing potential should use effective non-hormonal contraception during therapy until menses resume.
-This drug may impair fertility in males of reproductive potential.
-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 hazard to the fetus.
See references
