Opsumit Pregnancy Warnings
Animal studies have revealed evidence of teratogenicity, embryofetal toxicity, and fetolethality. There are no controlled data in human pregnancy.
This drug, like other endothelin receptor antagonists (ERAs), may have an adverse effect on spermatogenesis.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
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: X
US FDA pregnancy category: Not assigned.
Risk Summary: There are risks to the mother and fetus associated with pulmonary arterial hypertension in pregnancy.
Comments:
-Females of reproductive potential must exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment.
-Treatment may be initiated in females of reproductive potential only after a negative pregnancy test.
-Pregnancy must be prevented during treatment and for one to three months after stopping treatment by using acceptable methods of contraception.
-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.
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