Histrelin (implant) Pregnancy Warnings
Use is contraindicated.
US FDA pregnancy category: X
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.
-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 have revealed evidence of embryotoxicity and teratogenicity (e.g., spontaneous abortions, major fetal abnormalities, increased fetal mortality, decreased fetal weights, reduced fertility). There are no controlled data in human pregnancy.
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.
See references