Fetal Risk of Ethisterone During Pregnancy

Product name:Ethisterone

CAS:434-03-7

Molecular Formula:C21H28O2

Molecular Weight: 312.45g/mol

The FDA mandated deletion of pregnancy-related indications for all progestins because of a possible association with congenital anomalies. No reports linking the use of ethisterone alone with congenital defects have been located. The Collaborative Perinatal Project monitored 866 mother-child pairs with 1st trimester exposure to progestational agents (including 2 with exposure to ethisterone). An increase in the expected frequency of cardiovascular defects and hypospadias was observed for the progestational agents as a group, but not for ethisterone as a single agent. In a subsequent report from the Collaborative Study, a single case of tricuspid atresia and ventricular septal defect was identified with 3rd trimester exposure to ethisterone and ethinyl estradiol. Reevaluation of these data in terms of timing of exposure, vaginal bleeding in early pregnancy, and previous maternal obstetric history, however, failed to support an association between female sex hormones and cardiac malformations. An earlier study also failed to find any relationship with nongenital malformations.

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