PROPAFENONE

Fetal Risk Summary

Propafenone is an orally active antiarrhythmic used in the treatment of ventricular tachycardia. No teratogenic effects have been observed in studies with rabbits and rats, but propafenone was embryotoxic in both species when given in doses of 10 and 40 times the maximum recommended human dose, respectively (1).

Propafenone, in combination with b-methyldigoxin 400 µg/day, was administered to a 22-year-old woman between 24 and 26 weeks' gestation in an unsuccessful attempt to treat refractory fetal supraventricular tachycardia and hydrops fetalis (2). The daily dose of propafenone was 850 mg. Because transplacental passage of the antiarrhythmics was hindered by the fetal hydrops, successful resolution of the condition eventually required direct umbilical vein injections of amiodarone (see Amiodarone).

Breast Feeding Summary

No data are available.

References

1. Product information. Rythmol. Knoll Pharmaceuticals, 2000.
2. Gembruch U, Manz M, Bald R, Rüddel H, Redel DA, Schlebusch H, Nitsch J, Hansmann M. Repeated intravascular treatment with amiodarone in a fetus with refractory supraventricular tachycardia and hydrops fetalis. Am Heart J 1989;118:1335–8.