Streptokinase Pregnancy and Breastfeeding Warnings

Brand names: Kabikinase, Streptase

Streptokinase Pregnancy Warnings

Streptokinase (SK) has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted with SK. Successful use of streptokinase during human pregnancy without adverse fetal effects has been reported. There are no controlled data in human pregnancy. Streptokinase should be given during pregnancy only when benefit outweighs risk.

The human placenta essentially prevents passage of SK to the fetus. The minimal amount of SK that reaches the fetal circulation is not enough to cause fibrinolytic effects in the fetus. There are no reports of adverse effects on the fetus associated with the use of SK. Although little SK crosses the placenta, pregnancy is considered a minor contraindication to the use of SK, and obstetrical delivery within 10 days is considered a major contraindication.

Antibodies to SK cross the human placenta. Passive sensitization with anti-SK antibodies would have clinical importance only if the newborn subsequently required thrombolytic therapy with this drug.

In one study, 24 patients with deep vein thrombosis were treated with SK in the second and third trimesters without fetal complications.

Pfeifer has reported the successful use of SK to treat deep vein thrombosis and acute pulmonary embolism in a limited number of patients. Pfeifer also reports the use of SK to treat placental insufficiency in a single case (controversial indication). There is no mention of fetotoxicity or teratogenicity from these data.

Cases of acute massive pulmonary embolism during pregnancy that were successfully treated by SK without adverse effects on the fetus have been reported. When SK was administered near delivery, slow but severe postpartum hemorrhage (due to the thrombolytic state) and/or partial uterine atony (thought to be due to fibrin degradation products) have been reported.

In one case (McTaggart and Ingram, 1977), SK was used to treat massive pulmonary embolism associated with shock in a 24-year-old woman at 34 weeks' gestation. Fetal heart sounds were absent eight hours after admission and between four and eight hours after streptokinase was started. After an otherwise uneventful recovery, the patient spontaneously delivered a stillborn female 18 days later.

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