Urokinase Pregnancy and Breastfeeding Warnings
Urokinase Pregnancy Warnings
Urokinase has been assigned to pregnancy category B by the FDA. Animal data have failed to reveal evidence of teratogenicity or fetotoxicity. There are no controlled data in human pregnancy. Urokinase should only be given during pregnancy when benefit outweighs risk.
Two cases in which urokinase was successfully and safely used to treat pulmonary emboli (PE) and two cases in which the drug was successfully and safely used to treat deep venous thrombi (DVT) during human pregnancy have been reported. In one case of acute PE, thrombolytic therapy was chosen for the treatment of PE in a 19-year-old at gestational age 29.2 weeks' because of the woman's tenuous hemodynamic status. The patient was given 4,400 intl units/kg over 10 minutes followed by a maintenance infusion of 4,400 intl units/kg per hour for 12 hours. Therapy was dramatically successful; the only complication was mild, self-limited macroscopic hematuria. A heparin infusion was begun at the end of urokinase therapy, and adjusted to maintain a partial thromboplastin time at one and one-half to two times the control value. The patient was discharged with subcutaneous heparin therapy. Aside from two brief hospital readmissions for adjustment of anticoagulant therapy, she did well. She subsequently had an uncomplicated vaginal delivery of a healthy term infant. Thrombolytic therapy using urokinase was chosen for the treatment of PE in a 20-year-old at 21 weeks' gestation because of clinical deterioration during heparin therapy. This patient was given the same regimen as in the case above, and showed marked hemodynamic improvement over the ensuing 12 hours. A second urokinase bolus was given for recurrent PE 6 hours later. The patient continued to receive subcutaneous heparin during the rest of her pregnancy. She delivered a healthy male infant (3,122 g) at term. Lower extremity DVT per history, physical and MRI was successfully treated in a heparinized 23-year-old woman at 33 weeks' gestation after urokinase 5,000 intl units/hr over 36 hours + dipyridamole. Six weeks after the urokinase infusion, the patient delivered a normal 3,540-gram male infant vaginally without complications. Upper extremity DVT per history, physical, and Doppler ultrasound was successfully treated in a heparinized 18-year-old woman at 11 weeks' gestation after urokinase + heparin therapy. Follow-up Doppler ultrasound shown recanalization of the problem vein, and, 7 months later, the patient delivered a normal 3,140-gram male infant.
Urokinase Breastfeeding Warnings
There are no data on the excretion of urokinase into human milk. The manufacturer recommends that caution be used when administering urokinase to nursing women.
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