Dexrazoxane Pregnancy Warnings
Animal studies of administration during organogenesis showed teratogenicity (imperforate anus, microphthalmia, anophthalmia, skeletal malformations such as short tail, rib and thoracic malformations, soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, and agenesis of the gallbladder and the intermediate lobe of the lung) at approximately 0.1 and 0.2 times the human dose. Doses approximately 0.1 times the human dose also caused maternal toxicity. Administration of about 0.1 times the human dose during organogenesis also resulted in impairment of fertility for both male and female offspring. There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Comments:
-This drug can cause fetal harm; if this drug is used during pregnancy, or the patient becomes pregnant, apprise them of the potential hazard to the fetus.
-Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
-Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
See references
