Use should be avoided

AU TGA pregnancy category: D

US FDA pregnancy category: Not assigned

Risk summary: There are no data in pregnant women to evaluate a drug associated risk; however, based on animal studies and its mechanism of action, this drug can cause fetal harm.

Comments:
-Pregnancy status should be verified prior to starting treatment.
-Women of childbearing potential should be advised of the potential risk to a fetus if this drug is used during pregnancy.
-Effective contraception should be used during treatment and for 1 week after the last dose.

Animal studies have shown administration during the period of organogenesis resulted in adverse developmental outcomes including embryofetal death and malformations at exposures less than or equivalent to those expected with recommended doses. In rats, adverse developmental outcomes included increases in fetal weights which may be related to increased ossification (i.e., increased rate of development); malformations included cleft palate, anasarca (edema), and cardiac abnormalities. In rabbits, increases in early resorptions and post-implantation loss, decreases in the number of live fetuses, and cardiac malformations were observed. There are no controlled data in human pregnancy.

Based on findings in animals, this drug may impair female fertility; the reversibility of the effect on fertility is unknown.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

See references

Breastfeeding is not recommended during use of this drug

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Because of the potential for serious adverse reactions, women should not breastfeed during treatment and for 1 week after the last dose.
-The effects on the breastfed child or on milk production are unknown.

See references