Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Data are insufficient to determine a drug-associated risk of adverse developmental outcomes as women in the studies did not receive this drug during the first trimester of pregnancy; animal studies have revealed no evidence of harm to the fetus.

Comments:
-This drug is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

In animal studies, IM administration to pregnant rats at doses 5 times the human dose equivalent was not associated with adverse developmental outcomes. In clinical trials, the first dose was administered to women starting at 16 weeks gestation and continued until 37 weeks gestation or delivery. An ultrasound examination confirmed gestation age and no known fetal anomaly prior to initiating therapy. Compared to placebo, this drug reduced the rate of preterm delivery. Due to the higher rate of miscarriages and stillbirths in patients receiving this drug, there was no overall survival difference demonstrated compared to placebo. An infant follow-up study evaluating communication, gross motor, fine motor, problem solving, and personal/social parameters between those receiving the drug and placebo found the proportion of children whose scores met the screening threshold for developmental delay in each developmental domain were similar between groups.

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.

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This drug has been used without apparent harmful effects

Excreted into human milk: Yes

Comments:
-Published studies have reported no adverse effects on the breastfed child or on milk production.
-There is no indication after delivery, this drug should be discontinued at week 37 or upon delivery (whichever occurs first).

See references