Off-label prescribing during pregnancy

Abstract

Obstetricians frequently prescribe drugs for indications other than those on the product label. Reasons for such off-label use during pregnancy include prevention of repetitive abortion, inhibition of premature labor, reduction of fetal or neonatal infection, reduction in development of preeclampsia and its complications, and ripening of the cervix or induction of labor. A physician has a legal right to prescribe for off-label indications despite regulatory, manufacturer, and cost constraints. Such prescribing habits would not be considered experimental if based on sound scientific evidence. Adequate and well-controlled studies are difficult, however, to perform during pregnancy. Evidence of widespread use and support from another qualified clinician are methods of justifying off-label prescribing. Each patient is entitled to know why she and her fetus would benefit from the treatment and whether any unnecessary risk is anticipated. Legible documentation of these discussions in the medical records is important.