Simplified Summary of FDA Use-in-Pregnancy Ratings
. Human studies have failed to demonstrate a risk to the fetus.
. Human studies may or may not have been done. Animal studies may or may not have shown fetal risk. Chance of fetal harm is possible.
. Human studies are lacking. Animal studies have shown risk or are also lacking. Chance of fetal harm.
. Human studies have demonstrated risk. Potential benefits from the use of the drug may outweigh the potential risk.
. Human and animal studies have demonstrated positive evidence of fetal abnormalities or risks which outweigh any possible benefits to the patient.
Epidemiology & Evaluation Section
Maternal, Child, & Adolescent Health Branch
California Department of Health Services