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Psychotropic Medication Use Among Women Initiating Prenatal Care in the California Medicaid Program, ... - page 4 / 19

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Simplified Summary of FDA Use-in-Pregnancy Ratings

Category A - Controlled studies show no risk. Human studies have failed to demonstrate a risk to the fetus.

Category B - No evidence of risk in humans. 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.  

Category C - Risk cannot be ruled out. Human studies are lacking. Animal studies have shown risk or are also lacking. Chance of fetal harm.

Category D - Positive evidence of risk. Human studies have demonstrated risk. Potential benefits from the use of the drug may outweigh the potential risk.

Category X - Contraindicated in Pregnancy. 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

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