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Stahl's Essential Psychopharmacology Online
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Stahl's Essential Psychopharmacology

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FDA Use-In-Pregnancy Ratings

Category A: Controlled studies show no risk: adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the fetus
Category B: No evidence of risk in humans: either animal findings show risk, but human findings do not; or, if no adequate human studies have been performed, animal findings are negative
Category C: Risk cannot be ruled out: human studies are lacking, and animal studies are either positive for fetal risk or lacking as well. However, potential benefits may outweigh risks
Category D: Positive evidence of risk: investigational or postmarketing data show risk to the fetus. Nevertheless, potential benefits may outweigh risks
Category X: Contraindicated in pregnancy: studies in animals or humans, or investigational or postmarketing reports, have shown fetal risk that clearly outweighs any possible benefit to the patient
 

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