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US Food and Drug Administration (FDA) Categories for the Use of Medications in Pregnancya FDA category Definition A Controlled studies in animals and women have shown no risk in the first trimester, and possible fetal harm is remote Either animal studies have not demonstrated a fetal risk, but there are no controlled studies in pregnant women, or animal studies have shown an adverse effect that was not confirmed in controlled studies in women in the first trimester No controlled studies in humans have been performed, and animal studies have shown adverse events, or studies in humans and animals are not available

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