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Pregnancy Categories
Question | Answer |
---|---|
Category A | Controlled studies showed no risk to the fetus; adequate well-controlled studies in pregnant women have not demonstrated risk to the fetus |
Category B | there is no evidence of risk in humans; animal studies how risk, but human findings do not |
Category C | risk cannot be ruled out; human studies are lacking and animal studies are either positive or fetal risk or lacking; the drug may be used during pregnancy if the potential benefits of the drug outweigh its possible risks |
Category D | There is positive evidence of risk to the human fetus; Investigational or postmarketing data show risk to the fetus; Howver potential benifits may outweigh the risk to the fetus. If needed in a life-threatening situation or a serious disease the drug may |
Category X | Use of the drug is contraindicated |