Microsoft Word Risk Factors.doc

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1 Risk Factors ssigned to all drugs, base Risk Factors (A, B, C, D, X) have been a d on the level of risk the drug poses to the fetus. Risk Factors are de signed to help the reader quickly classify a drug for use during pregnancy. They do not re fer to breast-feeding risk. Because they tend to oversimplify a complex topic, they shou ld always be used in conjunction with the Fetal Risk Summary. The definitions for the Factors are those used by the Food and Drug Administration (Federal Regi ster 1980;44:37434-67). Since most drugs have not yet been given a letter rating by their manufactures, the Risk Factor assignments were usually made by the authors. If the manufacturer rated its product in its profe ssional lite rature, the Risk Factor on the monograph will be shown with a subscript M (e.g., C If the M). manufacturer and the authors differed in th eir assignment of a Risk Factor, our Risk nufacture’s rating is shown at the end of the Factor is marked with an asterisk and the ma t different risks to the fetus, depending on amides, morphine, etc.) are drugs that presen when or for how long they are used. In thes e cases, a second Risk Factor will be found with a short explanation at th e end of the Fetal Risk Summar y. We hope this will increase the usefulness of these ratings. The definitions used for the Risk Factors are presented below. Category A: Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no eviden ce of a risk in later trimesters), and the possibility of fetal harm appears remote. Category B: Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies ecrease in fertility) th have shown an adverse effect (other than a d at was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters). Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal, or other) and th ere are no controlled studies in women or studies in women and animals are not availa ble. Drugs should be given only if the potential benefit justifies the potential risk to the fetus. Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a r a serious disease for which safer drugs cannot be used or life-threatening situation or fo are ineffective). Category X: Studies in animals or human be ings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the dr ug in pregnant women clearly out weighs any possible benefit. The drug is contraindicated in wome n who are or may become pregnant. th edition Drugs in Pregnancy and Lactation Briggs et.al. 4

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