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Páginas: 3 (667 palabras) Publicado: 13 de noviembre de 2012
FDA PREGNANCY CATEGORIES
The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows: Category A Adequate and well-controlled studies have failed to demonstrate a risk to thefetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are noadequate and well-controlled studies in pregnant women. Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies inhumans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category D There is positive evidence of human fetal risk based on adverse reaction data frominvestigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category X Studies in animals or humans havedemonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug inpregnant women clearly outweigh potential benefits.

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MEDICATION EXPOSURES DURING PREGNANCY AND LACTATION
Every woman in the general population has a 3–5% risk of having a child with a birthdefect or mental retardation. Birth defects are the leading cause of infant mortality in the United States. Two important factors to consider when assessing the teratogenic potential of a medicationare the stage of pregnancy at which the exposure occurred and the amount of medication taken. It is critical to evaluate each exposure on a case-by-case basis in order to give an accurate riskassessment. Some of the known, possible, and unlikely human teratogens are listed below. If you have a pregnant or breast feeding patient who is currently taking, or considering taking, a medication, the...
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