The FDA-assigned pregnancy categories as used in the Drug Formulary
Adequate and well-controlled studies have failed to demonstrate a riskto the fetus in the first trimester of pregnancy (and there is no evidenceof risk in later trimesters).
Animal reproduction studies have failed to demonstrate a risk to thefetus and there are no adequate and well-controlled studies in pregnantwomen.
Animal reproduction studies have shown an adverse effect on the fetusand there are no adequate and well-controlled studies in humans, butpotential benefits may warrant use of the drug in pregnant womendespite potential risks.
There is positive evidence of human fetal risk based on adversereaction data from investigational or marketing experience or studiesin humans, but potential benefits may warrant use of the drug inpregnant women despite potential risks.
Studies in animals or humans have demonstrated fetal abnormalitiesand/or there is positive evidence of human fetal risk based on adversereaction data from investigational or marketing experience, and therisks involved in use of the drug in pregnant women clearly outweighpotential benefits.
Every woman in the general population has a 3–5% risk of having a child
with a birth defect or mental retardation. Birth defects are the leading causeof infant mortality in the United States. Two important factors to considerwhen assessing the teratogenic potential of a medication are the stage ofpregnancy at which the exposure occurred and the amount of medicationtaken. It is critical to evaluate each exposure on a case-by-case basis inorder to give an accurate risk assessment.
Some of the known, possible, and unlikely human teratogens are listed
below. If you have a pregnant or breast feeding patient who is currentlytaking, or considering taking, a medication, the patient needs to be coun-seled about potential adverse effects the medication could have on her fetusor infant. This counseling needs to be documented in the patient’s chart.
CARE (Counseling and Advice on Reproductive Exposures) Northwest
provides health care professionals and patients with comprehensive up-to-date information on the potential risks associated with exposure to drugs andchemicals during pregnancy and lactation. CARE Northwest serves tobridge the gap between an often conflicting and limited body of publishedliterature and the practitioner who must respond to patients’ concerns aboutdrug exposures during pregnancy. In-clinic evaluations can be requested forcomplex cases and written risk assessments are available for inclusion in thepatient’s medical record when warranted.
UWMC and HMC practitioners can access a trained counselor at CARE
Northwest by dialing toll-free (888) 616-8484.
Some Known Teratogens
• Maternal & Metabolic Imbalance
Some Known Teratogens
• Drugs and Environmental
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