Feed your ‘pocket brain’
Feed your pocket brain’
The pocket brain is the newest feature of Drug Utilization Review. Here is this month’s item.1 Readers are encouraged to send suggestions for future items (with source noted) to the editor at [email protected].
Pregnancy Risk Factors
Pregnancy risk factors (A, B, C, D, and X) indicate the level of risk a drug poses to the fetus. They do not refer to the risk to a baby from breast-feeding. The definitions for these factors are those used by the Food and Drug Administration [44 Fed Reg 37,434-37,467 (1980)].
Category A: Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence 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 have shown an adverse effect (other than a decrease in fertility) that 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 there are no controlled studies in women, or studies in women and animals are not available. 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 life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Category X: Studies in animals or human beings 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 drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Reference
1. Briggs GG, Freeman RK, Yaffe SJ, eds. Drugs in Pregnancy and Lactation. 4th ed. Baltimore: Williams & Wilkins; 1994.
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