Word: pregnant
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...drug, metoclopramide, is not approved by the U.S. Food and Drug Administration (FDA) for use in pregnant women, but it is dispensed widely in Europe and other places to treat morning sickness. In the new study, the largest one of maternal metoclopramide use to date, involving nearly 3,500 babies born between 1998 and 2007 in a region in southern Israel, the rate of congenital birth defects in babies born to mothers who used the anti-nausea drug was about the same as that in babies whose mothers had not (5.3% vs. 4.9%). What's more, the length of time...
...treatment, since most expecting mothers and their doctors aren't keen on exposing a still developing fetus to medications. Now, researchers from Israel and Canada report in the New England Journal of Medicine that a commonly prescribed heartburn drug, which also has anti-nausea properties, may be used in pregnant women without causing harm to babies. (See safety issues about taking pills during pregnancy...
...prescribed metoclopramide more liberally, and Dr. Gideon Koren, director of the University of Toronto's Motherisk Program for the study of antenatal drugs, saw an opportunity to address divided concerns about the medication. Collaborating with a large HMO in Israel, he and his multinational colleagues studied metoclopramide use in pregnant women and its association with babies' health outcomes - specifically, birth defects, premature birth, low birth weight, Apgar score (which provides an immediate measure of a baby's physical condition at birth) and infant death...
...meantime, the FDA has proposed a massive overhaul of the guidance it gives on drug use by pregnant women. Prompted by a spate of birth defects caused by thalidomide, the notorious morning-sickness drug, the agency since 1979 has classified drugs in one of five pregnancy-related categories, with A being the safest and X being the least necessary (like Accutane, an acne treatment associated with birth defects). Category B has pretty positive safety data, and D encompasses chemotherapy and other drugs whose benefits may outweigh the risks to the fetus. And then there's Category C, which covers...
That's why the FDA is moving toward ditching these broadly defined categories in favor of a more narrative, evidence-based summary of what's known about an individual drug and its effect on pregnant and nursing women. "People are very uncomfortable with shades of gray," Feibus says, "and pregnancy is all gray." Of course, Second Wavers are hoping that won't always be the case...