Word: fda
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Dates: during 2000-2009
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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...
...childbearing, more moms-to-be are struggling with cancer. So it's hardly surprising that two-thirds of women take up to five drugs over the course of their pregnancy and labor. Yet only a dozen prescription drugs are approved for use by the U.S. Food and Drug Administration (FDA) during pregnancy, and they're all pregnancy-related: drugs for inducing labor, for example, or epidural anesthesia. Which means patients with many common conditions face an excruciating dilemma: decline medication whose effects on a fetus may be largely unknown or take it and worry about the consequences...
...psychiatric evaluation - in order to get the medications she sought. "It was very frustrating," says Sosnader, 45, a logistics manager for Procter & Gamble in Worcester, Pa. "Everyone had their own opinion about what I should do, but there were no facts to support any of it." (See how the FDA classifies drugs and their effects on pregnancy...
...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...