With evidence on drug safety in pregnancy sorely lacking, pressure is mounting to change the status quo. LongReads
, first approved in the United States in 1991. It looked promising: Experiments in rats by several groups showed that pravastatin reduced the risk of preeclampsia without apparent downsides. Beginning in 2012, FDA permitted pilot studies, and over time Costantine enrolled 40 pregnant patients who’d had severe preeclampsia in a prior pregnancy, leaving them at high risk of a repeat. Nine of 20 in the placebo group developed the condition, compared with two of 20 in the treatment group.
Moving pravastatin, a drug approved long ago, into pregnancy trials has been hard enough. With experimental therapies, the hurdles loom even higher. There can be “a huge liability issue” if a pregnant study volunteer has a baby with a birth defect, for example, says Marie Teil, a clinical trialist with experience in research ethics. She was hired by UCB Biopharma, a pharmaceutical company in Belgium, to help it learn how to study its products in pregnant and breastfeeding people.
a laundry list of recommendations to the Secretary of Health and Human Services and Congress in September 2018 , she be followed and even offered the chance to continue on the study medication if that had been her assigned group. “We have tried very hard to improve in that space,” Yao says of FDA’s policies. Among other efforts, the agency is also trying to craft strategies to better communicate risk and research findings to physicians caring for these patients.
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