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Business & Regulation Clinical Trials, Small Molecules, Standards & Regulation

Including Pregnant Women from the Start

During my time as chair of the PRGLAC task force, I worked with and spoke to industry representatives and those in the private sector about the barriers to gathering data on medicines in pregnancy. One of the key things I kept hearing (something that we as clinicians are very aware of) is that it’s very uncommon for there to be medications that are specially tested in pregnant women. And for lactating women the problem is doubled, with incredibly limited information. And yet, we routinely prescribe medications during pregnancy and lactation. It’s a complex area: on one side, people say, “You should not test in pregnant or lactating women because of the potential risks and liability.” But you hear a similar argument on the other side – “in pregnancy, it’s very important to know what would be appropriate to take and what to avoid, because of the developing fetus.”

The reality, in the US at least, is that if a medication is approved for women of reproductive age for a condition that continues in pregnancy – such as hypertension or asthma – it is being used on-label, as described by representatives from the FDA at the PRGLAC meetings. But we have limited or no dosing recommendations and limited data, even though we know that a women’s physiology during pregnancy and lactation is different – blood volume doubles, there’s change to the binding proteins in the blood, GI transit time is different, as are kidney and liver function… and all of these changes could affect how a drug is bound, processed or cleared by the body.

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About the Author

Catherine Spong

Catherine Spong is Professor and Vice Chair, Obstetrics and Gynecology; Division Chair, maternal-fetal medicine UT Southwestern Medical Center, Dallas, Texas and Former Chair of Prglac.

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