Many pregnant or nursing people are struggling to get solid evidence-based information from their doctors and midwives about the safety of taking specific medications during pregnancy. Often a request for clarification from their maternity healthcare provider results in the suggestion to talk to the prescribing doctor. Alternately, the non-obstetrical provider simply refers all such questions to the lactating or pregnant person's OB or midwife. No medical provider wants to go down on record with concrete suggestions about what medications are safe to take during pregnancy or during nursing.

Meanwhile, the pregnant or breastfeeding person often gets confused, misdirected or incomplete information. Their only next step is to try and do research on their own, using the big, bad internet, which may or may not provide accurate information. Face it, relatively few medications are truly tested on pregnant people. Such research studies are very difficult to do, as no one really wants to test things that may ultimately be unsafe for a fetus or infant. The consequences of this extreme lack of information boil down to realizing that almost all the medicines that might be used by a pregnant person are considered an off-label use.

In recognition of this situation, the National Institutes of Health, as part of the 21st Century Cures Act, have created a task force to study this issue, take testimony from pregnant and breastfeeding people and work toward a solution that may help decrease the problems created by current practice and lack of information. After a coordinated effort, the PRGLAC (Research Specific to Pregnant Women and Lactating Women) task force will provide recommendations to the HHS Secretary on how to improve the development of safe and effective therapies for pregnant and nursing people, as well as guidance on how to best collaborate and coordinate these activities at the federal level.

According to Lawrence Tabak, D.D.S., Ph.D. NIH Principal Deputy Director, pregnant women take between three and five medications, but very little research has been conducted on the appropriate dosing, safety, and efficacy in pregnant or nursing women. Among other responsibilities, the task force is tasked with developing a plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant and lactating women.

Task force experts acknowledge that the state of knowledge about prescription medications used in pregnancy and breastfeeding, their impact, determining effective and safe dosing, maternal-fetal and maternal-infant drug transfer is sparse.

Important issues include understanding how physiological changes during pregnancy affect the effectiveness of drugs. Basic science is lagging in this area, such as pharmacokinetic and pharmacodynamics studies. Little is known about how pregnancy affects the metabolism of medications used. There is still a fear that inclusion of pregnant people in research studies will lead to a higher incidence of birth defects in their offspring. This must be balanced against the concern about short- and long-term consequences for the person if they decide to stop taking medications during pregnancy or while breastfeeding. Very few studies specifically include lactating parents, making it virtually impossible to advise them about drugs used postpartum. One issue is how to determine drug exposure levels to the baby received through breast milk; assays are difficult to develop.

StatNews covered this topic well in their in-depth article "Pregnant Women who need medications face a risky guessing game. A federal task force is now trying to help." They also interviewed people about their experiences. One woman said "I was on Zoloft for many years before I became pregnant with my first. Both my psychiatrist and OB/GYN would not give me an answer about if I should continue to take it.'

You can also find a great video on this topic on the Stat website.

Lamaze member Susan Givens, RNC-OB, MPH, LCCE, Lamaze International Lead Nurse Planner, has been selected to serve on this task force and help them reach their goals of better information for pregnant and nursing parents as well as the healthcare providers who serve them. Susan shares that it is very difficult to reassure people about the safety of medications taken during pregnancy and lactation because the data just aren't there. I am happy to be serving on The Task Force on Research Specific to Pregnant Woman and Lactating Women (PREGLAC), an NIH Task Force charged to change that. It is heartbreaking to hear the testimony of people with chronic health conditions who must take medications during pregnancy and lactation, despite having no information on how those medications could potentially affect their babies.

What can a childbirth educator do to help?

As childbirth educators and birth professionals, we often hear the families we work with discussing this situation and express their frustration with the lack of information and their fear of having to navigate this topic without professional help. LCCE Susan Givens provides some information on what childbirth educators can do:

• Be aware that there is a lot of conflicting information online about the safety of over-the-counter and prescription medications during pregnancy. A headliner story about the connection between a medication and potential behavioral effects on a child can bring a pregnant person weeping into your classroom. Let your students know that a one-off study alone does not provide the full safety profile of a medication. These stories are designed to draw in readers and they do!
• Encourage families to talk to their healthcare providers (HCPs) about any medications and herbal supplements they are taking so they can decide together the way forward based on the best information available.
• Explain that pregnant people should not stop prescription medications for chronic health conditions like hypertension, diabetes, depression, and seizure disorders until they talk with their HCP. The consequences of not taking certain medications for their health may outweigh potential risks.
• Bring to class a few empty over-the-counter and prescription medication bottles and help students learn to read safety information. The FDA has recently changed drug labels to better explain risks to pregnant and breastfeeding people. This replaces the old and confusing five letter system ((A, B, C, D, and X). Help the group discover where to find labeling information about pregnancy registeries (see also below).
• Suggest that they may wish to enroll in a pregnancy registry if one exists for the medication being taken. This helps to become part of a better understanding of the effects of certain exposures during pregnancy by contributing to this research. The FDA maintains a list of such registries.
• Encourage them to visit this FDA website for more information about medications during pregnancy and lactation.

I look forward to learning more about the work of this PRGLAC task force and having families worldwide benefit from their finished product.

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