how safe is medication during pregnancy? health pregnancy hub aims to tackle misinformation for expectant mothers
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in many ways, pregnant women are very similar to their peers who are not pregnant in terms of the types of conditions they have and treatments, but in pregnancy, there’s always a worry about the child.
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are pregnant women getting the treatment they need?
when it comes to medication, there’s misinformation and fear surrounding taking any medication during pregnancy that may affect an unborn child. the knowledge gap is a challenge that the pan-canadian women’s health coalition, coordinated by the canadian partnership for women and children’s health (canwach), has taken on. the coalition brings together 10 national research hubs advancing women’s health through research, innovation and community partnerships.
“people think that pregnant women don’t use medications. this is absolutely false,” says dr. anick bérard, women’s health researcher, professor of perinatal epidemiology at the university of montreal and principal investigator of the healthy pregnancy hub, one of the coalition’s research hubs. the hub is dedicated to providing resources to the public and healthcare providers for informed discussions on risks and benefits of medications, including vaccines, during pregnancy.
a team of 90 national researchers and more than 2,000 patient partners are driving the hub’s mission to provide accessible information based on scientific research.
“we know that 75 per cent of pregnant women in canada, so this is canadian data, will use medication at one point in time in their pregnancy, either to treat a chronic condition that they had beforehand, like depression, anxiety, asthma and autoimmune disease,” dr. bérard explains. “so if they have epilepsy or type 2 diabetes, they become pregnant, and now they have to manage: ‘do i treat? do i continue my meds? do i stop?’”
the other part of the issue is conditions triggered by pregnancy, like nausea and vomiting, urinary tract infection and gestational hypertension or gestational diabetes.
medication, as a result, ranges widely from acetaminophen to antiepileptic drugs.
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women excluded from clinical trials
bérard notes that all these medications were approved by health canada, but they were approved to be sold and prescribed with zero data on pregnant women. yes, there are animal studies on medications used in pregnancy, but these can’t predict what’s going to happen in human pregnancy. the worst-case example is thalidomide, which seemed like the ideal drug to treat morning sickness in pregnant women in the 1950s, but then children were born with terrible limb birth defects.
looking back 20 to 30 years in medical research, women in general were excluded from clinical trials because the thought was “women are complicated, and they might become pregnant. and anyways, they’re just like men. now we know that’s not the case,” bérard says.
“i think the idea was noble. they wanted to protect pregnant women and the unborn child. but by doing this, they’re actually putting them at increased risk.” now there are initiatives, like pregtrial, for pregnant and lactating women to be included in randomized controlled trials before a drug is approved.
in many ways, pregnant women are very similar to their peers who are not pregnant in terms of the types of conditions they have and treatments, but in pregnancy, there’s always a worry about the child.
risks for women who are undertreated
“so at the end of the day, nobody is taking care appropriately because many times you undertreat mothers just because you’re afraid,” bérard says. her work with clinicians, patients and policymakers also aims to oblige the pharma company, after a drug’s release, to establish a registry or conduct an observational study to follow pregnant women and also children who use the medication to make sure that they continue to be safe and effective.
while science moves drug development forward, published scientific papers themselves are not geared for the general public, so how do you translate important findings about drug safety in pregnancy? the hub, which recently marked its first year, is designed to serve that purpose, again addressing the knowledge gap. its free resources include fact sheets on medications and medical conditions, videos, podcasts and infographics.
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as well, hub partners engage people through social media and community focus groups, especially with black communities, newcomers and inuit from nunavut, to hear their perspectives and work to deliver information they’re looking for. “we have a focus group right before christmas that’s going to be in arabic because we want them to be included and express themselves,” she adds.
why is this outreach important?
it’s a loaded question because there are so many reasons. health equity is a leading driver for the hub as it looks to gather feedback from diverse populations and then include them in new research endeavours that address unmet needs.
dr. anick bérard notes that all these medications were approved by health canada, but they were approved to be sold and prescribed with zero data on pregnant women.
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“we have an annual meeting, and we basically put everyone in a bag, and we shake it and we talk to each other and we have decision makers, health canada, we have the sogc (society of obstetricians and gynaecologists of canada) and because of that we cover such a wide range from research all the way to policy to guidelines to application. most importantly is that we identify because we talk with people who have conditions that need to be treated,” she explains.
“now i would not do one piece of research without a person with lived experience, that’s where it starts.”
she cites the example of pre-eclampsia, which is hypertension in pregnancy. the highest prevalence of pre-eclampsia is in black pregnant women. low-dose aspirin, a simple remedy, has been shown to be highly effective, and in this case, randomized controlled trials with pregnant women were conducted for testing.
“but in the black community, taking medication is not culturally acceptable,” she notes. a black woman who participated in one of the hub focus groups explained that she developed pre-eclampsia during her first pregnancy and had a difficult pregnancy. when she became pregnant again, she took the low-dose aspirin as advised by her doctor. however, she didn’t have pre-eclampsia and had a beautiful baby. for her third pregnancy, her doctor reminded her to take the low-dose aspirin because she’s at risk of pre-eclampsia.
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as bérard recalls, “then she thought to herself, in my community, people don’t like to take medication. i do not trust healthcare providers. and then she said, ‘well, the second pregnancy was good,’ so she didn’t take the low-dose aspirin, and she had a terrible pregnancy and terrible delivery.”
her baby was born preterm and spent time in the neonatal intensive care unit.
“she was a wreck because her baby was not doing well.”
canada, with partners like the hub, is moving toward screening for those at higher risk of pre-eclampsia, she notes.
research has shown that black women are over-represented in mortality after childbirth. they are also at increased risk of several conditions that can quickly worsen without timely assessment and adequate care, including preeclampsia and gestational diabetes.
consequences of unmanaged type 2 diabetes during pregnancy
another condition on the radar is type 2 diabetes in pregnancy, as rates of obesity, a contributing factor, are rising. because symptoms of type 2 diabetes can go overlooked, many women don’t know that they have it. many women also don’t know they have hypertension, another silent condition.
“prenatal care is an excuse, i’m going to say, to diagnose chronic hypertension and chronic diabetes many times during the first prenatal visit. and at that point in time, well, you have to act soon.”
while metformin and glp-1 drugs like ozempic are typically prescribed for type 2 diabetes, physicians feel more comfortable prescribing insulin (or a combination of insulin and metformin) because, again, there is a lack of data on metformin and glp-1 drugs for type 2 diabetes or obesity, she notes. the hub is currently studying glp-1 impacts.
“but if you’re used to taking medication orally, switching to an injectable is very difficult. and the observance of the treatment is not very good,” she says of administering insulin injections. however, the fallout of not managing glucose during pregnancy can be lifelong cardiovascular disease that might not happen in the months after pregnancy, but down the road, longer-term. for the baby, untreated type 2 diabetes can lead to premature birth or larger weight babies.
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bérard, who first worked in pharmacology research for the elderly, says the knowledge gap for pregnancy and pharmaceuticals was even more vast in 2000 when she moved into the field. the gains over her 25 years have culminated in the efforts of the healthy pregnancy hub—work she’s clearly passionate about. the focus on research and knowledge dissemination is augmented with the hub’s training arm to guide the next generation of researchers, she says.
“for young researchers, masters, phds and postdoc students, those early career researchers are involved in the hub as well. we not only train them for research, but we train them for knowledge dissemination, which is a skill in itself.”
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