Filling the knowledge gap

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The information needs of women who need to take medications during pregnancy and breastfeeding are not currently being met. A new project aims to change that, writes Danielle Barron.

Over 200 million women will become pregnant each year, of which a significant proportion have a chronic illness or may become ill during pregnancy. Drug use at this time is common: we know that in high-income countries, four out of five pregnant women are prescribed one or more medications in pregnancy, and even more will self-medicate with over-the-counter drugs. It is also estimated that more than half of new mothers take one or more medications in the months after delivery. 

Yet almost all – more than 98% – of available drugs have insufficient pharmacokinetic or safety data to guide dosing in women who are pregnant or breastfeeding. This not only means confusion for women trying to decide if a medication is safe for them and their baby, but that health care providers often lack the evidence they need to counsel breast-feeding women on the potential effects of a drug on mothers or their babies.

A 2019 paper argued that chronic under-investment both in new drug development and in clinical trials of established therapies in pregnancy is the cause of this, and further argued that even when teratogenic (causing birth defects) effects of medications are recognised, communication about risk to women of reproductive age is subpar or inadequate.

Linda Härmark, Head Innovation at Netherlands Pharmacovigilance Centre Lareb points out that clinicalstudies frequently exclude pregnant and lactating women, for fear of harming the infant.

“In general there is very little information about the safety of drugs in these periods because pregnant and breastfeeding women are not included in the clinical trials of drugs. 

She says the hope is that in the post-marketing phase, as a drug is increasingly used, more information on its safety for these uniquely vulnerable populations would become available but she acknowledges that to date this is an area that has been neglected, making it “very difficult” to collect this data.

That’s what the ConcePTION project is trying to tackle. Its overarching aim is to build and test a trustworthy pan-European ecosystem for generating, monitoring, and providing robust and rapid evidence on medication safety in pregnancy and breastfeeding in a collaborative and standardized manner to inform not only drug labels, but women, families, and health care professionals. The IMI-funded project unites an unprecedented 88 organizations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organizations, and teratology networks in a bid to deliver solutions to a decades-long public health issue. 

“We are looking at how we can generate information that is lacking at the moment and how we can make sure this information reaches both pregnant or breastfeeding women and healthcare professionals so they can take this information into account when they are making therapeutic decisions,” Härmark explains.

The goal is to develop new ways of using the data that is already out there. Härmark’s work in pharmacovigilance has already been contributing towards the collation of more and better data. 

“At the Centre where I work, we work in two ways; we have our spontaneous reporting system where people can report adverse events that occur after a drug has been used during pregnancy or lactation, but then you only have the harms and these are very small numbers.

To fill this gap, our centre developed a pregnancy register, in which all pregnant women can participate, and which collects data regarding drug use and eventual outcome of the pregnancy and health of the baby,” she explains.

Härmark adds that another role of the teratology experts in ConcePTION is to interpret the available data, saying this is critical as consensus may be lacking when it comes to the limited research on medicines and pregnancy.

“It is difficult when you have different studies where one might say high risk and one might say low risk.” 

Ensuring pregnant and lactating women have access to this data is a key objective of the ConcePTION project; “we not only want to generate information but we also want to ensure that women and healthcare professionals have access to this information so that they can use it when they make their therapeutic decisions,” Härmark says.

Access to this information varies considerably between countries across the European Union; for example some countries, such as the UK, France and the Netherlands, do have information publicly available, but in other countries, the data is unavailable or almost impossible to access.

“We want to fill this void, by creating a Europe-wide knowledge bank where we provide scientifically robust information about the drug’s use during pregnancy and lactation.”

Pregnant and breastfeeding women are left trying to fill that void by turning to the internet. Social media and online chat rooms contain pages of discussion about drugs in pregnancy but this anecdotal information can be inaccurate at best and downright harmful at worst.

As part of the ConcePTION study, Härmark and her collaborators have been able to determine that information on the safety of different medications during pregnancy and lactation is freely available online but it is of varying quality and can often be conflicting. This makes it especially difficult for pregnant or lactating women to know which sources of information to trust, meaning the delicate risk/balance of taking certain medications at this time can turn into little more than a guessing game. And that’s why another goal of the knowledge bank is to harmonise the existing information, Härmark says, providing a one-stop-shop for good quality information.

So how does this paucity of information impact healthcare for women who are pregnant or breastfeeding? Härmark admits it can often lead to suboptimal treatment.

“This can go both ways – some people might be very afraid to use something, but in many cases it is worse not to use a drug than to use it because often the disease itself can have a more negative impact on the patient, and pregnancy or the baby. [AK1]  It can also be that if we don’t have enough information, then women may mistakenly think it’s safe to use a particular drug or use it in the wrong way and it could be harmful to her or the baby.”

Knowledge is power, she concludes. “Having information makes it possible to give adequate consideration to what the benefits and the risks are compared with not using the drug.”


  • COVID-19
  • Maternal Health