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An international study led by has found that the use of antipsychotic drugs during pregnancy is not linked to childhood neurodevelopmental disorders or learning difficulties.

Antipsychotics聽鈥� designed to treat schizophrenia and bipolar disorder聽鈥� can help reduce psychotic symptoms such as hallucinations or delusions, but they are also widely used for other mental health conditions and developmental disorders like anxiety, depression, autism spectrum disorder and insomnia.

Many women and pregnant people using these medications may feel concerned about the potential risks they pose to their unborn baby.

The UNSW study tracked the long-term risk of a child developing neurodevelopmental disorders and learning difficulties after being exposed to antipsychotics in the womb.

The study found that there is no increased risk when taking the medication during pregnancy, not only for the specific neurodevelopmental disorders that were looked at, but also ADHD and autism as shown in the team鈥檚 previous studies, said Dr Claudia Bruno, lead author and pharmacoepidemiologist based at UNSW鈥檚 School of Population Health.

鈥淭he findings are really reassuring for both women managing these psychiatric conditions during pregnancy and their providers,鈥� Bruno said.

Harnessing the power of data

This research is the most comprehensive study on antipsychotics and neurodevelopmental outcomes to date: it pulls together nationwide data from Denmark, Finland, Iceland, Norway and Sweden into a large sample size of 213,302 children born to mothers with a diagnosed psychiatric condition, 5.5% (11,626) of which were prenatally exposed to antipsychotics.聽

These five Nordic countries all have similar health and education systems and keep detailed data on birth records, filled prescriptions and diagnoses from inpatient and outpatient specialist care, as well as antenatal care. The researchers teamed these data with results from the children鈥檚 first standardised national school test (similar to Australia鈥檚 NAPLAN tests), which happens between the ages of 8鈥�10.

鈥淚t鈥檚 reassuring that everything points to the same 鈥榥o major indication鈥� of increased risks overall,鈥� said Scientia Associate Professor Helga Zoega, senior author of the study and pharmacoepidemiologist, also based at UNSW鈥檚 School of Population Health.

鈥淭he study builds on our team鈥檚 previous work that looked at birth outcomes, including serious congenital malformations, where we鈥檝e seen similar null results.聽

鈥淚 think it鈥檚 important to get excited about null results because this is essential information for the management of serious mental health conditions in pregnancy. It鈥檚 equally important as finding an increased risk of outcomes.鈥�

Medication safety in pregnancy

While this study is part of a growing body of research about medication safety in pregnancy, there鈥檚 still a lot left in this field to discover, Zoega said.

鈥淭his is a hugely understudied area,鈥� she said. 鈥淯nfortunately, we know way too little about medication safety during pregnancy.鈥�

One of the reasons so little is known about medicines and pregnancy is that it鈥檚 simply not feasible 鈥� or in many cases, ethical 鈥� to conduct randomised clinical trials on pregnant women. The potential risks of testing or withholding treatment to the unborn child and mother or pregnant person is often too great.

That鈥檚 where harnessing big data can step in聽鈥� although the research isn鈥檛 as simple as looking at the raw data alone.聽

For example, women treated with antipsychotics during pregnancy were more likely to smoke, have higher BMIs and lower education levels, to be older (35 years or more) and to use other medications during pregnancy compared to women who didn鈥檛 take antipsychotics during pregnancy 鈥� all of which are risk factors that can potentially impact birth outcomes.聽

These circumstances 鈥� called 鈥榗onfounding factors鈥� 鈥� are accounted for in observational research using careful study design and complex adjusted risk models to make sure the results show the impact of the medication alone.聽

鈥淭hese types of studies are methodologically tricky, and can take a long time to do,鈥� Zoega said. 鈥淭his study has been in the making for almost 10 years now.

鈥淲e already know these women are dealing with psychiatric conditions, and by genetic default, their children would be more likely to have psychiatric or neurodevelopmental outcomes. But we鈥檙e focused on the risks and benefits of the medication treatment in pregnancy, so we use methods to make the comparison groups as similar as possible.鈥�

The researchers also strengthened their findings by slicing up the data to take a closer look at whether individual medications, trimesters of exposure, and siblings carried higher risk levels.

While one antipsychotic, chlorpromazine, showed potential increased links to language and speech delays, these findings were based on small sample sizes of 8鈥�15 children, so more research is needed to investigate this potential link.

Other than this anomaly, the results supported the finding that there was little to no increased risk of children prenatally exposed to antipsychotics developing neurodevelopmental disorders or learning difficulties.

Looking ahead

Bruno is currently involved in two related studies on prenatal medication use and pregnancy outcomes. One explores if there is a relationship between the use of antiseizure medications during pregnancy and child school performance, and the other examines whether ADHD medication use and discontinuation during pregnancy has an impact on child health outcomes.

But she sees many avenues for future research to build on this work, including harnessing more Australian big health data.

Zoega co-leads an international research collaboration called International Pregnancy Drug Safety Study (InPreSS), which investigates the safety of medication in pregnancy. She said there was plenty to do in this space.聽

鈥淎ntipsychotics are only one class of medications, and we already know that up to 80% of women use at least one prescription medicine during pregnancy. Most often, there鈥檚 little or no guidance on safety.

鈥淭here are so many unanswered questions that there鈥檚 enough for a lifetime of research.鈥�

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