Safety first: What’s best for both mother and baby when it comes to medication in pregnancy

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Mr Fergal O’Shaughnessy is a pharmacist and PhD candidate at the Rotunda Hospital, Dublin and SPHeRE programme at the Division of Population Health Sciences, Royal College of Surgeons in Ireland. He spoke to Danielle Barron on the need for better information on the safety of medicine use during pregnancy and breastfeeding

In your role, you meet many women who are pregnant/new mothers/breastfeeding and are taking medication. As a frontline HCP, how do you think women feel about taking medication at these times? Are they reluctant, even though the medication is prescribed for valid reasons?

It is very common for women to take medicine at some point during pregnancy or when breastfeeding. Many of the women we care for take medication to treat a pre-existing medical condition, or to treat a condition or symptom which arises during, or due to pregnancy or breastfeeding. It is natural for pregnant or breastfeeding women to think about the potential impact of this medication on their baby.

However, there is often limited information about the safety of medicines in pregnancy and breastfeeding. Patient information leaflets may be difficult to understand, or may recommend that the drug should not be used during pregnancy and breastfeeding, even though it has been prescribed. Some women also report reading conflicting information on the internet or receiving different information from different healthcare professionals. As you can imagine this is confusing and can be a source of anxiety for mothers-to-be or new mothers.

Because of this, some women are reluctant to take medication during pregnancy and breastfeeding. In practice, we meet women who stop taking their medication when they find out they are pregnant. But this might not always be best for mum and baby. We know that there are some conditions, which, if left untreated or if poorly treated, can cause harm to the baby. In some cases, medicines are necessary to ensure that mum and baby remain healthy and well, and taking a medication may be the safer option.

But deciding whether to take a medication during pregnancy or when breastfeeding is not always easy or straightforward. It is a very individualised decision and depends on many factors; for example what medical condition or disease being treated, the severity of the condition and the medication in question. Some women may continue on the same medication, others may be changed to a different medication or medication may be stopped in others. This decision is best made by an individual woman in consultation with her healthcare providers. 

We recommend that if you are taking a medicine and you think you might be pregnant or you are pregnant, talk to a healthcare professional before making any changes. This may be your GP, pharmacist, midwife or hospital doctor. By doing this your healthcare professional can provide accurate information, talk you through your options and support you in your decision.

As a pharmacist, do you find that information is often unclear when it comes to taking medication at these times? For a professional, as well as the person who is prescribed the medication?

Absolutely; finding reliable and accurate information about the safety of medicines in pregnancy and breastfeeding can be difficult and sometimes overwhelming for both women and healthcare professionals.

There are many medicines which have good evidence to suggest they are safe to use in pregnancy or breastfeeding. However, there are also many medicines where very little research has been carried out on their use in pregnant or breastfeeding women, or there isn’t enough information available to give a definite answer. At other times, there may be information available, but the results are mixed or conflicting.

Where information is limited or conflicting, the unknown or potential risks of taking a medication must be weighed up with the potential risks of an untreated or under-treated medical condition. In these cases it is essential to have accurate and balanced information which includes the potential risks of taking medication, but also the potential risks of not taking the medication. Health professionals can support women and their families by providing all available information in a way that is easy to understand.

However, finding and communicating information about the use of medicines in pregnancy and breastfeeding can be a challenge for healthcare professionals, especially in non-specialist settings such as a GP clinic or a community pharmacy. Many routinely available information sources simply do not provide enough information to allow women and healthcare professionals to make an informed decision. This can at times lead to different healthcare professionals providing different information, which, again, can lead to confusion or worry in pregnant or breastfeeding women.

Part of my role in the Irish Medicines in Pregnancy Service at the Rotunda Hospital, is to improve this by providing evidence based information to healthcare professionals. There are a number of other specialist centres, connected through the European Network of Teratology Information Services (ENTIS), which can provide information and counselling on the use of medicines in pregnancy and breastfeeding.

Is this the same for prescribed drugs as well as over the counter medication?

It is important to note that just because a medicine is available without a prescription doesn’t mean it’s safe to take during pregnancy or when breastfeeding. Some over the counter medicines are suitable for use in pregnancy and breastfeeding, however not all are. For example, paracetamol can be used in pregnancy and breastfeeding; however anti-inflammatory medication such as Ibuprofen should be avoided at certain times during pregnancy.  In other situations it is necessary to consider whether a medication is needed or whether another treatment approach may be effective; for example, some women may manage constipation by increasing fluid intake or making changes to their diet instead of taking medicines for constipation.

It is always best to check with your pharmacist or doctor before taking any over the counter medication.

How do you feel better information on the safety of medication use when pregnant/breastfeeding could be provided/accessed?

I suppose the first thing that is needed is additional research on the safety of medicines in pregnancy and breastfeeding. To achieve this, we need more research and international collaboration on medicines use in pregnancy and breastfeeding. Second, it is necessary to make this information available to those who need it. Information should be objective, evidence-based and accurate. 

Importantly this information also needs to be easy to understand and accessible to all, including women, their families and healthcare professionals in specialist and non-specialist settings.  

Fortunately, this seems to be changing, with increased awareness of this issue and various international projects in the area of medicines use in pregnancy and breastfeeding. I am working as part of IMI ConcePTION, a European-wide project, which intends to build an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding. A key component of IMI ConcePTION is the creation of a European ‘Knowledge Bank’, an online resource where women and healthcare professionals can access evidence-based information on the use of medicines in pregnancy and breastfeeding. We hope that this will support safe and effective medicines use in the future.


  • Maternal Care
  • Maternal Health
  • Medication In Pregnancy