Sodium cromoglicate

Date: January 2020, Version 3

What is it?

Sodium cromoglicate (Optrex Hayfever Relief®, Allercom®, Aspire Allergy Relief®, Catacrom®, Murine Hayfever Relief®, Nalcrom®, Opticrom®) is most often used to treat eye irritation caused by allergy and is given in the form of eye drops. It is occasionally given in tablet form to treat food allergies, or via an inhaler to treat asthma.
When deciding whether to use sodium cromoglicate (or any medicine) during pregnancy it is important to weigh up the potential benefits to your health and wellbeing against any possible risks to you or your baby, some of which may depend on how many weeks pregnant you are. Your doctor or specialist will be able to help you make decisions about your treatment

What if I have already used sodium cromoglicate during pregnancy?

If you are taking any medicines while pregnant you can discuss this with your doctor. You can then decide together whether ongoing treatment is appropriate, and, if so, your doctor will ensure that you are taking the most effective dose. Medicines given in the form of eye drops are generally not absorbed into the body in large amounts and most are therefore unlikely to cause problems in the unborn baby. Even when taken in the form of a tablet or an inhaler, sodium cromoglicate enters the mother’s bloodstream in low amounts that are thought unlikely to pose a risk.

Can using sodium cromoglicate in pregnancy cause birth defects in the baby?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

Around 650 women using sodium cromoglicate in early pregnancy have been studied with no concerns raised of a link with birth defects in the baby. Although ongoing research is ideally required to confirm this, the fact that sodium cromoglicate enters the mother’s body in such small amounts also provides further reassurance.

Can using sodium cromoglicate in pregnancy cause miscarriage, stillbirth, preterm birth, or my baby to be small at birth (low birth weight)?

No studies have specifically assessed the likelihood of these pregnancy outcomes in women using sodium cromoglicate in pregnancy. Although ongoing research is ideally required to rule out any problems, sodium cromoglicate is absorbed into the mother’s body in low amounts that are thought unlikely to pose a risk to an unborn baby.

Can using sodium cromoglicate in pregnancy cause learning and behavioural problems in the child?

A baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have assessed the learning and behaviour of children born to women using sodium cromoglicate. However, no adverse effects would be expected due to the very small amount of the medicine that might reach a baby in the womb.

Will my baby need extra monitoring?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Using sodium cromoglicate in pregnancy would not normally require extra monitoring of your baby.

Are there any risks to my baby if the father has used sodium cromoglicate?

We would not expect any increased risk to your baby if the father used sodium cromoglicate before or around the time you became pregnant.

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.