Sodium cromoglicate

(Date: January 2020. Version: 3)

This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by the UK Health Security Agency (UKHSA) on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.

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.

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General information 

Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks.  They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.

Medicines use in pregnancy

Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby.  There are, however, some medicines that can harm a baby’s normal development.  How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.

If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.

When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.   

Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.

Disclaimer: This information is not intended to replace the individual care and advice of your health care provider. New information is continually becoming available. Whilst every effort will be made to ensure that this information is accurate and up to date at the time of publication, we cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes following decisions made on the basis of this information. We strongly advise that printouts should NOT be kept for any length of time, or for “future reference” as they can rapidly become out of date.

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