(Date: September 2022. 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.

Quick read

Pomalidomide should never be used in pregnancy as it may cause serious birth defects in the baby.

What is it?

Pomalidomide is a medicine used to treat a type of cancer of the blood called multiple myeloma and other serious blood disorders. Pomalidomide is a very similar medicine to thalidomide, which is known to cause birth defects in babies exposed in the womb.

Is it safe to take pomalidomide in pregnancy?

No. Pomalidomide has been shown to cause birth defects in animal studies and is structurally similar to thalidomide, which caused miscarriage and severe birth defects in thousands of babies who were exposed in the womb in the 1960s. For more information please see the Bump leaflet on thalidomide.

Although there are no human studies of pomalidomide use in pregnancy, it has to be assumed that pomalidomide may affect a baby in the same way as thalidomide.

Women and girls who need to take pomalidomide and who may become pregnant are therefore required to be in a pregnancy prevention programme (PPP). This usually includes:

  • Agreeing to use reliable contraception, or to abstain from sexual intercourse during treatment and for one month afterwards.
  • Having a negative pregnancy test before starting treatment, and then having repeat pregnancy tests every month during treatment and one month after treatment has stopped.
  • Signing a consent form to say that your doctor has explained the risks to a pregnancy of pomalidomide treatment and that you understand these risks.

 Because pomalidomide stays in the body for some time after you stop taking it, it is important to avoid getting pregnant for at least one month after the last dose.

What if I have already taken pomalidomide during pregnancy?

If you are pregnant or think you may be pregnant and are taking pomalidomide you should urgently contact your doctor or midwife.

Will my baby need extra monitoring during pregnancy?

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.

Women who have taken pomalidomide in the month before pregnancy or during the first trimester and who decide to continue with their pregnancy will be offered more detailed anomaly scans and additional monitoring of the baby’s growth and wellbeing


Are there any risks to my baby if the father has taken pomalidomide?

When a man takes pomalidomide, small amounts enter his semen. Men taking pomalidomide are therefore advised to use condoms during sexual contact with a woman who is or could become pregnant because pomalidomide present in semen may pose a risk to a developing baby.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org

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

Our online reporting system allows women with a current or previous pregnancy to create a digitally secure ‘my bumps record’. You will be asked to enter information about your health, whether or not you take any medicines, and your pregnancy outcome. 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 https://www.medicinesinpregnancy.org/Login/ to register.

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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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