Thalidomide

(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

Thalidomide should never be used in pregnancy as it causes serious birth defects in the baby.

What is it?

Thalidomide was introduced in the 1950s to treat sleeping problems and morning sickness. It was withdrawn in the early 1960s as it causes severe birth defects if taken during early pregnancy. However, thalidomide is now being used to treat multiple myeloma (a cancer of the blood that most commonly affects older people) and in some developing countries to treat leprosy.

Is it safe to take thalidomide in pregnancy?

No. Thalidomide use in early pregnancy, particularly around 5-7 weeks after the last period, can cause severe birth defects in the baby.

Women and girls who need to take thalidomide 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 thalidomide treatment and that you understand these risks.

Because thalidomide 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 thalidomide during pregnancy?

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

What problems are caused by taking thalidomide in pregnancy?

A large number of different birth defects have been reported in children of women who took thalidomide in pregnancy. Abnormalities of the hands and arms are most commonly seen and include a very specific abnormality termed phocomelia (where the hands are attached close to the body and the arms are absent or under-developed).

The following birth defects have also been linked to thalidomide:

  • Phocomelia of the legs/feet
  • Missing thumbs, or thumbs with an extra bone
  • Club feet
  • Extra toes
  • Reduced or missing ears and deafness
  • Paralysis of facial nerves
  • Abnormally small eyes and other eye malformations
  • Heart defects
  • Defects of the internal organs, including kidneys, brain, digestive and reproductive systems (it is not certain whether all of these birth defects were caused by thalidomide)

Some children exposed to thalidomide have one of these birth defects while some have several. The type and number of birth defects relates to the exact stage of pregnancy when thalidomide was taken and how many times it was used, although birth defects have been reported following a single dose.

Thalidomide use in pregnancy has also been linked to miscarriage and stillbirth.

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 thalidomide 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 thalidomide?

When a man takes thalidomide, small amounts enter his semen. Men taking thalidomide are therefore advised to use condoms during sexual contact with pregnant women or women of childbearing potential because of the possibility that thalidomide 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.

   

www.medicinesinpregnancy.org

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.