Isotretinoin tablets

(Date: November 2013. Version: 2.1)

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 Public Health England 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 are they?

Isotretinoin tablets (Roaccutane®) contain a form of vitamin A that is used in the treatment of severe acne.

Is it safe to take isotretinoin tablets during pregnancy?

No: Isotretinoin tablets must not be taken during pregnancy as they can cause severe birth defects and learning difficulties in the baby. There is no known safe dose of isotretinoin.

Women and girls who take isotretinoin tablets should be in a worldwide ‘pregnancy prevention programme’ (PPP). This means:

• agreeing to use reliable contraception (preferably 2 forms) 
• having a negative pregnancy test one month before starting treatment
• having a negative pregnancy test before you start taking a repeat prescription
• having a negative pregnancy test one month after stopping treatment

It is advisable to first start taking isotretinoin tablets on day 2 or 3 of your period as you are unlikely to be pregnant if you are menstruating. Isotretinoin stays in the body for some time after you stop taking it so it is important to avoid getting pregnant for at least one month after the last dose.

What if I have already taken isotretinoin during pregnancy?

If you are pregnant or think you may be pregnant, you should stop taking your isotretinoin tablets until you have spoken to your doctor or another health care provider. It is important that you let them know as soon as possible that you may be pregnant. They will then be able to advise you what you need to do next and make sure that you are aware of the choices available to you.

What is the chance that taking isotretinoin tablets in pregnancy will cause a miscarriage?

It is thought that around 3 to 4 out of every 10 women who take isotretinoin in early pregnancy and who choose not to terminate their pregnancies will miscarry. The risk of miscarriage is therefore about double that of women in the general population. Studies from when isotretinoin tablets were first available found that around 6 out of every 10 women who took isotretinoin tablets in early pregnancy went on to have a miscarriage. The lower miscarriage rates seen today are probably because many women who become pregnant whilst taking isotretinoin tablets now choose to terminate the pregnancy. 

One study has also shown that pregnant women who take isotretinoin tablets may have an increased risk of ectopic pregnancy.

What is the chance that taking isotretinoin tablets in pregnancy will cause birth defects in my baby?

It is thought that up to 1 in 3 women who take isotretinoin during the first 12 weeks of pregnancy will have a baby with one or more of the following structural birth defects or developmental problems:

• abnormally developed brain, eye or ear
• unusual facial features
• cleft palate
• heart defects
• abnormally formed kidney, thymus or parathyroid gland
• learning difficulties

Women who take isotretinoin tablets between weeks 4 and 10 of pregnancy (counting the first day of your last period as day 1 of pregnancy) are thought to have the highest risk of having a baby with structural birth defects because this is the stage of pregnancy when most of a baby’s development occurs. However, there is also evidence of an increased risk of birth defects in babies of women who take isotretinoin during the first four weeks of pregnancy (before their first missed period). Because isotretinoin is cleared slowly from the body it is important to wait at least a full month after stopping treatment before becoming pregnant.

What is the chance that taking isotretinoin tablets in pregnancy will cause learning problems in my child?

Isotretinoin tablets should not be taken at any stage of pregnancy because a baby’s brain continues to develop right up to the end of pregnancy.

Isotretinoin taken during pregnancy can cause damage to a baby’s developing brain that cannot be seen on an ultrasound scan but can lead to problems with learning. It is thought that about half of all children whose mothers took isotretinoin in pregnancy have some form of learning difficulty. These learning problems can range from mild to very severe and have been seen both in children with structural birth defects caused by isotretinoin (listed above) and those who have no structural abnormalities.

Will my baby need extra monitoring during pregnancy?

Women who have taken isotretinoin tablets in the month before or during the first 12 weeks of pregnancy and who decide to continue with their pregnancy should be offered a detailed ultrasound scan to look for birth defects. It is important to understand that scans are not able to pick up all birth defects and cannot predict whether a baby will have problems with learning.

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

We would not expect any increased risk to your baby if the father took isotretinoin tablets before or around the time you became pregnant.

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.

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.

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