Isotretinoin tablets

Date: May 2018, Version 3

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 and arrange to speak 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 out of every 10 women who take isotretinoin in early pregnancy and who choose not to terminate their pregnancies may miscarry. 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 every 5 women who take isotretinoin during the first 12 weeks of pregnancy and who choose to continue their pregnancies 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

There is no known ‘safe’ period for isotretinoin exposure in pregnancy, and brief exposures of less than one week have been observed to cause birth defects. Because isotretinoin is cleared slowly from the body it is important to wait at least a full month after stopping treatment before becoming pregnant.

Can taking isotretinoin in pregnancy cause stillbirth, preterm birth, or low birth weight in the baby?

No studies have assessed the chance of these pregnancy outcomes in women taking isotretinoin in pregnancy.

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. 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. The chance of learning and behavioural problems following exposure to isotretinoin in the womb is currently unclear as no studies have been able to accurately assess this.

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 healthcare 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 (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.