Isotretinoin skin gel

(Date of issue: 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 is it?

Isotretinoin skin gel (Isotrex®, Isotrexin®) contains a form of Vitamin A and is used to treat acne.

Can I use isotretinoin skin gel in pregnancy?

In most situations the use of isotretinoin skin gel during pregnancy is unlikely to cause harm to an unborn baby. Whereas Isotretinoin taken in tablet form during pregnancy can cause severe birth defects and learning difficulties in the baby, only a very small amount of isotretinoin from gel applied to the skin is likely to reach a baby in the womb. 

If, however, you have used very large amounts of gel for a long period of time or you have a skin condition that results in isotretinoin being more easily absorbed, potentially harmful levels of isotretinoin may accumulate in your bloodstream.

For this reason, and because there is not yet enough evidence to confirm that isotretinoin gel is completely safe, its use cannot be recommended during pregnancy. If you are using isotretinoin gel it is advisable to use a reliable form of contraception and to speak to your doctor before planning a pregnancy.

What if I have already used isotretinoin skin gel during pregnancy?

The available scientific evidence does not suggest that using isotretinoin skin gel during pregnancy is harmful to an unborn baby. However, if you have used isotretinoin skin gel whilst pregnant, you should speak to your doctor.

Can using isotretinoin gel in pregnancy cause my baby to be born with birth defects?

A recent study showed that mothers who applied isotretinoin and related skin treatments to their skin during early pregnancy were no more likely to have a baby with a birth defect than mothers who did not use isotretinoin. Although there are some reports of babies with birth defects being born to women who applied isotretinoin gel during pregnancy, it is unlikely that the abnormalities in many of these babies were caused by the gel. In general, isotretinoin applied to skin is not well absorbed into the bloodstream and very little is expected to reach the baby in the womb.

Can using isotretinoin gel in pregnancy cause miscarriages?

One study has shown that women who use isotretinoin gel or similar types of skin creams during early pregnancy do not have a higher chance of having a miscarriage. Very little isotretinoin is absorbed from the gel form, therefore we would not expect that use of isotretinoin gel during pregnancy would increase a woman’s chance of having a miscarriage.

Can using isotretinoin gel in pregnancy cause other problems in pregnancy, or for my baby?

No increased risk of giving birth prematurely (before 37 weeks of pregnancy), of having a baby weighing less than 2500g at birth, or of stillbirth, was shown in one study of women who used isotretinoin gel and related skin treatments during early pregnancy.

Can using isotretinoin gel in pregnancy cause behavioural and learning problems in the child?

No studies have been carried out which look at whether there is an increased risk of behavioural and learning problems in children whose mothers used isotretinoin gel while they were in the womb. Very little isotretinoin is absorbed from the gel form, therefore no effect on the baby’s brain development in the womb would be expected.

Will my baby need extra monitoring during pregnancy?

Use of isotretinoin gel during pregnancy is not expected to cause any problems that would require extra monitoring of your baby before or after birth.

Are there any risks to my baby if the father has used isotretinoin gel?

We would not expect any increased risk to your baby if the father used isotretinoin gel 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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