Isotretinoin capsules
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Isotretinoin capsules should not be used in pregnancy as they can cause miscarriage and birth defects. If you are taking isotretinoin and could become pregnant, you should be enrolled in a Pregnancy Prevention Programme.
What is it?
Isotretinoin (Roaccutane®) is a medicine used to treat severe acne.
Benefits
What are the benefits of taking isotretinoin in pregnancy?
Isotretinoin should not be used during pregnancy. Females of childbearing potential who take isotretinoin should be enrolled on a Pregnancy Prevention Programme that involves:
• using reliable contraception (preferably 2 forms)
• having a negative pregnancy test one month before starting treatment
• having a negative pregnancy test before starting a repeat prescription
• having a negative pregnancy test one month after stopping treatment
Risks
Are there any risks of taking isotretinoin during pregnancy?
Yes, isotretinoin can cause miscarriage and birth defects. Many women who become pregnant while using isotretinoin choose to terminate their pregnancies because of these risks.
For women who continue their pregnancies, studies show that around 3 out of every 10 might have a miscarriage. One study has also shown that pregnant women who take isotretinoin tablets may have an increased risk of ectopic pregnancy.
It is thought that up to 1 in every 5 babies born to women who took isotretinoin during early pregnancy will have one or more of the following 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 use of isotretinoin for less than one week has been linked to birth defects.
Isotretinoin is cleared slowly from the body, and it is important to wait at least a month after stopping treatment before becoming pregnant.
Alternatives
Are there any alternatives to taking isotretinoin in pregnancy?
Yes. Creams and gels can also be used to treat acne, and although they might not work as well as isotretinoin tablets, they will not harm your baby.
No treatment
What if I prefer not to take medicines to treat acne during pregnancy?
It is likely to be safe to stop acne treatment during pregnancy. Speak to your doctor or specialist if you need further advice.
Will my baby need extra monitoring?
Women in the UK will be offered a very detailed scan at around 20 weeks of pregnancy as part of routine antenatal care. Taking isotretinoin in early pregnancy might mean that this scan is offered slightly earlier.
Are there any risks to my baby if the father has taken isotretinoin?
We do not expect any increased risk to your baby if the father takes isotretinoin.
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.