Alitretinoin Douglas Use In Pregnancy & Lactation

Pregnancy, breast-feeding and fertility: Pregnancy and prevention programme: Women who are pregnant must not take Alitretinoin: This medicine can seriously harm an unborn baby (the medicine is said to be 'teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Alitretinoin is taken only for a short time during pregnancy.
The patient must not take Alitretinoin if she is pregnant or if the patient thinks she might be pregnant.
The patient must not take Alitretinoin if she is breastfeeding. The medicine is likely to pass into the milk and may harm the baby.
The patient must not take Alitretinoin if she could get pregnant during treatment.
The patient must not get pregnant for one month after stopping this treatment because some medicine may still be left in the body.
Women who could get pregnant are prescribed Alitretinoin under strict rules. This is because of the risk of serious harm to the unborn baby: These are the rules: The doctor must explain the risk of harm to the unborn baby - the patient must understand why she must not get pregnant and what she needs to do to prevent getting pregnant.
The patient must have talked about contraception (birth control) with a doctor. The doctor will give information on how not to get pregnant. The doctor may send a specialist for contraception advice.
Before starting the treatment, the doctor will ask the patient to take a pregnancy test. The test must show that the patient is not pregnant when starting treatment with Alitretinoin.
Women must use effective contraception before, during and after taking Alitretinoin: The patient must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with a doctor which methods would be suitable for the patient.
The patient must use contraception for a month before taking Alitretinoin, during treatment and for a month afterwards.
The patient must use contraception even if she does not have periods or she is not sexually active (unless the doctor decides this is not necessary).
Women must agree to pregnancy testing before, during and after taking Alitretinoin: The patient must agree to regular follow-up visits, ideally every month.
The patient must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in the body, 1 month after stopping Alitretinoin (unless the doctor decides it is not necessary in this case).
The patient must agree to extra pregnancy tests if the doctor asks her.
The patient must not get pregnant during treatment or for a month afterwards because some medicine may still be left in the body.
The doctor will discuss all these points with the patient, using a checklist and will ask the patient (or a parent/guardian) to sign it. This form confirms that the patient had been told about the risks and that the patient will follow the rules previously mentioned.
If the patient gets pregnant while taking Alitretinoin, stop taking the medicine straight away, and contact a doctor. The doctor may send the patient to a specialist for advice.
Also, if the patient becomes pregnant within one month after she stopped taking Alitretinoin, the patient should contact a doctor. The doctor may send the patient to a specialist for advice.