Pregnancy: Tretinoin is teratogenic. Its use is contraindicated in pregnant women and women who might become pregnant during or within one month of the cessation of treatment, unless the benefit of tretinoin treatment outweighs the risk of foetal abnormalities due to the severity of the patient's condition and the urgency of treatment. There is an extremely high risk for any exposed foetus that a deformed infant will result if pregnancy occurs while taking tretinoin, irrespective of the dose or duration of the treatment. Therapy with tretinoin should only be started in female patients of child-bearing age if each of the following conditions is met:
The patient is informed by the physician of the risks concerning pregnancy during and one month after treatment with tretinoin.
The patient is willing to comply with the mandatory contraception measures. It is absolutely essential that every woman of child-bearing potential who is to undergo treatment with tretinoin uses effective contraception during and for one month after discontinuation of treatment with tretinoin.
Pregnancy tests must be performed at monthly intervals during therapy.
In spite of these precautions, should pregnancy occur during treatment with tretinoin or up to one month after its discontinuation, there is a high risk of severe malformation of the foetus, particularly when tretinoin was given during the first trimester of pregnancy.
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