Tretinoin Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: D
Comments:
-This drug is highly teratogenic. If pregnancy occurs during therapy or up to one month after discontinuation, there is a high risk of severe malformation of the fetus particularly if this drug was taken during the first trimester of pregnancy.
-Therapy should only be started in female patients if the patient is suffering from life threatening malignancies and she is informed of the hazard of becoming pregnant during and one month after therapy, she able to comply with the mandatory contraception measures, and any woman of child-bearing potential taking this drug uses effective contraception for 4 weeks before, during and for one month after discontinuation of therapy.
-Microdosed progesterone preparations (minipill) may be an inadequate method of contraception during therapy with this drug.
-Therapy should not begin until the second or third day of the next normal menstrual period.
-A negative pregnancy test result should be obtained within 2 weeks before beginning therapy.
-Pregnancy tests should be performed at monthly intervals during therapy.
This drug is highly embryotoxic and teratogenic in human pregnancy. Increased spontaneous abortions and major human fetal abnormalities related to the use of retinoids have been documented in humans. Defects include abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency. Some of these abnormalities were fatal. Cases of IQ scores less than 85, with or without obvious CNS abnormalities, have also been reported.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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