Oral isotretinoin is a potent teratogen, meaning that it is well known to cause birth defects in children whose mothers get pregnant while taking oral isotretinoin or within 1 month after stopping isotretinoin. For this reason, any woman of child-bearing potential who plans on taking isotretinoin must have a negative pregnancy test before starting treatment and for at least 1 month after therapy. Adequate contraception is essential, and the importance of this cannot be overstated before and during treatment as well as for 6 weeks after discontinuing treatment.
Therapy should start on the first, second, or third day of the menstrual period once the results of two negative pregnancy tests have been obtained.
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