Soriatane and Pregnancy
It is extremely dangerous to use Soriatane (acitretin) if you are expecting. Soriatane is classified as a pregnancy Category X medication, meaning that this drug can cause severe birth defects, such as defects to the heart, face, limbs, and other parts of the body. Women of childbearing potential must use two reliable forms of birth control, starting one month before starting Soriatane and for three years after stopping the medicine.
Soriatane® (acitretin) is a prescription psoriasis medication that is extremely dangerous for use during pregnancy. It is very likely to cause severe birth defects. Women who are pregnant or who might be pregnant must not take Soriatane. Women of childbearing potential must commit to taking extreme precautions to avoid pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in humans who have mistakenly taken the medicine.
Soriatane can cause severe birth defects. The defects may vary widely, affecting the limbs, heart, face, hips, skull, and various other body parts.
Avoiding Pregnancy While Taking Soriatane
It is absolutely essential for women to avoid pregnancy while taking Soriatane and for three years after stopping the medication. Women of childbearing potential must use two reliable forms of birth control, starting one month before starting Soriatane and for three years after stopping it.
Only women who have had a hysterectomy and those who have definitely gone through menopause (as determined by a healthcare provider) are exempt from this requirement. Tubal ligation or not being sexually active does not count as an exemption.
Your healthcare provider will help you determine which two birth control methods are best for your situation. At least one must be a highly effective form (such as a tubal ligation or using combined birth control pills that contain both an estrogen and a progestin). Progestin-only birth control pills are not effective enough and are not recommended.
You must have two negative pregnancy tests before you can start Soriatane. While you take Soriatane, you must have a negative pregnancy test every month. After you stop Soriatane, you must have a negative pregnancy test every three months for three years.
If you ever have sex without using two reliable forms of birth control, if you miss a period, or if you have a positive pregnancy test, immediately contact your healthcare provider.
Alcohol can change Soriatane into a different medication that lasts much longer in the body. If you consume any alcohol while taking Soriatane or within two months of stopping the medication, Soriatane may stay in the body for more than three years. Therefore, you must avoid all alcohol while taking Soriatane and for two months afterward. This includes any form of alcohol, including alcohol in food, beverages, or even medications.
While these precautions might seem excessive, they are in place for very good reasons. No one method of birth control is 100% effective, and by the time you realize you are pregnant, it is usually too late.