Acne Home > Accutane and Pregnancy

There are strict regulations regarding the use of Accutane (isotretinoin) by women of childbearing age. The FDA has classified Accutane as a pregnancy Category X medication, meaning that serious problems could occur if this medication is used during pregnancy. Accutane has been shown to cause miscarriages and severe birth defects. Due to these potential risks, women of childbearing potential must follow strict rules when taking Accutane.

An Overview of Accutane and Pregnancy

Accutane® (isotretinoin) is a prescription acne medication that is extremely dangerous for use during pregnancy. It is likely to cause miscarriages, birth defects, and other problems. Women who are pregnant or who could become pregnant must not take Accutane.

Accutane and Pregnancy Category X

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.
If taken during pregnancy, Accutane has a high risk for causing miscarriages and birth defects. The birth defects are usually quite severe and often result in death of the infant shortly after birth. In order to help prevent pregnant women from taking the drug, the FDA, the manufacturers of Accutane, and the manufacturers of generic Accutane have developed the iPLEDGE program. The program became necessary when strict warnings and consent forms did not appear to be sufficient to prevent women from getting pregnant while taking this medication.
The greatest risk for problems occurs if Accutane is taken anytime within two to five weeks after conception. This means that by the time a woman discovers she is pregnant, the damage is usually already done.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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