Isotretinoin for Acne

Isotretinoin is strictly regulated for use in women by the U.S. Food and Drug Administration (FDA) because of the danger of miscarriage and of serious birth defects in babies whose mothers took the medicine during pregnancy. Doctors may only prescribe these medicines for a female who is not pregnant and who does not intend to become pregnant while taking the medicine. You must also use two methods of birth control and have pregnancy tests on a regular basis while using this medicine.

The FDA has announced that the companies that make isotretinoin have a program to register doctors who prescribe isotretinoin and the people who take it. The program is to ensure that women taking this drug understand the risk of birth defects, take precautions to avoid pregnancy, and know what to do if they become pregnant. If your doctor suggests that you take isotretinoin, you must be registered with iPLEDGE in order to get the drug. You can get more information and register at www.ipledgeprogram.com or by telephone at 1-866-495-0654 (toll-free).

Complete the new medication information form (PDF) (What is a Reference PDF Opens New Window document?) to help you understand this medication.

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