Key Findings from Recent Birth Defects and Pediatric Genetics Branch Projects

Accutane^®-Exposed Pregnancies

In March 1999, a CDC scientist interviewed 14 women who had had recent Accutane^®-exposed pregnancies to draw attention to the continued occurrence of these pregnancies and learn more about why these pregnancies happen.

• Accutane^® (isotretinoin) is a prescription drug used to treat severe nodular acne that has not responded to other treatments. It can cause severe birth defects if taken during pregnancy.
    

• Accutane^®-exposed pregnancies continue to occur and result in babies with major birth defects.
   

• Reasons for the exposed pregnancies in this case series included: using Accutane^® unnecessarily, not using any contraception or not using two effective methods of contraception as recommended during Accutane^® treatment, not waiting until three days after menstruation to begin Accutane^®, not performing pregnancy tests before prescribing Accutane^®, prescribing outside the usual doctor-patient relationship, and using leftover medication.
   

• Eight of 14 women in this series were not using any form of contraception when the exposed pregnancy occurred; 13/14 were not using two reliable forms of contraception as recommended.
   

• Physicians should limit use of Accutane^® in women of childbearing potential to those who meet the criteria on the package insert.
   

• Physicians should be knowledgeable about the teratogenic potential of Accutane^® and actively assist their patients in preventing exposure during pregnancy.

Results published in: MMWR 2000;49(2):28-31. (Full Text)

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This page was last updated August 05, 2004