Safety Alerts Saves Lives
Safety Alerts  
Home Privacy About Us Contact Us Change Preferences

January 22, 2000

Accutane-Exposed Pregnancies Continue to Occur and Result in Severe Birth Defects

Atlanta, GA (SafetyAlerts) - The Center for Disease Control and Prevention (CDC) is again warning women of possible birth defects associated when Accutane® is taken just before or during pregnancy.

Accutane is a vitamin A derivative, manufactured by Hoffmann-La Roche of Nutley, N.J., licensed for the treatment of severe acne that has not responded to other treatments. 

Beginning in 1983 there were reports of severe human birth defects associated with the drug.  Subsequently, efforts to prevent Accutane pregnancy exposures and birth defects were undertaken by the manufacturer and FDA.  The latest and most extensive effort aimed at eliminating birth defects, referred to as the "Pregnancy Prevention Program for Women on Accutane" was initiated by the manufacturer in late 1988, although it was not fully implemented until mid-1989.

Despite package warnings and a pregnancy prevention program, Accutane-exposed pregnancies continue to occur.

Back in April of 1988, the FDA had a total of 62 reported birth defects attributed to Accutane. Additional warnings were issued in February of 1998 announcing that the FDA had received reports of depression, psychosis and, rarely, suicidal thoughts and actions in people using Accutane.

Recently, some 14 women who experienced Accutane®-exposed pregnancies were studied to, among other things, determine how this occurred.  Some of the reasons that have caused exposure to the product during pregnancy 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 prior to prescribing Accutane®, prescribing outside the usual doctor-patient relationship, and use of leftover medication.

Physicians should use caution in prescribing Accutane® to women of childbearing potential.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.



The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.