January 22, 2000Accutane-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
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.