Survey of Accutane Use in Women


  • To determine the rate of pregnancy among women of childbearing age who use Accutane (isotretinoin).
  • To assess physician and patient compliance with procedures designed to prevent pregnancy.


To minimize the risk of pregnancy during Accutane exposure, the manufacturer and FDA instituted a “Pregnancy Prevention Program” (PPP) directed at both the prescriber and women who are treated with the drug. To assess the effectiveness of this program, the Survey sought to enroll all women of childbearing age to whom Accutane was prescribed. Enrollment, which was voluntary, was achieved through a form made available to patients by their physician at the time of Accutane prescription; the form was also included in each medication package, a novel enrollment approach developed by the Survey. Upon enrollment, women were randomized to follow-up either with contacts during and following treatment or with contact only after completion of treatment. Information was collected on the women’s understanding of the teratogenic risks of Accutane, their history of acne therapy, their pregnancy prevention practices, and the occurrence (and outcomes) of pregnancies during Accutane exposure. On-going analyses seek to identify risk factors for pregnancy.


The Survey enrolled 591,933 women. Compliance with most measures of the PPP was high. The pregnancy rate was 2.5 per 1,000 140-day courses of isotretinoin based on completed follow-up of 447,679 women who used isotretinoin for less than one year. This rate varied from 4.0 to 3.0 between 1989 and 1992, then decreased; from 1993 through 1997, it ranged between 2.4 and 2.8, and in the 1998 through 2002 cohorts, it further declined to 2.1, 2.2, 1.6, 1.8, and 1.1, respectively.

Investigators and Study Staff

Allen A. Mitchell, M.D., Principal Investigator
Carla M. Van Bennekom, R.N., M.P.H., Co-Investigator

Study Details

Sources of Funding:

Hoffmann-La Roche, Inc.

Study Period:

1989 to 2003


  • Mitchell AA, Van Bennekom CM. Response to FDA letter on Accutane Survey [letter to the editor]. J Am Acad Dermatol 2003;49:1201-2.
  • Chambers CD, Jones KL, Lammer EJ, Van Bennekom CM, Mitchell AA. Accutane-exposed pregnancies–California, 1999. MMWR 2000;49:28-31.
  • Rao RS, Glynn RJ, Werler MM, Van Bennekom CM, Mitchell AA. Comparison of alternative survey methods for sensitive self-reported behaviours in a follow-up study of isotretinoin. J Epidemiol Biostat 2000;5:133-6.
  • Rao RS, Glickman ME, Glynn RJ. Using multiple imputation for the analysis of a multi-wave survey with nonresponse. In: Proceedings of the section on epidemiology. Alexandria, VA: American Statistical Association, 1998:140-5.
  • Mitchell AA, Van Bennekom C, Louik C. A pregnancy-prevention program in women of childbearing age receiving isotretinoin. N Engl J Med 1995;333:101-6.