Use of prescription medications with a potential for fetal harm among pregnant women

Susan E. Andrade, University of Massachusetts Medical School
Marsha A. Raebel, Kaiser Permanente Colorado
Abraham N. Morse, University of Massachusetts Medical School
Robert L. Davis, Kaiser Permanente Georgia
K. Arnold Chan, Harvard Medical School
Jonathan A. Finkelstein, Harvard Medical School
Kris K. Fortman, HealthPartners Research Foundation
Heather McPhillips, Center for Health Studies
Douglas W. Roblin, Kaiser Permanente
David H. Smith, Kaiser Permanente
Marianne Ulcickas Yood, Henry Ford Health System
Richard Platt, Harvard Medical School
Jerry H. Gurwitz, University of Massachusetts Medical School

Abstract

PURPOSE: To estimate the prevalence of use of prescription drugs with a potential for fetal harm among pregnant women in the United States.

METHODS: A retrospective study was conducted using the automated databases of eight health maintenance organizations involved in the HMO Research Network Center for Education and Research on Therapeutics (CERT). Women who delivered an infant from January 1996 to December 2000 were identified. The frequency of use of prescription drugs with a potential for fetal harm was based upon the expert review of a clinical teratologist and the U.S. Food and Drug Administration (FDA) risk classification system, assuming a gestational duration of 270 days.

RESULTS: Among the 114 165 women with no documentation of a diagnosis suggesting potential pre-term birth or dispensing of ovulation stimulants in the 270 days before delivery, 1305 (1.1%) received a teratogenic drug during the 270 days before delivery, based upon the expert review of a clinical teratologist. A larger proportion of women received U.S. FDA category D or X drugs (5.8%; N = 6600). However, the general patterns of use were similar, with higher use in early pregnancy compared to later trimesters. The proportion of women dispensed a teratogen during pregnancy was substantially higher among women who received a teratogen in the 90 days before pregnancy compared to women who did not (adjusted RR = 38.9, 95%CI, 33.5, 45.3).

CONCLUSIONS: Our results suggest that further efforts directed at physicians to counsel women or at the women themselves about the potential risks of particular medications appear warranted.