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

Authors

  • Susan E. Andrade ScD,

    Corresponding author
    1. Meyers Primary Care Institute (University of Massachusetts Medical School, the Fallon Foundation, and Fallon Community Health Plan), Worcester, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, USA
    • Meyers Primary Care Institute, 630 Plantation Street, Worcester, MA 01605, USA.
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  • Marsha A. Raebel PharmD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Kaiser Permanente Colorado, Denver, CO, USA
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  • Abraham N. Morse MD,

    1. Meyers Primary Care Institute (University of Massachusetts Medical School, the Fallon Foundation, and Fallon Community Health Plan), Worcester, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, USA
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  • Robert L. Davis MD, MPH,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Center for Health Studies, Group Health Cooperative, Seattle, WA, USA
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  • K. Arnold Chan MD, ScD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Channing Laboratory, Brigham and Women's Hospital, Boston, MA, USA
    3. Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA
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  • Jonathan A. Finkelstein MD, MPH,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
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  • Kris K. Fortman PhD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. HealthPartners Research Foundation, Minneapolis, MN, USA
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  • Heather McPhillips MD, MPH,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Center for Health Studies, Group Health Cooperative, Seattle, WA, USA
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  • Douglas Roblin PhD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Kaiser Permanente Georgia, Atlanta, GA, USA
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  • David H. Smith PhD, MHA,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Kaiser Permanente Northwest, Portland, OR, USA
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  • Marianne Ulcickas Yood DSc, MPH,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Henry Ford Health Systems, Detroit, MI, USA
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  • Richard Platt MD, MS,

    1. The HMO Research Network Center for Education and Research in Therapeutics, USA
    2. Channing Laboratory, Brigham and Women's Hospital, Boston, MA, USA
    3. Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
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  • Jerry H. Gurwitz MD

    1. Meyers Primary Care Institute (University of Massachusetts Medical School, the Fallon Foundation, and Fallon Community Health Plan), Worcester, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, USA
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  • No conflict of interest was declared.

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. Copyright © 2006 John Wiley & Sons, Ltd.

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