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

Susan E. Andrade, Marsha A. Raebel, Abraham N. Morse, Robert Davis, K. Arnold Chan, Jonathan A. Finkelstein, Kris K. Fortman, Heather Mcphillips, Douglas Roblin, David H. Smith, Marianne Ulcickas Yood, Richard Platt, Jerry H. Gurwitz

Research output: Contribution to journalArticle

81 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)546-554
Number of pages9
JournalPharmacoepidemiology and Drug Safety
Volume15
Issue number8
DOIs
StatePublished - Aug 1 2006
Externally publishedYes

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Prescriptions
Pregnant Women
Teratogens
Prescription Drugs
Health Maintenance Organizations
United States Food and Drug Administration
Pregnancy
Term Birth
Therapeutic Human Experimentation
Ovulation
Pharmaceutical Preparations
Documentation
Retrospective Studies
Databases
Physicians
Education
Research

All Science Journal Classification (ASJC) codes

  • Epidemiology
  • Pharmacology (medical)

Cite this

Andrade, S. E., Raebel, M. A., Morse, A. N., Davis, R., Chan, K. A., Finkelstein, J. A., ... Gurwitz, J. H. (2006). Use of prescription medications with a potential for fetal harm among pregnant women. Pharmacoepidemiology and Drug Safety, 15(8), 546-554. https://doi.org/10.1002/pds.1235

Use of prescription medications with a potential for fetal harm among pregnant women. / Andrade, Susan E.; Raebel, Marsha A.; Morse, Abraham N.; Davis, Robert; Chan, K. Arnold; Finkelstein, Jonathan A.; Fortman, Kris K.; Mcphillips, Heather; Roblin, Douglas; Smith, David H.; Yood, Marianne Ulcickas; Platt, Richard; Gurwitz, Jerry H.

In: Pharmacoepidemiology and Drug Safety, Vol. 15, No. 8, 01.08.2006, p. 546-554.

Research output: Contribution to journalArticle

Andrade, SE, Raebel, MA, Morse, AN, Davis, R, Chan, KA, Finkelstein, JA, Fortman, KK, Mcphillips, H, Roblin, D, Smith, DH, Yood, MU, Platt, R & Gurwitz, JH 2006, 'Use of prescription medications with a potential for fetal harm among pregnant women', Pharmacoepidemiology and Drug Safety, vol. 15, no. 8, pp. 546-554. https://doi.org/10.1002/pds.1235
Andrade, Susan E. ; Raebel, Marsha A. ; Morse, Abraham N. ; Davis, Robert ; Chan, K. Arnold ; Finkelstein, Jonathan A. ; Fortman, Kris K. ; Mcphillips, Heather ; Roblin, Douglas ; Smith, David H. ; Yood, Marianne Ulcickas ; Platt, Richard ; Gurwitz, Jerry H. / Use of prescription medications with a potential for fetal harm among pregnant women. In: Pharmacoepidemiology and Drug Safety. 2006 ; Vol. 15, No. 8. pp. 546-554.
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