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

UMMS Affiliation

Meyers Primary Care Institute; Department of Obstetrics and Gynecology; Department of Medicine, Division of Geriatric Medicine

Publication Date


Document Type



Drug Prescriptions; Drug Therapy; Drug Utilization; Female; Health Maintenance Organizations; Humans; Physician's Practice Patterns; Pregnancy; *Teratogens; United States


Health Services Research | Obstetrics and Gynecology | Primary Care


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.

DOI of Published Version



Pharmacoepidemiol Drug Saf. 2006 Aug;15(8):546-54. Link to article on publisher's site

Journal/Book/Conference Title

Pharmacoepidemiology and drug safety

Related Resources

Link to Article in PubMed

PubMed ID