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Fetal Harm (fetal + harm)
Selected AbstractsUse of prescription medications with a potential for fetal harm among pregnant women,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2006Susan E. Andrade ScD 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. [source] Prescriptions filled during pregnancy for drugs with the potential of fetal harmBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 13 2009S Kulaga Objective, To assess the extent of prescriptions filled by pregnant women for drugs with recognised potential of fetal harm, and to document the outcomes of these pregnancies. Design, Cross-sectional study. Population, Quebec Pregnancy Registry. Methods, We identified women who were pregnant during a five-year period and who were insured for prescription medications under the provincial drug plan. We obtained information on prescriptions filled during pregnancy for drugs with known potential of fetal harm. Main outcome measures, Prescriptions filled for study drugs during the first, second and third trimesters of pregnancy; termination of pregnancy (TOP) or delivery, and whether the baby was diagnosed with a major congenital malformation (MCM). Results, Of 109 344 women, 56% filled at least one prescription for a medication during pregnancy; 6.3% filled at least one prescription for a drug known to pose a risk to the fetus. Overall, 47% (95% CI, 45.8,48.2) of pregnancies exposed to drugs under study ended in TOP versus 36.2% (95% CI, 35.9,36.5) of those not exposed; 8.2% (95% CI, 8.0,10.0) of live births were diagnosed with an MCM during the first year of life versus 7.1% (95% CI, 6.9,7.3) of those not exposed. Conclusions, This study documents an important level of prescriptions filled during pregnancy for drugs harmful to the developing fetus. The proportions of both TOPs and babies born with MCMs were elevated compared with the expected values. Clinicians caring for women during pregnancy should conduct a medication inventory prior to a planned pregnancy, or as soon as an unplanned pregnancy is recognised. [source] | ||||||||||