Evaluation of Drugs Exposure in Pregnancy According to Different Risk Categories: Do FDA-Based Decisions Lead to More Curettage?

Demir Ö., Arıcı M. A., Demiral Y., Tunçok Y.

TURKIYE KLINIKLERI TIP BILIMLERI DERGISI, cilt.32, sa.4, ss.901-909, 2012 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 32 Sayı: 4
  • Basım Tarihi: 2012
  • Doi Numarası: 10.5336/medsci.2011-22838
  • Dergi Adı: TURKIYE KLINIKLERI TIP BILIMLERI DERGISI
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.901-909
  • Anahtar Kelimeler: United States Food and Drug Administration (FDA), teratogens, congenital abnormalities, abnormalities, drug-induced, catalogs, drug, drug toxicity, drug toxicity, POSTMARKETING SURVEILLANCE, CLASSIFICATION, PRESCRIPTION, TERATOGENICITY, INFORMATION, EXPERIENCE, SYSTEM
  • Dokuz Eylül Üniversitesi Adresli: Evet

Özet

Objective: The aims of the study were to compare the risk levels of exposed drugs during pregnancy with regard to United States Food and Drug Administration (FDA), Australian Drug Evaluation Committee (ADEC) and Teratogen Information System (TERIS) risk categories, and to determine the outcomes of FDA risk category based decisions on the course of pregnancy in pregnant women who applied to Dokuz Eylul University (DEU) Teratogenity Information Service (TIS). Material and Methods: In this cross-sectional study, 220 pregnant women were enrolled who referred to DEU TIS for a teratogenity risk evaluation due to drug exposure during their pregnancies. Demographics, medical history, time and duration of the exposed drugs were recorded. Drugs exposed during pregnancy were divided into two categories as high or low risk. A drug that was exposed during pregnancy of the highest risk according to FDA was taken into consideration for the evaluation of the outcomes of the pregnancy. Additionally, FDA, TERIS and ADEC risk categories which were classified as "low", "unknown" or "high" risk were compared with each other to evaluate the agreement of the pregnancy risk categories. Results: The voluntary or medical curettage ratio was higher in pregnant women with high-risk drug exposure compared to low risk drug exposure, regarding FDA teratogenity risk categories (OR: 2.32, CI: 1.13-4.77, p=0.032). Fair or moderate agreements were demonstrated among FDA, ADEC and TERIS risk categories. The kappa coefficients of FDA-ADEC, TERIS-ADEC and TERIS-FDA were 0.379, 0.454 and 0.221, respectively. Conclusion: Although exposure of pregnant women to high risk drugs according to FDA risk categories was found to be associated with increased voluntary or medical curettage rates, results of epidemiologic studies should be taken into consideration in the assessment of teratogenic risks due to the poor agreements among pregnancy risk categories.