Maternal characteristics associated with pregnancy exposure to FDA category C, D, and X drugs in a Canadian population

Pharmacoepidemiol Drug Saf. 2008 Mar;17(3):270-7. doi: 10.1002/pds.1538.

Abstract

Purpose: To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure.

Methods: A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures.

Results: A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were <20 years of age, who had a parity > or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs.

Conclusions: About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Chronic Disease
  • Confidence Intervals
  • Databases, Factual
  • Drug Prescriptions / classification
  • Drug Prescriptions / statistics & numerical data*
  • Drug Utilization / statistics & numerical data*
  • Drug-Related Side Effects and Adverse Reactions / classification*
  • Female
  • Humans
  • Logistic Models
  • Odds Ratio
  • Parity
  • Pharmaceutical Preparations / administration & dosage*
  • Pharmaceutical Preparations / classification
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Risk Factors
  • Saskatchewan
  • Socioeconomic Factors
  • United States
  • United States Food and Drug Administration

Substances

  • Pharmaceutical Preparations