title: Safety classification of herbal medicines used in pregnancy in a multinational study.
abstract: BACKGROUND
  The use of herbal medicines for health prevention and ailments is an increasing trend worldwide. Women in pregnancy are no exception; the reported prevalence of herbal medicine use in pregnancy ranges from 1 to 60 %. Despite a common perception of safety, herbal medicines may have potent pharmacological actions, and historically, have been used for this reason.
  
  
  METHODS
  A multinational, cross-sectional study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North America, and Australia. This study's primary aim was to evaluate and classify the herbal medicines used according to their safety in pregnancy and, secondly, to investigate risk factors associated with the use of contraindicated herbal medicines during pregnancy.
  
  
  RESULTS
  In total, 29.3 % of the women (n = 2673) reported the use of herbal medicines in pregnancy; of which we were able to identify 126 specific herbal medicines used by 2379 women (89.0 %). Twenty seven out of 126 herbal medicines were classified as contraindicated in pregnancy, and were used by 476 women (20.0 %). Twenty-eight were classified as safe for use in pregnancy and used by the largest number of women (n = 1128, 47.4 %). The greatest number was classified as requiring caution in pregnancy; these sixty herbal medicines were used by 751 women (31.6 %). Maternal factors associated with the use of contraindicated herbal medicines in pregnancy were found to be working in the home, having a university education, not using folic acid, and consuming alcohol. Interestingly, the recommendation to take a contraindicated herbal medicine was three times more likely to be from a healthcare practitioner (HCP) than an informal source.
  
  
  CONCLUSIONS
  Based on the current literature the majority of women in this study used an herbal medicine that was classified as safe for use in pregnancy. Women who reported taking a contraindicated herb were more likely to have been recommended it use by an HCP rather than informal source(s), indicating an urgent need for more education among HCPs. The paucity of human studies on herbal medicines safety in pregnancy stands in stark contrast to the widespread use of these products among pregnant women.
authors.affiliation: The Motherisk Program, Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada. dkennedynd@yahoo.ca.
authors.forename: D A
authors.initials: DA
authors.lastname: Kennedy
authors.affiliation: PharmacoEpidemiology and Drug Safety Research Group, School of Pharmacy, PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Postbox 1068 Blindern, 0316, Oslo, Norway.
authors.forename: A
authors.initials: A
authors.lastname: Lupattelli
authors.affiliation: The Motherisk Program, Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Koren
authors.affiliation: PharmacoEpidemiology and Drug Safety Research Group, School of Pharmacy, PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Postbox 1068 Blindern, 0316, Oslo, Norway.|Division of Mental Health, Norwegian Institute of Public Health, Oslo, Norway.
authors.forename: H
authors.initials: H
authors.lastname: Nordeng
mesh_terms: D003430:Cross-Sectional Studies; D005260:Female; D029001:Herbal Medicine / Q000145:classification*; D006801:Humans; D007391:International Cooperation; D008517:Phytotherapy; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D012449:Safety; D011795:Surveys and Questionnaires
keywords: CAM; Complementary and alternative medicine; Herbal medicine; Pregnancy; Safety