Assessment of developmental risk information on medicines for inclusion on the WHO's Essential Medicines List

Int Health. 2019 Nov 13;11(6):513-519. doi: 10.1093/inthealth/ihz006.

Abstract

Background: The WHO develops biannually an Essential Medicines List (EML) of medications proposed for national formularies to be safe, effective and cost-effective. This satisfies the priority healthcare needs of most adult populations, but it does not consider the unique toxicological risks that occur from exposures during pregnancy.

Methods: Developmental toxicity risk information for the 451 specific agents on the 2017 EML were identified from four well-recognized compendia of teratological assessments. On this basis, each agent was classified as having known, suggested, or little to no developmental risk, or as having insufficient information.

Results: Thirteen (3%) EML agents posed known developmental risks, and 115 (25%) had evidence suggesting risk. For 170 (38%) agents, there was little or no evidence of such risk. Thus, risk classification could be determined for 66% of the agents. For an additional 153 (34%) agents, the information was insufficient for classification.

Conclusion: It is feasible to expand the classification of most of the EML agents to include the risks from exposure during pregnancy.

Keywords: Essential Medicines List; WHO; birth defects; developmental toxicity; drugs in pregnancy.

MeSH terms

  • Consumer Health Information / statistics & numerical data*
  • Drugs, Essential / adverse effects*
  • Female
  • Humans
  • Pregnancy
  • Prenatal Exposure Delayed Effects*
  • Risk
  • World Health Organization

Substances

  • Drugs, Essential