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

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.