A comparative study of risk classification systems for drug use during pregnancy / 中国药学杂志

ABSTRACT

OBJECTIVE: To compare and analyze three risk classification systems for drug use during pregnancy, so as to provide evidence for drug safety used in pregnancy. METHODS: The drugs included in the risk classification systems from the US Food and Drug Administration (FDA), the Australian Drug Evaluation Committee (ADEC) and the Swedish Catalogue of Approved Drugs (FASS) were searched, and descriptive analysis was performed in terms of definition of category, allocation of drugs and difference of categories. RESULTS: FDA uses animal studies and human observations studies in pregnancy to define the risk of drugs in pregnancy. The classification systems of ADEC and FASS are similar, which use experience in human and animal research for defining the drug safety during pregnancy. The category assignments for 1113 drugs in FDA system, 1232 in ADEC system and 983 in FASS system were compared. Only 367 (11.6% ) drugs among the total of 3167 in the three systems were placed in the same risk level category, which accounted for 33.0%, 29. 8% and 37.3% of FDA, ADEC and FASS systems, respectively. The main differences existed in drugs in X and C categories between FDA and ADEC/FASS systems. CONCLUSION: Differences in category allocation for the same drug can be a source of great confusion among users of the classification systems, and may limit the usefulness and reliability of risk classification systems.