Abstract

The purpose of this study was to investigate the drugs prescribed for pregnant women at Tokushima University Hospital in Japan, and to evaluate the risks associated with the use of these drugs during pregnancy according to the pregnancy risk classification systems of the FDA, ADEC and that used in manufacturers’package inserts.Of 496 female outpatients who gave birth at Tokushima University Hospital, 81% had been prescribed at least one drug, and the mean was 4.0 drugs per patient.Analysis of the prescriptions revealed a pattern of drug use very different from that in other countries, in that Kampo (Japanese herbal) medicines were also prescribed.For more than half of the oral drugs prescribed, risks were not given in the FDA and/or ADEC pregnancy risk systems.In addition, there was no listing of pregnancy risks in the package inserts of 20 drugs.We therefore consider it to be very important to develop a globally harmonized system for evaluating the risks associated with prescription drugs taken during pregnancy.

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