Development of a drug safety monitoring system for the detection of drug safety signals in pregnancy.

2021 Fiscal Year Final Research Report

• Project/Area Number: 19K16457
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: Meijo University
• Principal Investigator: SAKAI Takamasa 名城大学, 薬学部, 助教 (60826923)
• Project Period (FY): 2019-04-01 – 2022-03-31
• Keywords: 妊婦 / シグナル / 医薬品安全性監視 / 自発報告 / JADER / FAERS

Outline of Final Research Achievements

This study aimed to identify possible undiscovered adverse drug reactions in pregnant women by using the spontaneous reporting databases.
First, we evaluated an analytical method for detecting drug safety signals by extracting cases regarding pregnant women from the spontaneous reporting databases and found that drug safety signals could be detected with a certain level of sensitivity. We then used this method to analyze the Japanese and U.S. spontaneous report databases and found a drug safety signal of pregnancy loss associated with latanoprost eye drops.

Free Research Field

薬剤疫学

Academic Significance and Societal Importance of the Research Achievements

本研究の解析手法を用いることで、妊婦において未だ発見されていない医薬品の副作用の可能性をより早期に見出すことができ、妊婦を対象とした医薬品安全性監視を充実させることが期待される。倫理的な理由から臨床研究の対象となりにくい妊婦において、受動的サーベイランスの情報から検討可能という点からも、本研究成果は有用な知見であると考えられる。