Study on Drospirenone and Ethinylestradiol Tablets Using FDA Public Data Program

Abstract

Abstract: Objective To understand the drug adverse reaction of drospirenone and ethinylestradiol tablets and discuss the characteristics and feasibility of FDA public data program (openFDA) through analyzing adverse reactions reports from the openFDA. Methods The openFDA database was searched with term"drospirenone and ethinylestradiol" from January 1, 2001 to December 31, 2014, and the data was transformed and analyzed by R software with jsonlite package. Results 38617 reports were retrieved, and the distribution of received date showed a curve of rises first and then fall with the turning point occurred in May,2011 when FDA published safety review of possibly increased risk of blood clots with birth control pills containing drospirenone. The mean age of patients was 30.02 years, the top three drugs use indications were contraception, acne and premenstrual syndrome, and the top three adverse reactions were pain, injury and pulmonary embolism. Conclusion Compared with the FAERS database, openFDA simplifies the data cleaning procedure, which is a more convenient way to get to know adverse reactions of certain drug, however, problems on the quality of raw data still exist, which would affect the accuracy of analysis result , therefore, the mining of adverse reaction signals using openFDA comparatively has better potential applications.

Key words: openFDA, drospirenone and ethinylestradiol tablets, FAERS, drug adverse reaction

CLC Number:

R951

SHI Wen-hui, CHEN Ying, YAO Jie, SUN Zhi-ming, XU Hao-qin. Study on Drospirenone and Ethinylestradiol Tablets Using FDA Public Data Program[J]. Chinese Journal of Pharmacovigilance, 2015, 12(9): 552-555.

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