Analysis of 156 Cases of Adverse Drug Reactions/Medical Device Events Induced by Levonorgestrel-releasing Intrauterine System

Abstract

Abstract: Objective To explore the characteristics of adverse drug reactions（ADRs）/medical device events（MDEs）caused by the levonorgestrel-releasing intrauterine system (LNG-IUS). Methods 156 cases of ADRs/MDEs caused by LNG-IUS were analyzed via retrospective study in terms of ages, time distribution and manifestation. Results The LNG-IUS was mainly placed in hospital, 85 cases were menstruproblems (54.49%), of which 31 cases were absence of menstruation (36.47%). Conclusion The most information on LNG-IUS was from hospital and doctor. Recommendation of doctor was important for using LNG-IUS. The main ADR/MDE of LNG-IUS was the change of menstruation. Informed consent should be done before using LNG-IUS. The LNG-IUS has the characteristics of drug and medical device, once taken out because of the drug, both ADR and MDE reports should be sabmitted.

Key words: levonorgestrel-releasing intrauterine system (LNG-IUS), adverse drug reaction, medical device event, analysis

CLC Number:

R994.11

ZHANG Min, SUN Zhi-ming, XU Hao-qin, YANG Yue-hua. Analysis of 156 Cases of Adverse Drug Reactions/Medical Device Events Induced by Levonorgestrel-releasing Intrauterine System [J]. Chinese Journal of Pharmacovigilance, 2016, 13(5): 295-297.

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