1160 Cases of Adverse Reactions Caused by Compound Liquorice Tablets and Risk Factors

doi:10.19803/j.1672-8629.2021.12.17

Abstract

Abstract: Objective To investigate the characteristics of and risk factors for adverse drug reactions (ADRs) caused by compound liquorice tablets in order to offer reference for clinical rational drug use.Methods A retrospective analysis was made of 1 160 ADR reports of compound liquorice tablets in Shandong ADR database (from January 1, 2004 to December 31, 2019). Results The adverse reactions related to compound liquorice tablets were mainly manifested as the damage to multiple systems and organs, such as the gastrointestinal tract, skin and its accessories. Nausea was the most common adverse reaction, and anaphylactic shock was the most severe one. Risks of hypokalemia, edema, hypotension and drug dependence were not mentioned in the instructions.Conclusion Manufacturers should carry out safety inspections of compound liquorice tablets and update the instructions in time. Health care providers and dealers of pharmaceuticals should become better informed of this drug. In particular, the risk of drug dependence caused by long-term medication should be minimized to ensure the safety of medications.

Key words: compound liquorice tablets, adverse drug reactions, risk analysis

CLC Number:

R969.3R994.11

HUO Yanfei, XIE Yanjun, XU Lili, CHANG Hong, SUN Chunxiao, TIAN Yuejie. 1160 Cases of Adverse Reactions Caused by Compound Liquorice Tablets and Risk Factors[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1176-1180.

References

[1] National Medical Products Administration. Notice on Effectively Strengthening the Sales Management of Part of Compound Preparation Containing Special Drugs [EB/OL]. (2009-08-18) [2019-06-03]. http://www.nmpa.gov.cn/WS04/CL2196/323743.html.
[2] National Medical Products Administration. Notice of the General Office of the State Food and Drug Administration on Further Strengthening the Purchase and Sale Management of Compound Oral Solution, Compound Liquorice Tablet and Compound Diphenoxylate Tablet[EB/OL].(2013-07-08)[2019-06-15]. http://www.nmpa.gov.cn/WS04/CL2196/324008.html.
[3] National Medical Products Administration. Notice of the General Office of the Food and Drug Administration on Further Strengthening the Purchase and Sale Management of Oral Compound Formulations containing Narcotic Drugs and Tramadol. [EB/OL]. (2014-06-05) [2019-06-27]. http://www.nmpa.gov.cn/WS04/CL2196/324062.html.
[4] National Medical Products Administration. Announcement on Revising the Instructions of Compound Liquorice Tablet (No. 14, 2020) [EB/OL].(2020-03-03) [2020-03-24]. http://www.nmpa.gov.cn/WS04/CL2115/375249.html.
[5] Liu ZD, Liu XL, Yang L.A case of anaphylactic shock induced by compound liquorice tablets[J]. Chinese Journal of Misdiagnosis(中国误诊学杂志), 2008, 8(31) : 7812.
[6] Wang ZJ, Wei CQ, Ma AJ.A case of anaphylactic shock induced by compound liquorice tablets[J]. Medicine Industry Information(医药产业资讯), 2006, 3(5): 84.
[7] Zhao HP, Guo YC.Report of anaphylactic shock induced by compound liquorice tablets[J]. Journal of Practical Traditional Chinese Medicine(实用中医药杂志), 2005, 21(2): 107.
[8] Li H.A case of addiction caused by long-term oral administration of compound liquorice tablets[J]. Chinese Journal of Clinical Rational Drug Use(临床合理用药杂志), 2017,10(28): 168.
[9] Zhang N, Luo LX, Zhang ZW.A case report of withdrawal symptoms caused by oral high dose compound liquorice tablets[J]. Chongqing Medicine(重庆医学), 2016, 45(9): 1288-1289.
[10] Tang MQ.Three cases of addiction caused by compound liquorice tablets[J]. Herald Medicine(医药导报), 2003, 22(3): 195.
[11] Wang YX, Yu JH.Two cases of urinary retention caused by compound liquorice tablets[J]. Central Plains Medical Journal(中原医刊), 1985(3): 43.
[12] Fu X, Wu YB.One case of hypokalemia caused by compound liquorice tablets[J]. Medical Journal of the Chinese People’s Armed Police Force(武警医学), 2018, 29(12) : 1163-1164.
[13] Su WL, Yang Y, Miao F, et al.Two cases of hypokalemia caused by compound liquorice tablets[J]. China Journal of Hospital Pharmacy(中国医院药学杂志), 2015, 35(15) : 1439-1440.
[14] Li YJ, Wang DN, Miao QL, et al.One case of severe hypokalemia caused by compound liquorice tablets[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(1) : 58-60.
[15] Na KX.Long-term use of compound liquorice tablets should be vigilant against the occurrence of hypokalemia[J]. Chinese Journal of Clinicians(中国临床医生杂志), 2019, 47(7) : 757-758.
[16] Feng Y, Ma CL, Zhu J.A case of hypertensive crisis caused by compound liquorice tablets[J]. Evaluation and Analysis of Drug-Use in Hospitals of China(中国医院用药评价与分析), 2013, 13(3): 287.
[17] Wang H.A case of facial and lower limb edema caused by compound liquorice tablets[J]. Chinese Journal of Convalescent Medicine(中国疗养医学), 2013, 22(1): 79.
[18] Li JP, Wu LZ.A Meta-analysis of electroacupuncture for treatment of opiate dependence[J]. Chinese Journal of Drug Dependence(中国药物依赖性杂志), 2014,23(1): 28-35.
[19] Pu B, Xie FD.A case of severe urinary retention induced by morphine controlled-release tablets[J]. Chinese Journal of Misdiagnosis(中国误诊学杂志), 2008, 8(2): 493.