535 reports of new and serious adverse drug reactions caused by preparations of lappaconitine hydrobromide

doi:10.19803/j.1672-8629.20220602

Abstract

Abstract: Objective To study the clinical manifestations of adverse drug reactions (ADR) caused by lappaconitine hydrobromide as reference for clinical rational drug use. Methods A total of 535 reports of new and serious ADR involving lappaconitine hydrobromide in Shandong Provincial ADR Database from January 1, 2011 to December 31, 2021 were retrospectively analyzed. Results The new and serious adverse reactions of lappaconitine hydrobromide were more prevalent in people ages 45~65, and most of the ADR occurred within one day of administration. The ADR of lappaconitine hydrobromide mainly presented as multiple systemic and organ damage such as gastrointestinal damage, systemic damage, and damage to the skin and its attachments. The risks of abnormal liver function, allergic reactions or anaphylactic shock were not mentioned in the instructions. Conclusion The warning in the instructions for preparations of lappaconitine hydrobromide is inadequate. Marketing authorization holders need to study post-marketing data and improve the instructions to ensure the safety of patients.

Key words: lappaconitine hydrobromide, rational drug use, adverse drug reaction(ADR), abnormal liver function, shock

CLC Number:

R971
R994.11

HUO Yanfei, TIAN Yuejie, XU Lili, XIE Yanjun, CHANG Hong, SUN Chunxiao, LI Xia. 535 reports of new and serious adverse drug reactions caused by preparations of lappaconitine hydrobromide[J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 921-926.

References

[1] LI SS, ZHANG HB, ZHU XY, et al.Research progress on new preparations of lappaconitine[J]. Drugs & Clinic(现代药物与临床), 2014, 29(7): 818-823.
[2] OU S, ZHAO YD, XIAO Z, et al.Effect of lappaconitine on neuropathic pain mediated by P2X3 receptor in rat dorsal root ganglion[J]. Neurochem Int, 2011, 58(5): 564-573.
[3] WANG YZ, XIAO YQ, ZHANG C, et al.Study of analgesic and anti-inflammatory effects of lappaconitine gelata[J]. J Tradit Chin Med, 2009, 29(2): 141-145.
[4] LIN MJ, YANG XX.Effect of lappaconitine on analgesia and local anesthesia in rats with surgical pain[J]. Strait Pharmaceutical Journal(海峡药学), 2011, 23(4): 29-31.
[5] National Medical Products Administration. Drug query[EB/OL].[2022-10-28]. https://www.nmpa.gov.cn/yaopin/index.html.
[6] SUN Y.Drug therapy for cancer pain[J]. Journal of Qilu Oncology(齐鲁肿瘤杂志), 1997, 4(3): 7-8.
[7] WEI HB, ZHANG BH, TAN B, et al.Research progress on pharmacological effects and clinical application of lappaconitine hydrobromide[J]. Chongqing Medicine(重庆医学), 2014, 43(20): 2660-2662.
[8] SHI HX.Clinical nursing of 1 case of anaphylactic shock induced by lappaconitine hydrobromide[J]. Journal of Qilu Nursing(齐鲁护理杂志), 2015, 21(3): 94-95.
[9] HE Y, CAO DP, CHEN F.Anaphylactic shock leading to death induced by lappaconitine hydrobromide for injection[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2017, 19(2): 145-147.
[10] ZHANG JL.One case of allergic reaction induced by lappaconitine hydrobromide injection[J]. Journal of Bethune Military Medical College(白求恩军医学院学报), 2007, 5(1): 16.
[11] XU JH, ZHOU QH, YANG WY, et al.A case of severe allergic reaction induced by lappaconitine hydrobromide[J]. Chinese Journal of Anesthesiology(中华麻醉学杂志), 2004, 24(7): 20.
[12] LIN PF, ZHANG YK.One case of allergic reaction induced by intravenous infusion of lappaconitine hydrobromide powder injection[J]. China Pharmaceuticals(中国药业), 2013, 22(22): 53.
[13] WANG MY, ZHANG YK.One case of shivering fever caused by lappaconitine hydrobromide[J]. People's Military Surgeon(人民军医), 2016, 59(10): 1035.
[14] WU T, TIAN YJ.One case of high fever and chill caused by lappaconitine hydrobromide for injection[J]. The Medical Forum(基层医学论坛) 2017, 21(20): 2689-2691.
[15] SUN P, WANG HY, WEI J.One case of lappaconitine hydrobromide poisoning[J]. Northwest Pharmaceutical Journal(西北药学杂志),1997, 12(5): 200.
[16] WEI HB, FAN XL, QIN ZP.Two cases of ototoxicity induced by lappaconitine hydrobromide for injection[J]. Chinese Journal of Hospital Pharmacy(中国医院药学杂志), 2012, 32(17): 1413-1414.
[17] WEI HB, SHU C, LI L, et al.Parkinson-like syndromes induced by lappaconitine hydrobromide for injection[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 2020, 22(1): 50-51.
[18] LI QC, GAO YL, WAN B.Literature review on adverse reactions of lappaconitine hydrobromide[J]. Chinese Journal of Drug Abuse Prevention and Treatment(中国药物滥用防治杂志), 2018, 24(2): 114-115.
[19] National Medical Products Administration. Announcement on Revising the Instructions of Lappaconitine hydrobromide injection(国家药监局关于修订氢溴酸高乌甲素注射剂说明书的公告) [EB/OL]. (2020-04-25)[2020-05-09]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20220425084456109.html.
[20] LI PH, FENG QQ.Discussion of quality control methods of adverse drug reaction reports[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2011, 8(10): 608-610.
[21] National Medical Products Administration. Administrative Measures for Adverse Drug Reaction Reporting and Monitoring (药品不良反应报告和监测管理办法) [EB/OL].(2011-05-04)[2022-02-22]. ttps://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20110504162501325_7.html.
[22] MEDICOM. Home page[EB/OL].[2022-02-22]. http://www.medicom.com.cn/.
[23] ZHANG T.A comparative study on hospitalization health expenditure between surgery patients with different types of admissions in some three-level hospital[D]. Ji'nan: Shandong University, 2016.
[24] National Medical Products Administration. National ADR Monitoring Annual Report (2021)(国家药品不良反应监测年度报告2021)[EB/OL].(2022-03-30) [2022-11-03]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20220329161925106.html.
[25] SUN WM, YANG JH, SONG QW, et al.An observation on compatibility of lappaconitine hydrobromide injection with four other kinds of injection[J]. Journal of Guiyang Medical College(贵阳医学院学报), 2004, 29(3): 229-231.
[26] ZHANG LJ, LI Y, ZHANG YX, et al.Study of acute toxicity different extraction parts of aconitum sinomontanum nakai on mice[J]. Chinese Journal of Information on Traditional Chinese Medicine(中国中医药信息杂志), 2018, 25(3): 53-57.
[27] CHEN L, CAI SY, LU QH.LC-Q-TOF/ MS analysis of related substances in lappaconitine hydrobromide and its injection[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2013, 33(12): 2129-2134.
[28] LI X, TIAN YJ, HUO YF,et al.Analysis of adverse drug reaction and risk factors induced by lappaconitine hydrobromide injection[J]. Food and Drug(食品与药品), 2022, 24(5): 442-446.
[29] National Medical Products Administration. Provisions on the Administration of Drug Instructions and Labels (药品说明书和标签管理规定)[EB/OL].(2006-03-15) [2022-11-07]. https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20060315010101975.html.
[30] LI DB, SHU K, DU Y.Clinical analysis of phloroglucinol combined with lappaconitine hydrobromide in the treatment of acute gastric spasm[J]. Journal of Modern Medicine & Health(现代医药卫生), 2018, 34(2): 247-248.
[31] National Medical Products Administration. Announcement of the State Food and Drug Administration on the Issuance of the Pharmacovigilance Quality Management Standard(《药物警戒质量管理规范》的公告) [EB/OL].(2021-05-13) [2022-11-02]. https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfggzwj/20210513151827179.html.