Risks to safety of vitamin B2 injection

doi:10.19803/j.1672-8629.20230269

Abstract

Abstract: Objective To analyze the safety risks posed by vitamin B₂ injection in China in order to provide reference for clinical rational drug use. Methods Individual cases of adverse drug reactions retrieved from WHO Vigilyze and China adverse drug reaction database, foreign and domestic literature were analyzed. Results The risks posed by vitamin B₂ injection, including cutaneous diseases, general disorders and gastrointestinal system damage, deserved more attention. Conclusion Drug marketing authorization holders should reinforce the safety monitoring of vitamin B₂ injection, update the drug labeling without delay and promote the rational use of medicine.

Key words: vitamin B₂, injection, adverse drug reaction, safety, regulatory measures, instruction, marketing authorization holder

CLC Number:

YANG Le, XIA Dongsheng, WANG Tao. Risks to safety of vitamin B₂ injection[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1256-1258.

References

[1] Sean C Sweetman Martindale. The Complete Drug Reference[M]. 37th ed, Beijing: Chemical Industry Press, 2013.
[2] National Medical Security Bureau. List of national basic medical insurance, industrial injury insurance and maternity insurance drugs (2022 version) [EB/OL].(2023-01-13)[2023-04-30]. http://www.gov.cn/zhengce/zhengceku/2023-01/18/content_5737840.htm.
[3] Chinese Pharmacopoeia Commission.Pharmacopoeia of the People’s Republic of China,Volume II(中华人民共和国药典二部)[M]. Beijing: China Medical Science Press, 2015.
[4] National Medical Products Administration. [EB/OL].(2020-08-31) [2023-04-30]. https://www.nmpa.gov.cn/datasearch/search-result.html).
[5] Uppsala Monitoring Centre.Vigilyze[EB/OL].[2023-05-01].https://vigilyze.who-umc.org.
[6] LYU DL, LONG P, WU FJ.Analysis of adverse events of 6 cases of riboflavin sodium phosphate injection[J]. Journal of Pharmacoepidemiology(流行病学杂志), 2013, 22(5): 276-277.
[7] ZHAO XQ, XU XY.Riboflavin sodium phosphate injection caused drug fever: 3 cases[J]. Journal of Clinical Rational Drug Use(临床合理用药杂志), 2010, 3(17): 112.
[8] LIU XY, ZHANG FF, LI SS.Nursing warning of sweating caused by intravenous infusion of riboflavin sodium phosphate[J]. Straits Pharmacy(海峡药学), 2010, 22(8): 267.
[9] SU J, WEI Q, SUN Y.Sodium riboflavin phosphate caused chills and fever in 3 cases[J]. Chinese Pharmacist(中国药师), 2008(10): 1239.
[10] QU SJ.Adverse reactions caused by riboflavin sodium phosphate injection: 1 case[J]. Chinese Journal of Misdiagnosis(中国误诊学杂志), 2010, 10(21): 5287.
[11] XU XY.Sodium riboflavin phosphate injection caused drug fever: 2 cases[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2011, 8(4): 249.
[12] YE CY, XU TM.Riboflavin sodium phosphate-induced parotid gland enlargement in 1 case[J]. Chinese Journal of New Drugs and Clinical Practice(中国新药与临床杂), 2009, 28(12): 955-956.
[13] LIANG H, E GX. Sodium riboflavin phosphate for injection causes chills and fever: 1 case[J]. Journal of Youjiang Medical College for Nationalities(右江民族医学院学报), 2013, 35(5): 690.
[14] WEI C, KONG FF.Severe skin allergic reaction caused by intravenous infusion of riboflavin sodium phosphate and vitamin C injection for injection: 1 case[J]. Journal of Clinical Rational Drug Use(临床合理用药杂志), 2016, 9(5): 88.
[15] PAN XF, HE JB, CHEN AH.Allergic reactions caused by sodium riboflavin phosphate for injection: 3 cases[J]. Straits Pharmacy(海峡药学), 2010, 22(7): 253-254.
[16] WU Y.Analysis of 35 cases of riboflavin adverse reactions[J]. Sino-Foreign Health Abstract(中外健康文摘), 2013, 24(10): 184.
[17] NMPA. Announcement of the National Medical Products Administration on the amendment of the manual for vitamin B2 injection (No.69 of 2020)
[EB/OL].(2020-06-02)[2020-06-11]. https://www.nmpa.gov.cn/xxgk/ggtg/ypshmshxdgg/20200611161001824.html.

Risks to safety of vitamin B₂ injection

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics

[1]	JIA Yinyin, ZHANG Caishu, ZHOU Ying, LIU Li, GENG Ying, WEI Ningyi, NIU Sijing, CHEN Hua, XU Hui. Evaluation methods for aerodynamic particle size distribution of fine particles in inhaled products [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 141-146.
[2]	JIA Jinsheng, LIU Hongliang, WANG Qing, HOU Yongfang, LI Xinling. Evaluation of the relevance of adverse drug reaction based on ERNIE-DPCNN [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 163-166.
[3]	MA Meiying, ZHAO Xiaopei, ZHANG Mengyao, HU Yilin. Drug traceability coding system in China [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 167-172.
[4]	ZHANG Jian, FANG Huihua. Applicability of evaluation standards for use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 185-189.
[5]	LI Yingfen, HAN Lei. Analysis of 319 cases of adverse drug reaction induced by cerebroprotein hydrolysate for injection [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 195-198.
[6]	XU Weijia, PENG Qi, HUANG Haiyu, ZHANG Leijiao, XIAO Hua, WU Xue. 285 cases of adverse drug reaction related to new antineoplastic drugs [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 199-203.
[7]	GUO Qinghua, PENG Xiaoxiao, ZHU Ping, LIU Xilin, YANG Yinghua, CHEN Zhihai. One case of multiple organ dysfunction syndrome caused by amlodipine overdose [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 204-207.
[8]	FANG Meilin, ZHENG Huimin, WANG Cunze, WANG Ling, RUAN Junshan. One case of generalized myalgia caused by oxaliplatin [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 208-210.
[9]	LI Na, GUO Jun, GUO Wenjia, LYU Yinyin, LI Caihong, MU Xiangdong. One case of delayed skin allergic reaction caused by asthma treated with omalizumab injection [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 211-212.
[10]	CHEN Yuyan, ZHANG Mingxia, ZHANG Tao, ZHANG Jin. One case of interstitial pneumonia caused by serplulimab injection [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 213-215.
[11]	CAO Guiping, DENG Linlin, ZHU Ganhong, LU Ying, MA Shuang, CHEN Linlin, Liu Lili. One case of severe liver injury caused by Tianma Shouwu tablets [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 216-218.
[12]	BAI Zhaofang, ZHAN Xiaoyan, YAO Qing, CHEN Simin, ZHAO Xu, XIAO Xiaohe. Theoretical innovation and technological breakthroughs in the safety evaluation of traditional Chinese medicine: disease-syndrome-based toxicology [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 6-14.
[13]	GUO Longxin, GAO Yunjuan, WU Chengzhao, LONG Minjuan, ZHU Shengkai, SONG Haibo, ZHAO Xu, XIAO Xiaohe. Exploring new risk signals and susceptibility factors of traditional Chinese medicine-induced hepatotoxicity based on big data from adverse reaction monitoring [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 15-19.
[14]	FANG Zhie, LI Chengxian, BAI Zhaofang, ZHAO Xu, WANG Jiabo, XIAO Xiaohe. Investigation of objectivity in the relationship between aristolochic acid and hepatocellular carcinoma [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 20-24.
[15]	XIONG Weiyi, REN Jingtian. Considerations for revision of safety information in package inserts of anti-cancer drugs in post-market phase [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 94-97.