Research on signal mining of adverse events of tizanidine based on FAERS database

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Author: LIU Yanxin ^1# DONG Changjiang ^1# ZOU Jian ¹  CHEN Li ^2, ³ SHU Yamin ⁴ HE Xucheng ⁵ WU Pan ⁶

Affiliation: 1. Department of Pharmacy, Pengzhou People's Hospital, Pengzhou 611930, Sichuan Province, China 2. Department of Pharmacy / Center for Evidence-based Pharmacy, West China Second Hospital, Sichuan University, Chengdu 610041, China 3. Key Laboratory of Birth Defects and Related Gynecological Diseases, Ministry of Education, Chengdu 610041, China 4. Department of Pharmacy, Tongji Hosiptal ,Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430030, China 5. Department of Pharmacy, Pengzhou Second People's Hospital, Pengzhou 611934, Sichuan Province, China 6. Department of Pharmacy, Chengfei Hospital, Chengdu 610091, China

Keywords: Tizanidine FAERS database Adverse drug event Signal mining Pharmacovigilance

DOI: 10.12173/j.issn.1005-0698.202312038

Reference: LIU Yanxin, DONG Changjiang, ZOU Jian, CHEN Li, SHU Yamin, HE Xucheng, WU Pan.Research on signal mining of adverse events of tizanidine based on FAERS database[J].Yaowu Liuxingbingxue Zazhi,2024, 33(2):166-175.DOI: 10.12173/j.issn.1005-0698.202312038.[Article in Chinese]  Copied

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Abstract

Objective Based on U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, the signal mining of tizanidine adverse drug events (ADEs) was conducted to explore the occurrence characteristics of ADE, hoping to provide references for the safe clinical application of tizanidine.

Methods The reporting odds ratio (ROR) and medicines and healthcare products regulatory agency methods (MHRA) were used to analyse the ADE of tizanidine using FAERS registration data from the first quarter of 2004 to the second quarter of 2022. After valid signals were obtained, the MedDRA was used for translation and system organ classification.

Results A total of 7 135 reports of tizanidine ADE were obtained, including 1 732 patients, 1 304 ADE types were involved. According to the results of 2 ADE signal mining methods, at the preferred term (PT) level, 177 signals were detected. There were 32 PT signals not included in the drug instructions, including potassium wasting nephropathy, cardio-respiratory arrest, and foetal growth restriction etc. In 1 732 patients, the number of ADE cases of female was 2.37 times that in male (1 057 vs. 446), and the age group between 40 and 64 accounted for a large proportion (36.03%). The highest proportion (32.79%) reported by consumers. The system organ class involved mainly included various neurological diseases and psychosis. The median time to onset of tizanidine-related ADEs was 75 d (interquartile range: 28-223 d), but it was necessary to be vigilant that ADE may still occur 1 year after starting the drug (13.38%).

Conclusion This study aims to suggest that clinical application of tizanidin-related ADE should be paid full attention to the occurrence of ADE such as potassium-wasting nephropathy and suicidally completed, as well as key populations such as women and patients of 40-64 years old.

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1.Gelber DA, Good DC, Dromerick A, et al. Open-label dose-titration safety and efficacy study of tizanidine hydrochloride in the treatment of spasticity associated with chronic stroke[J]. Stroke, 2001, 32(8): 1841-1846. DOI: 10.1161/01.str.32.8.1841.

2.Malanga G, Reiter RD, Garay E. Update on tizanidine for muscle spasticity and emerging indications[J]. Expert Opin Pharmacother, 2008, 9(12): 2209-2215. DOI: 10.1517/14656566.9.12.2209.

3.Borg-Stein J, Simons DG. Focused review: myofascial pain[J]. Arch Phys Med Rehabil, 2002, 83(3 Suppl 1): S40-S49. DOI: 10.1053/apmr.2002.32155.

4.Littlejohn G. Regional pain syndrome: clinical characteristics, mechanisms and management[J]. Nat Clin Pract Rheumatol, 2007, 3(9): 504-511. DOI: 10.1038/ncprheum0598.

5.翟伟奇.替扎尼定治疗三叉神经痛有效性及安全性评析[J]. 中国卫生标准管理, 2015, 6(26): 83-85. [Zhai WQ. Efficacy and safety of tizanidine in the treatment of trigeminal neuralgia[J]. China Health Standard Management, 2015, 6(26): 83-85.] DOI: 10.3969/j.issn.1674-9316.2015.26.061.

6.Wagstaff AJ, Bryson HM. Tizanidine. A review of its pharmacology, clinical efficacy and tolerability in the management of spasticity associated with cerebral and spinal disorders[J]. Drugs, 1997, 53(3): 435-452. DOI: 10.2165/00003495-199753030-00007.

7.Tieu C, Breder CD. A Critical evaluation of safety signal analysis using algorithmic standardised MedDRA queries[J]. Drug Saf, 2018, 41(12): 1375-1385. DOI: 10.1007/s40264-018-0706-7.

8.张琪琳,丁玉峰,陈力,等. 基于FAERS对帕博利珠单抗和纳武利尤单抗不良事件的分析[J]. 中国药师, 2022, 25(8): 1384-1390. [Zhang QL, Ding YF, Chen L, et al. Analysis of the adverse events of pembrolizumab and nivolumab based on FAERS[J]. China Pharmacist, 2022, 25(8): 1384-1390.] DOI: 10.19962/j.cnki.issn1008-049X.2022.08.014.

9.Shu Y, He X, Liu Y, et al. Real-World disproportionality analysis of olaparib: data mining of the public version of FDA Adverse Event Reporting System[J]. Clin Epidemiol, 2022, 14: 789-802. DOI: 10.2147/CLEP.S365513.

10.Shu Y, Ding Y, Dai B, et al. A real-world pharmacovigilance study of axitinib: data mining of the public version of FDA adverse event reporting system[J]. Expert Opin Drug Saf, 2022, 21(4): 563-572. DOI: 10.1080/14740338.2022.2016696.

11.Villa-Zapata L, Gómez-Lumbreras A, Horn J, et al. A disproportionality analysis of drug-drug interactions of tizanidine and cyp1a2 inhibitors from the FDA Adverse Event Reporting System (FAERS)[J]. Drug Saf, 2022, 45(8): 863-871. DOI: 10.1007/s40264-022-01200-4.

12.American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults[J]. J Am Geriatr Soc, 2012, 60(4): 616-631. DOI: 10.1111/j.1532-5415.2012.03923.x.

13.董铎, 刘巍, 杨乐, 等. 欧盟药品不良反应管理和上报指南简介[J]. 中国药物警戒, 2014, 11(10): 611-613, 617. [Dong D, Liu W, Yang L, et al. European guidelines on the management and reporting of adverse drug reactions[J]. Chinese Journal of Pharmacovigilance, 2014, 11(10): 611-613, 617.] DOI: 10.19803/j.1672-8629. 2014.10.009.

14.U.S. Food and Drug Administration. Highlights of prescribing information[EB/OL]. (2013-10-04) [2023-01-01]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013101447s01110203975026161.pdf.

15.Dsouza L, Chaudhari P, Brahmam B, et al. Derma roller mediated transdermal delivery of tizanidine invasomes for the management of skeletal muscle spasms[J]. Eur J Pharm Sci, 2021, 165: 105920. DOI: 10.1016/j.ejps.2021.105920.

16.Saper JR, Lake AE 3rd, Cantrell DT, et al. Chronic daily headache prophylaxis with tizanidine: a double-blind, placebo-controlled, multicenter outcome study[J]. Headache, 2002, 42(6): 470-482. DOI: 10.1046/j.1526-4610.2002.02122.x.

17.Cortes J, Hall B, Redden D. Profound symptomatic bradycardia requiring transvenous pacing after a single dose of tizanidine [J]. J Emerg Med, 2015, 48(4): 458-460. DOI: 10.1016/j.jemermed.2014.10.005.

18.Wallace JD. Summary of combined clinical analysis of controlled clinical trials with tizanidine [J]. Neurology, 1994, 44(11 Suppl 9): S60-S69. https://pubmed.ncbi.nlm.nih.gov/7970013/.

19.Sklerov JH, Cox DE, Moore KA, et al. Tizanidine distribution in a postmortem case[J]. J Anal Toxicol, 2006, 30(5): 331-334. DOI: 10.1093/jat/30.5.331.

20.Brucculeri MJ, Garcia J. Potassium wasting nephropathy in the setting of tizanidine overdose: a case report[J]. J Med Case Rep, 2021, 15(1): 250. DOI: 10.1186/s13256-021-02811-8.