Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FAERS database

Dong Boqing; Wang Jingwen; Bi Huanjing; Chen Zuhan; Lu Cuinan; Xue Wujun; Li Yang; Ding Xiaoming

doi:10.3969/j.issn.1674-7445.2024031

Volume 15 Issue 4

Jul. 2024

Turn off MathJax

Article Contents

Article Navigation > ORGAN TRANSPLANTATION > 2024 > 15(4): 581-590

Dong Boqing, Wang Jingwen, Bi Huanjing, et al. Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FAERS database[J]. ORGAN TRANSPLANTATION, 2024, 15(4): 581-590. doi: 10.3969/j.issn.1674-7445.2024031

Citation:

PDF( 4125 KB)

Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FAERS database

doi: 10.3969/j.issn.1674-7445.2024031

Department of Kidney Transplantation, the First Affiliated Hospital of Xi'an Jiaotong University, Institute of Organ Transplantation of Xi'an Jiaotong University, Xi'an 710061, China

More Information

Corresponding author: Ding Xiaoming, Email: xmding@xjtu.edu.cn
Received Date: 2024-01-23
Available Online: 2024-04-28
Publish Date: 2024-07-15

Abstract

Abstract

Objective To investigate the characteristics of adverse drug event (ADE) related to tacrolimus (Tac) in pediatric solid organ transplant recipients. Methods The data were retrieved from the US Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the second quarter of 2023. The ADE data of pediatric organ transplant recipients with Tac as the primary suspected drug were extracted. The relationship between Tac and ADE was quantitatively analyzed by proportional imbalance method. Basic characteristics and signal strength of ADE related to Tac were analyzed. ADE related to Tac in children of different ages and different types of organ transplantation were analyzed. Results A total of 1 443 children's ADE reports involving Tac were screened, including 188 cases (13.0%) of heart transplantation, 668 cases (46.3%) of liver transplantation, 531 cases (36.8%) of kidney transplantation and 56 cases (3.9%) of lung transplantation. The median age of children was 10 years old. The top three countries with ADE reporting were the United States, France and the United Kingdom. China reported 26 cases, accounting for 1.8%. Infection and infectious diseases accounted for the highest proportion (20.96%) in ADE related to Tac, including EB virus and cytomegalovirus infection, etc. Infection and infectious diseases occupied the largest proportion of ADE related to Tac in children of different ages, whereas the pathogen types were different. Rejection, unstable immunosuppression level and renal function damage were also common ADE related to Tac in children of all ages. Nervous system disease was the main ADE in heart transplant recipients, while infection and infectious diseases were more common in liver and kidney transplant recipients. Rejection was the most common ADE in lung transplant recipients. Conclusions ADE related to Tac possess different distribution characteristics in different types of organ transplantation. Extensive attention should be paid to individualized drug monitoring and risk assessment in pediatric organ transplant recipients, thereby optimizing Tac treatment and reducing the risk of ADE.
- Solid organ transplantation,
- Children,
- Tacrolimus,
- Adverse drug event,
- Infection,
- Rejection,
- Food allergy,
- Nervous system disease

FullText(HTML)

References(41)

References

[1]	JOHNSTON-WEBBER C, MAH J, PRIONAS A, et al. Solid organ donation and transplantation in the United Kingdom: good governance is key to success[J]. Transpl Int, 2023, 36: 11012. DOI: 10.3389/ti.2023.11012.
[2]	GEORGE M, THOMAS G, KARPELOWSKY J. Pediatric transplantation: an international perspective[J]. Semin Pediatr Surg, 2022, 31(3): 151192. DOI: 10.1016/j.sempedsurg.2022.151192.
[3]	SQUIRES JE, RAGHU VK, MAZARIEGOS GV. Optimizing the pediatric transplant candidate[J]. Curr Opin Organ Transplant, 2024, 29(1): 43-49. DOI: 10.1097/MOT.0000000000001115.
[4]	陈文倩, 张雷, 张弋, 等. 实体器官移植他克莫司个体化治疗专家共识[J]. 中国医院用药评价与分析, 2021, 21(12): 1409-1424. DOI: 10.14009/j.issn.1672-2124.2021.12.001. CHEN WQ, ZHANG L, ZHANG Y, et al. Expert consensus on individual treatment of tacrolimusin solid organ transplantation[J]. Eval Anal Drug-Use Hosp China, 2021, 21(12): 1409-1424. DOI: 10.14009/j.issn.1672-2124.2021.12.001.
[5]	KAMBARA H, OYAMA S, INADA A, et al. Current status of adverse event profile of tacrolimus in patients with solid organ transplantation from a pharmacovigilance study[J]. Int J Clin Pharmacol Ther, 2021, 59(12): 753-759. DOI: 10.5414/CP204016.
[6]	PIBURN KH, SIGURJONSDOTTIR VK, INDRIDASON OS, et al. Patterns in tacrolimus variability and association with de novo donor-specific antibody formation in pediatric kidney transplant recipients[J]. Clin J Am Soc Nephrol, 2022, 17(8): 1194-1203. DOI: 10.2215/CJN.16421221.
[7]	LIVERMAN R, CHANDRAN MM, CROWTHER B. Considerations and controversies of pharmacologic management of the pediatric kidney transplant recipient[J]. Pharmacotherapy, 2021, 41(1): 77-102. DOI: 10.1002/phar.2483.
[8]	MIN S, PAPAZ T, LAMBERT AN, et al. An integrated clinical and genetic prediction model for tacrolimus levels in pediatric solid organ transplant recipients[J]. Transplantation, 2022, 106(3): 597-606. DOI: 10.1097/TP.0000000000003700.
[9]	VAISBOURD Y, DAHHOU M, ZHANG X, et al. Differences in medication adherence by sex and organ type among adolescent and young adult solid organ transplant recipients[J]. Pediatr Transplant, 2023, 27(2): e14446. DOI: 10.1111/petr.14446.
[10]	PURPURA CA, GARRY EM, HONIG N, et al. The role of real-world evidence in FDA-approved new drug and biologics license applications[J]. Clin Pharmacol Ther, 2022, 111(1): 135-144. DOI: 10.1002/cpt.2474.
[11]	WU T, ZHANG Y, SHI Y, et al. Safety of glucagon-like peptide-1 receptor agonists: a real-world study based on the US FDA adverse event reporting system database[J]. Clin Drug Investig, 2022, 42(11): 965-975. DOI: 10.1007/s40261-022-01202-1.
[12]	NOWAK-WEGRZYN AH, SICHERER SH, CONOVER-WALKER MK, et al. Food allergy after pediatric organ transplantation with tacrolimus immunosuppression[J]. J Allergy Clin Immunol, 2001, 108(1): 146-147. DOI: 10.1067/mai.2001.116571.
[13]	ROBERTS AJ, LIM A, BISHOP JR, et al. Atopy and allergy following solid organ transplantation: a 15-year experience[J]. J Paediatr Child Health, 2023, 59(3): 537-541. DOI: 10.1111/jpc.16349.
[14]	GABE SM, BJARNASON I, TOLOU-GHAMARI Z, et al. The effect of tacrolimus (FK506) on intestinal barrier function and cellular energy production in humans[J]. Gastroenterology, 1998, 115(1): 67-74. DOI: 10.1016/s0016-5085(98)70366-x.
[15]	NEU J. Perinatal and neonatal manipulation of the intestinal microbiome: a note of caution[J]. Nutr Rev, 2007, 65(6 Pt 1): 282-285. DOI: 10.1301/nr.2007.jun.282-285.
[16]	CARDET JC, BOYCE JA. Addition of mycophenolate mofetil to tacrolimus is associated with decreases in food-specific IgE levels in a pediatric patient with liver transplantation-associated food allergy[J]. J Allergy Clin Immunol Pract, 2013(1): 104-106. DOI: 10.1016/j.jaip.2012.08.001.
[17]	STAATZ CE, TETT SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation[J]. Clin Pharmacokinet, 2004, 43(10): 623-653. DOI: 10.2165/00003088-200443100-00001.
[18]	SIMON AK, HOLLANDER GA, MCMICHAEL A. Evolution of the immune system in humans from infancy to old age[J]. Proc Biol Sci, 2015, 282(1821): 20143085. DOI: 10.1098/rspb.2014.3085.
[19]	ANGELICO R, ROMANO F, COPPOLA L, et al. Effects of anti-COVID-19 vaccination and pre-exposure prophylaxis with tixagevimab-cilgavimab in kidney and liver transplant recipients[J]. Medicina (Kaunas), 2023, 59(12): 2101. DOI: 10.3390/medicina59122101.
[20]	UDOMKARNJANANUN S, GATECHOMPOL S, LEELAHAVANICHKUL A, et al. Cellular immune response of SARS-CoV-2 vaccination in kidney transplant recipients: a systematic review and meta-analysis[J]. Front Immunol, 2023, 14: 1220148. DOI: 10.3389/fimmu.2023.1220148.
[21]	RODRIGUEZ-RODRIGUEZ AE, PORRINI E, TORRES A. Beta-cell dysfunction induced by tacrolimus: a way to explain type 2 diabetes?[J]. Int J Mol Sci, 2021, 22(19): 10311. DOI: 10.3390/ijms221910311.
[22]	GIULIANO K, CANNER JK, SCULLY BB, et al. Epstein-Barr virus predicts malignancy after pediatric heart transplant, induction therapy and tacrolimus don't[J]. Ann Thorac Surg, 2022, 114(5): 1794-1802. DOI: 10.1016/j.athoracsur.2021.08.038.
[23]	林芳, 沈茜, 徐虹, 等. 儿童肾移植术后淋巴组织增生性疾病两例报告暨文献复习[J]. 中华肾脏病杂志, 2021, 37(3): 183-190. DOI: 10.3760/cma.j.cn441217-20200613- 00029. LIN F, SHEN Q, XU H, et al. Post-transplantation lymphoproliferative disorders of kidney in children: two cases report and literature review[J]. Chin J Nephrol, 2021, 37(3): 183-190. DOI: 10.3760/cma.j.cn441217-20200613-00029.
[24]	赵升桥, 孙超. 儿童肝移植术后EB病毒相关淋巴组织增生性疾病的诊治进展[J]. 临床小儿外科杂志, 2023, 22(1): 79-83. DOI: 10.3760/cma.j.cn101785-202203015-015. ZHAO SQ, SUN C. Advances in the diagnosis and treatment of EBV associated lymphoproliferative disease in pediatric liver transplant recipients[J]. J Clin Pediatr Surg, 2023, 22(1): 79-83. DOI: 10.3760/cma.j.cn101785-202203015-015.
[25]	AHLENSTIEL-GRUNOW T, PAPE L. Virus-specific T cells in pediatric renal transplantation[J]. Pediatr Nephrol, 2021, 36(4): 789-796. DOI: 10.1007/s00467-020-04522-6.
[26]	闫勇闯, 王志刚, 齐元博, 等. 学龄后儿童肾移植后BK多瘤病毒感染的影响因素及其预测模型构建[J]. 中华医学杂志, 2023, 103(20): 1538-1545. DOI: 10.3760/cma.j.cn112137-20230105-00021. YAN YC, WANG ZG, QI YB, et al. Factors affecting BK polyomavirus infection after kidney transplantation in post-school children and a predictive infection model[J]. Natl Med J China, 2023, 103(20): 1538-1545. DOI: 10.3760/cma.j.cn112137-20230105-00021.
[27]	CHEN X, WANG D, ZHENG F, et al. Population pharmacokinetics and initial dose optimization of tacrolimus in children with severe combined immunodeficiency undergoing hematopoietic stem cell transplantation[J]. Front Pharmacol, 2022, 13: 869939. DOI: 10.3389/fphar.2022.869939.
[28]	SCHAGEN MR, VOLAREVIC H, FRANCKE MI, et al. Individualized dosing algorithms for tacrolimus in kidney transplant recipients: current status and unmet needs[J]. Expert Opin Drug Metab Toxicol, 2023, 19(7): 429-445. DOI: 10.1080/17425255.2023.2250251.
[29]	DUNCAN-PARK S, DANZIGER-ISAKOV L, ARMSTRONG B, et al. Posttraumatic stress and medication adherence in pediatric transplant recipients[J]. Am J Transplant, 2022, 22(3): 937-946. DOI: 10.1111/ajt.16896.
[30]	RATHGEBER SL, HUTCHISON SM, DE SOUZA AM, et al. A text messaging intervention and quality of life in adolescents with solid organ transplants[J]. Pediatr Transplant, 2022, 26(3): e14219. DOI: 10.1111/petr.14219.
[31]	BRAITHWAITE HE, DARLEY DR, BRETT J, et al. Identifying the association between tacrolimus exposure and toxicity in heart and lung transplant recipients: a systematic review[J]. Transplant Rev (Orlando), 2021, 35(2): 100610. DOI: 10.1016/j.trre.2021.100610.
[32]	符晓娜, 张丽, 汪晶. 心脏移植术后中枢神经系统并发症的影像学表现[J]. 器官移植, 2022, 13(5): 672-677. DOI: 10.3969/j.issn.1674-7445.2022.05.019. FU XN, ZHANG L, WANG J. Imaging manifestations of central nervous system complications after heart transplantation[J]. Organ Transplant, 2022, 13(5): 672-677. DOI: 10.3969/j.issn.1674-7445.2022.05.019.
[33]	DEMIRALP G, ARRIGO RT, CASSARA C, et al. Heart transplantation-postoperative considerations[J]. Crit Care Clin, 2024, 40(1): 137-157. DOI: 10.1016/j.ccc.2023.05.004.
[34]	HINCHEY J, CHAVES C, APPIGNANI B, et al. A reversible posterior leukoencephalopathy syndrome[J]. N Engl J Med, 1996, 334(8): 494-500. DOI: 10.1056/NEJM199602223340803.
[35]	JEELANI H, SHARMA A, HALAWA AM. Posterior reversible encephalopathy syndrome in organ transplantation[J]. Exp Clin Transplant, 2022, 20(7): 642-648. DOI: 10.6002/ect.2021.0268.
[36]	LI Y, SONG J, HUQ AM , et al. Posterior reversible encephalopathy syndrome and autoimmunity[J]. Autoimmun Rev, 2023, 22(2): 103239. DOI: 10.1016/j.autrev.2022.103239.
[37]	KARATAŞ C, AKYOLLU B, ARPALI E, et al. Should calcineurin inhibitors/sirolimus be ceased completely in posterior reversible encephalopathy syndrome?[J]. Transplant Proc, 2024, 56(1): 93-96. DOI: 10.1016/j.transproceed.2023.11.012.
[38]	NEUROHR C, HUPPMANN P, ZIMMERMANN G, et al. Tacrolimus and mycophenolate mofetil as first line immunosuppression after lung transplantation[J]. Transpl Int, 2009, 22(6): 635-643. DOI: 10.1111/j.1432-2277.2009.00843.x.
[39]	IVULICH S, DOOLEY M, KIRKPATRICK C, et al. Clinical challenges of tacrolimus for maintenance immunosuppression post-lung transplantation[J]. Transplant Proc, 2017, 49(9): 2153-2160. DOI: 10.1016/j.transproceed.2017.07.013.
[40]	HUANG X, HAPGOOD K, ALLAN K, et al. Extended-release tacrolimus dosing and outcomes in pediatric and young adult transplant recipients - a single-center experience[J]. Pediatr Transplant, 2024, 28(1): e14611. DOI: 10.1111/petr.14611.
[41]	BUDDE K, ROSTAING L, MAGGIORE U, et al. Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe[J]. Transpl Int, 2022, 35: 10225. DOI: 10.3389/ti.2021.10225.

Relative Articles

Supplements(0)

Cited By

Proportional views

Proportional views

通讯作者: 陈斌, bchen63@163.com

1.
沈阳化工大学材料科学与工程学院沈阳 110142

Figures(5) / Tables(4)

Get Citation

PDF

XML

Article Metrics

Article views (83) PDF downloads(5)

Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FAERS database

doi: 10.3969/j.issn.1674-7445.2024031

Abstract

References

Proportional views

Catalog

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Proportional views

Related

Study of adverse drug events related to tacrolimus in pediatric solid organ transplant recipients based on FAERS database

doi: 10.3969/j.issn.1674-7445.2024031

Abstract

References

Proportional views

Catalog

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Proportional views

Related

Export File

Citation

Format

Content