Mining and analysis of Tolvaptan adverse reaction signal
ZHANG Ke1 WANG Jiao2 LI Bo1 SONG Yin1 YUAN Hengjie1 LI Zhengxiang
1.Department of Pharmacy,Tianjin Medical University General Hospital,Tianjin 300052,China;
2.Department of Pharmacy,Heping District Maternity Hospital,Tianjin 300052,China
Abstract：Objective To explore and analyze the safety signals of adverse reactions after the marketing of Tolvaptan,to provide evidence for clinical safe drug use.Methods The reporting odds ratio (ROR) method was used to mine the risk signals from the adverse reaction report data of Tolvaptan in the US Food and Drug Administration Public Data Open Project (OpenFDA) from May 19,2009 to December 25,2021.The reporting odds ratio (ROR) method was used to mine and analyze the data,and the results were classified according to systematic organ classification (SOC) and preferred term (PT).Results A total of 92 240 adverse reactions were reported during the retrieval period,of which 7816 were reported for Tolvaptan.A total of 49 risk signals of adverse reactions were obtained through analysis,among which sepsis (ROR=6.79),pneumonia (ROR=5.32) and fall (ROR=2.59) were not included in the manual.A total of 49 adverse reaction risk signals were analyzed in 12 systemic organs,including blood and lymphatic system diseases,infectious and infectious diseases,cardiovascular diseases,metabolic and nutritional disorders.Conclusion Through OpenFDA analysis,the signal intensity of adverse reactions after the marketing of Tolvaptan was obtained.In clinical use of Tolvaptan,close attention should be paid to its adverse reactions,especially to septicemia,pneumonia and fall,which are not included in the instructions,so as to avoid damage caused by them.
Corona G，Giuliani C，Parenti G.Moderate hyponatremia is associated with increased risk of mortality：evidence from a meta-analysis[J].PLoS One，2018，8（12）：e80451.
Mochizuki T，Muto S，Miyake M，et al.Safety and efficacy of Tolvaptan in real-world patients with autosomal dominant polycystic kidney disease- interim results of SLOWPKD surveillance[J].Clin Exp Nephrol，2021，25（11）：1-9.
[11]
Muto S，Kawano H，Higashihara E，et al.The effect of tolvaptan on autosomal dominant polycystic kidney disease patients：A subgroup analysis of the Japanese patient subset from TEMPO 3：4 trial[J].Clin Exp Nephrol，2015，19（5）：867-877.
Yuridullah R，Kumar V，Nanavati S，et al.Clinical Resolution of Osmotic Demyelination Syndrome following Overcorrection of Severe Hyponatremia[J].Case Rep Nephrol，2019，2019：1757656.
[19]
Shah P，Jacobs C，Ataya A.More haste，less speed：hyponatraemia and osmotic demyelination[J].Lancet，2018，392（10160）：2213.
[20]
Palamalai V，Olson APJ，Hogg JP，et al.Osmotic Demyelination Syndrome after Correction of Hyponatremia：A Case Report[J].J Appl Lab Med，2018，2（6）：965-969.
京公网安备 11010502046607号