期刊
EXPERT OPINION ON DRUG SAFETY
卷 20, 期 11, 页码 1443-1450出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/14740338.2021.1956460
关键词
D-penicillamine; Wilson's disease; rheumatoid arthritis; cystinuria; pharmacovigilance analysis; FAERS
The study identified and analyzed adverse events associated with D-penicillamine, with findings showing a range of adverse reactions such as muscle spasm, drug hypersensitivity, blood cell abnormalities, joint swelling, renal impairment, swallowing difficulties, exacerbation of condition, congestive cardiac failure, peripheral edema, tremors, fever, and gait disturbances. Patients taking D-penicillamine require close monitoring due to the various potential adverse effects on renal, immune, liver, cardiac, and neurological functions.
Background D-penicillamine (D-pen) is a copper-chelating drug and has immune-modulatory properties. D-pen is used to treat rheumatoid arthritis, Wilson's disease, and kidney stones (cystinuria). However, associated adverse events (AEs) of D-pen treatment are frequent and often serious. Therefore, a comprehensive assessment of the safety profile of D-pen is urgently needed. Research design and methods We identified and analyzed AEs associated with D-pen between April-1970 to July-2020 from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) databases and calculated the reported odds ratio (ROR) with 95% confidence intervals (CI) using the disproportionality analysis. Results A total of 9,150,234 AEs related to drugs were reported in the FAERS database, of which 542 were related to D-Pen. We report that D-pen was associated with dystonia (ROR: 20.52; 95%CI: 12.46-33.80), drug hypersensitivity (ROR: 5.42; 95%CI: 3.72-7.90), pancytopenia (ROR: 10.20; 95%CI: 5.61-18.56), joint swelling (ROR: 9.07; 95%CI: 5.51-14.94), renal-impairment (ROR: 6.68; 95%CI: 3.67-12.15), dysphagia (ROR: 5.05; 95%CI: 2.76-8.89), aggravation of condition (ROR: 4.16; 95%CI: 2.60-6.67), congestive cardiac failure (ROR: 4.04; 95%CI: 2.22-7.35), peripheral edema (ROR: 3.77; 95%CI: 2.17-6.55), tremor (ROR: 3.46; 95%CI: 2.00-6.01), pyrexia (ROR: 3.46; 95%CI: 2.00-6.01), and gait disturbance (ROR: 2.41; 95%CI: 1.29-4.52). Conclusions Patients taking D-pen require close monitoring of renal function, blood counts, immunity, liver, cardiac function, and neurological function. D-pen suppresses immune system which maximizes the risk of infection.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据