scholarly journals Acute Kidney Injury and Bisphosphonate Use in Cancer: A Report From the Research on Adverse Drug Events and Reports (RADAR) Project

2013 ◽  
Vol 9 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Beatrice J. Edwards ◽  
Sarah Usmani ◽  
Dennis W. Raisch ◽  
June M. McKoy ◽  
Athena T. Samaras ◽  
...  

Analysis of bisphosphonate-associated acute kidney injury reports for cancer cases within FDA's Adverse Events and Reporting System failed to demonstrate a significant safety signal, an unexpected finding given prior preclinical and clinical findings that suggested a causal association between BPs and AKI.

2011 ◽  
Vol 9 (3) ◽  
pp. 265-282 ◽  
Author(s):  
Diogo Diniz Gomes Bugano ◽  
Alexandre Biasi Cavalcanti ◽  
Anderson Roman Goncalves ◽  
Claudia Salvini de Almeida ◽  
Eliézer Silva

ABSTRACT Objective: To compare efficacy and safety of vancomycin versus teicoplanin in patients with proven or suspected infection. Methods: Data Sources: Cochrane Renal Group's Specialized Register, CENTRAL, MEDLINE, EMBASE, nephrology textbooks and review articles. Inclusion criteria: Randomized controlled trials in any language comparing teicoplanin to vancomycin for patients with proven or suspected infection. Data extraction: Two authors independently evaluated methodological quality and extracted data. Study investigators were contacted for unpublished information. A random effect model was used to estimate the pooled risk ratio (RR) with 95% confidence interval (CI). Results: A total of 24 studies (2,610 patients) were included. The drugs had similar rates of clinical cure (RR: 1.03; 95%CI: 0.98-1.08), microbiological cure (RR: 0.98; 95%CI: 0.93-1.03) and mortality (RR: 1.02; 95%CI: 0.79-1.30). Teicoplanin had lower rates of skin rash (RR: 0.57; 95%CI: 0.35-0.92), red man syndrome (RR: 0.21; 95%CI: 0.08-0.59) and total adverse events (RR: 0.73; 95%CI: 0.53-1.00). Teicoplanin reduced the risk of nephrotoxicity (RR: 0.66; 95%CI: 0.48-0.90). This effect was consistent for patients receiving aminoglycosides (RR: 0.51; 95%CI: 0.30-0.88) or having vancomycin doses corrected by serum levels (RR: 0.22; 95%CI: 0.10-0.52). There were no cases of acute kidney injury needing dialysis. Limitations: Studies lacked a standardized definition for nephrotoxicity. Conclusions: Teicoplanin and vancomycin are equally effective; however the incidence of nephrotoxicity and other adverse events was lower with teicoplanin. It may be reasonable to consider teicoplanin for patients at higher risk for acute kidney injury.


2021 ◽  
Vol 61 (2) ◽  
pp. 115-8
Author(s):  
Tahmina Khandkar ◽  
Amina Akter ◽  
Asaduzzaman Asaduzzaman ◽  
Ranjit Ranjan Roy ◽  
Golam Muinuddin

The skin is the most commonly affected organ. Wasp venom causes both local and systemic reactions, but acute kidney injury (AKI) is the most serious complication, with a 20% mortality rate. Acute kidney injury can occur from single or multiple stings. Diagnosis depends on history, clinical findings, and investigations. Treatment protocol is same as other causes of AKI, including dialysis, and prognosis is good with early treatment.


2019 ◽  
Vol 44 (3) ◽  
pp. 415-425
Author(s):  
Miaolin Che ◽  
Xudong Wang ◽  
Bo Xie ◽  
Ritai Huang ◽  
Shang Liu ◽  
...  

Background/Aims: Cardiac surgery-associated acute kidney injury (CSA-AKI) was traditionally defined as an increase in serum creatinine (sCr) after cardiac surgery. Recently, serum cystatin C (sCyC) has been proposed to be a better biomarker in the prediction of AKI. The clinical utility and performance of combining sCyC and sCr in patients with AKI, particularly for the prediction of long-term outcomes, remain unknown. Methods: We measured sCyC together with sCr in 628 patients undergoing cardiac surgery. sCyC and sCr were assessed at baseline and 24 and 48 h after surgery. CSA-AKI determined by sCr (CSA-AKIsCr) was defined as an sCr increase greater than 0.3 mg/dL or 50% from baseline. Major adverse events (MAEs; including death of any cause and dialysis) at 3 years were assessed. Results: CSA-AKIsCr developed in 178 patients (28.3%). Three-year follow-up was available for 621 patients; MAEs occurred in 42 patients (6.8%). An increase in sCyC concentration ≥30% within 48 h after surgery was detected in 228 patients (36.3%). This was the best sCyC cutoff for CSA-AKIsCr detection (negative predictive value = 88.8%, positive predictive value = 58.3%). To evaluate the use of both sCyC and sCr as CSA-AKI diagnostic criteria, we stratified patients into 3 groups: non-CSA-AKI, CSA-AKI detected by a single marker, and CSA-AKI detected by both markers. By multivariable logistic regression analysis, the independent predictors of MAEs at 3 years were group 2 (non-CSA-AKI group as the reference, CSA-AKI detected by a single marker: odds ratio [OR] = 3.48, 95% confidence interval [CI]: 1.27–9.58, p = 0.016), group 3 (CSA-AKI detected by both markers: OR = 5.12, 95% CI: 2.01–13.09; p = 0.001), and baseline glomerular filtration rate (OR = 2.24; 95% CI: 1.27–3.95; p = 0.005). Conclusion: Combining sCyC and sCr to diagnose CSA-AKI would be beneficial for risk stratification and prognosis in patients after cardiac surgery.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S662-S662
Author(s):  
Taylor M Patek ◽  
Chengwen Teng ◽  
Kaitlin E Kennedy ◽  
Christopher R Frei

Abstract Background A recent article published in 2018 studied the FDA Adverse Event Reporting System (FAERS) and listed the most common medications associated with acute kidney injury (AKI) based on number of AKI reports. In regards to antibiotics, the study only ranked vancomycin, fluoroquinolones, penicillin combinations, and trimethoprim–sulfamethoxazole as having a significant association with AKI. The objective of this study was to evaluate those and additional antibiotic classes using FAERS, and to compare their risk associated with this adverse drug event. Methods FAERS reports from January 1, 2015 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify AKI cases. Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and AKI were calculated. An association was considered statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 2,042,801 reports (including 20,138 acute kidney injury reports) were considered, after inclusion criteria were applied. Colistin had the greatest proportion of AKI reports, representing 25% of all colistin reports. Acute kidney injury RORs (95% CI) for antibiotics were (in descending order): colistin 33.10 (21.24–51.56), aminoglycosides 17.41 (14.49–20.90), vancomycin 15.28 (13.82–16.90), trimethoprim-sulfamethoxazole 13.72 (11.94–15.76), penicillin combinations 7.95 (7.09–8.91), clindamycin 6.46 (5.18–8.04), cephalosporins 6.07 (5.23–7.05), daptomycin 6.07 (4.61–7.99), macrolides 3.60 (3.04–4.26), linezolid 3.48 (2.54–4.77), carbapenems 3.31 (2.58–4.25), metronidazole 2.55 (1.94–3.36), tetracyclines 1.73 (1.26–2.36), and fluoroquinolones 1.71 (1.49–1.97). Conclusion This study found 17 classes of antibiotics and combinations that were significantly associated with AKI compared with four antibiotics that were mentioned in a recently published article looking at drug-associated AKI. While this study confirmed previous literature of certain antibiotics associated with increased risk of AKI, it also compared antibiotics within classes and provided additional insight regarding which antibiotics had the highest associated risk of an AKI. Disclosures All authors: No reported disclosures.


2019 ◽  
Vol 12 (10) ◽  
pp. e231211 ◽  
Author(s):  
Lexis Gordon ◽  
Pouneh Dokouhaki ◽  
Kimberly Hagel ◽  
Bhanu Prasad

Immune checkpoint inhibitors are novel oncological medications, current classes of which include monoclonal antibodies that target inhibitory receptors cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), programmed death 1 protein (PD-1) and programmed death-ligand 1. While they are novel in their ability to treat cancer, they also have a unique spectrum of immune-related adverse events. Renal-related immune adverse events, though rare, are an increasingly recognised clinical entity. We present the case of a 67-year-old man with acute kidney injury (AKI) after the second cycle of combination anti-CTLA-4 and anti-PD-1 antibodies for metastatic cutaneous melanoma. He presented with vomiting and diarrhoea, and AKI secondary to dehydration was treated with aggressive rehydration. After failing to recover biochemically, a renal biopsy was performed, which demonstrated severe acute interstitial nephritis. The culprit medications were held and he was treated with steroids. With immunosuppression, creatinine improved to pretreatment values.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4063-4063
Author(s):  
Beatrice J. Edwards ◽  
Beatrice Nardone ◽  
Dennis W Raisch ◽  
June M. Mckoy ◽  
Steven M Belknap ◽  
...  

4063 Background: In 2009, the US Food and Drug Administration (FDA) reported on 23 patients who had developed distal esophageal cancer, with alendronate (ALN) within 2 years of initiation of therapy. Similarly, 31 cases of esophageal cancer were reported from Europe and Japan. Esophagitis has been associated with oral BPs. Erosive esophagitis and persistent mucosal abnormalities have been noted with crystalline material (similar to ground ALN). Our objective was to assess the FDA Adverse event reporting system (FDA AERS) for a safety signal. Methods: The FDA Adverse Event Reporting System (AERS) database was searched using terms related to esophageal cancer combined with all drug names for bisphosphonates (search period:1996-2010). Disproportionality ratios were calculated: Proportional reporting ratio (PRR) and Empiric Bayes Geometric Mean (EBGM) determining that the esophageal cancer cases were more common with bisphosphonates than with other drugs in the database. Results: We identified 128 cases of bisphosphonate-associated esophageal cancer; 114 (89%) female and 14 male (11%), mean age 72 ± 12 yrs; the drugs included alendronate (n=96, 75%), risedronate sodium (n=14, 11%), ibandronic acid (n=10, 7.8%), zoledronic acid (n=7, 5.4%) and pamidronate (n=1, 1%). Barrett’s esophagus was listed in 3 cases of esophageal carcinoma. A significant safety signal was found only for alendronate with a PRR= 6.4 (95% C.I. 5.29, 7.730; p=0.001), EBGM = 6.3 (95% C.I. 5.1, 7.6 p=0.001). Conclusions: Our analysis of FDA AERS identifies a larger number of cases of esophageal cancer than previously described, and a significant safety signal with alendronate use. Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, and persistent mucosal abnormalities is recommended. Increased awareness and vigilance is needed for patients receiving oral bisphosphonate therapy.


2021 ◽  
Vol 45 ◽  
Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Alexis Pillsbury ◽  
Catherine Glover ◽  
...  

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2019 reported to the Therapeutic Goods Administration (TGA) and describes reporting trends over the 20-year period from 1 January 2000 to 31 December 2019. There were 3,782 AEFI records for vaccines administered in 2019, an annual AEFI reporting rate of 14.9 per 100,000 population. There was an 11.8% decrease in the overall AEFI reporting rate in 2019 compared to 2018 (16.9 per 100,000 population). This decrease in the AEFI reporting rate in 2019 was mainly attributable to a decline in reported adverse events related to the human papillomavirus (HPV), dTpa, meningococcal ACWY and seasonal influenza vaccines. AEFI reporting rates for most individual vaccines in 2019 were similar to 2018. The most commonly-reported adverse events were injection site reaction (35.8%), rash (16.6%), pyrexia (15.3%), vomiting (8.1%), urticaria (5.8%), pain (5.8%) and headache (5.7%). There were five deaths reported to the TGA. In one report, the timing and clinical findings were consistent with a causal association with vaccination. In the remaining four reports, no clear causal relationship with vaccination was found.


2020 ◽  
Vol 18 (3) ◽  
pp. 2024
Author(s):  
Kerri A. McGrady ◽  
Makenzie Benton ◽  
Serina Tart ◽  
Riley Bowers

Background: Area under the curve to minimum inhibitory concentration (AUC/MIC) has been recommended by the 2020 updated vancomycin guidelines for dosing vancomycin for both efficacy and safety. Previously, AUC/MIC has been cumbersome to calculate so surrogate trough concentrations of 15-20 mg/dL were utilized. However, trough-based dosing is not a sufficient surrogate as AUC/MIC targets of 400-600 can usually be reached without achieving troughs of 15-20 mg/dL. Targeting higher trough levels may also lead to adverse events including acute kidney injury (AKI) and nephrotoxicity. Objective: To compare the mean total first day vancomycin dose in traditional trough-based dosing versus dosing recommended by an AUC/MIC dosing program. Methods: Adult inpatients who received at least 24 hours of IV vancomycin treatment were included in this single-center, retrospective cohort study. The primary endpoint was difference in mean total first day vancomycin dose in milligrams (mg) received between patients’ traditional trough-based dosing and recommended dose via AUC/MIC electronic dosing calculator. Patients served as their own control by analyzing both actual dose received and dose recommended by the electronic AUC/MIC program. Rates of vancomycin induced adverse events, including acute kidney injury, elevated steady-state trough concentrations, and Red Man’s syndrome were also compared between patients who received doses consistent with the AUC/MIC dosing recommendation versus those who did not. Results: 264 patients were included in this study. Initial 24-hour vancomycin exposure was significantly lower with the recommended AUC/MIC dose versus the dose received (2380.7; SD 966.6 mg vs 2649.6; SD 831.8 mg, [95% CI 114.7:423.1] p=0.0007). Conclusions: Utilizing an electronic AUC/MIC vancomycin dosing calculator would result in lower total first day vancomycin doses.


Author(s):  
Katsuhiro Matsuura ◽  
Tomohiko Yoshida ◽  
Takuya Uehara ◽  
Shusaku Yamada ◽  
Hideki Yotsuida ◽  
...  

Abstract CASE DESCRIPTION An 11-year-old sexually intact male Shih Tzu diagnosed with acute kidney injury and left-sided congestive heart failure that had nonelective mitral valve surgery. CLINICAL FINDINGS Metabolic alkalosis developed postoperatively, and plasma bicarbonate concentration peaked 2 days after surgery (40.2 mmol/L; pH, 7.550). TREATMENT AND OUTCOME Acetazolamide administration increased the urinary excretion of bicarbonate and contributed to the improvement of the dog’s acid-base status and oxygenation capacity. Metabolic alkalosis persisted for 4 days after surgery, and no treatment was required after resolution. Plasma urea nitrogen and creatinine concentrations normalized 2 days after surgery. CLINICAL RELEVANCE Severe metabolic alkalosis can occur as a complication following mitral valve surgery. Acetazolamide may be suitable for the treatment of severe metabolic alkalosis.


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