scholarly journals Pharmacovigilance of Sodium-Glucose Cotransporter-2 Inhibitors for Genital Fungal Infections and Urinary Tract Infections: A Review of the Food and Drug Administration Adverse Event Reporting System Database

2018 ◽  
Vol 34 (4) ◽  
pp. 144-148
Author(s):  
Hannah Mohammad ◽  
Nancy Borja-Hart
Keyword(s):  
Urinary Tract ◽  
Tract Infection ◽  
Adverse Events ◽  
Fungal Infections ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sglt2 Inhibitors ◽  
Postmarketing Surveillance ◽  
Sodium Glucose Cotransporter ◽  
Tract Infections

Background: Postmarketing surveillance had previously identified the need for revisions in the labeling of the sodium-glucose cotransporter-2 (SGLT2) inhibitors drug class related to the risk of diabetic ketoacidosis. Other adverse events have been reported. Objective: To examine postmarketing surveillance data of the SGLT2 inhibitors, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically to assess prevalence of urinary tract infections (UTIs) and genital fungal infections. Methods: FAERS case reports submitted between March 2013 and November 2015 were reviewed for 6 SGLT2 inhibitors (mono and combo therapies). The Medical Dictionary for Regulatory Activities (MedDRA) was used to define preferred terms (genital fungal infections: vulvovaginal mycotic infection, vulvovaginal candidiasis, urinary tract infection fungal, and genital candidiasis; UTI: urinary tract infection, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis). Word frequencies were queried using the qualitative data analysis software NVivo 11 (QSR International), and results were then individually reviewed. Results: A total of 12 581 cases were received, but 466 were excluded (total n = 12 115). A total of 348 cases related to genital fungal infections were reported (2.9% of reports submitted): dapagliflozin = 53, empagliflozin/linagliptin = 6, canagliflozin = 267, canagliflozin/metformin = 3, empagliflozin = 17, and dapagliflozin/metformin HCl ER = 2. A total of 727 cases related to UTIs were reported (6% of reports submitted): dapagliflozin = 168, empagliflozin/linagliptin = 5, canagliflozin/metformin = 8, canagliflozin = 503, empagliflozin = 38, and dapagliflozin/metformin HCl ER = 5. Conclusions: A causal relationship between SGLT2 inhibitors and the adverse events reported cannot be established due to the nature of postmarketing surveillance. However, health care providers should counsel patients about these potential adverse events.

Genito-urinary fungal infections

2017 ◽  
Author(s):  
Jack D. Sobel
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Genital Tract ◽  
Fungal Infections ◽  
Fungal Species ◽  
Clinical Expression ◽  
Lower Genital Tract ◽  
Tract Infections ◽  
Made In

The predominant fungal causes of genitourinary disease are Candida spp.; other fungal genera are uncommon pathogens in both sexes. Vulvovaginal candidiasis affects millions of women worldwide—and includes acute sporadic, recurrent, and chronic syndromes—and considerable progress has been made in understanding its pathophysiology and hence the best therapy. Therapeutic options are still limited, however, and misdiagnosis is common. In contrast, urinary tract candidiasis reflects an entirely different pathogenesis and clinical expression affecting a predominantly hospital-based older population. Candida organisms are extremely difficult to eradicate from often complicated urinary tract infections. Non-Candida fungal species reach the kidney and prostate by the bloodstream rather than the ascending route taken by Candida spp. In women, not infrequently, there is simultaneous lower genital tract and urinary tract infection, requiring attention to both systems.

scholarly journals Sodium-glucose cotransporter-2 inhibitors and risk for genitourinary infections in older adults with type 2 diabetes

2021 ◽  
Vol 12 ◽  
pp. 204209862199770
Author(s):  
Navya Varshney ◽  
Sarah J. Billups ◽  
Joseph J. Saseen ◽  
Cy W. Fixen
Keyword(s):  
Type 2 Diabetes ◽  
Older Adults ◽  
Urinary Tract ◽  
Real World ◽  
Fungal Infections ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
Significant Difference ◽  
Tract Infections

Background and aims: Although landmark clinical trials have demonstrated an increased risk for genitourinary infection (GUI) after initiation of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy that led to an FDA label warning, real world findings have been inconsistent and evidence specifically in older adults is lacking. The objective of the study was to examine the incidence of GUI in patients aged 65 years or older initiated on SGLT2i compared with glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy at a large academic health system. Methods: A retrospective population-based cohort study was conducted using electronic health records of patients aged 65 years and older with a diagnosis of type 2 diabetes mellitus. Patients newly initiated on SGLT2i or GLP1-RA therapy with estimated glomerular filtration rate (eGFR) ⩾30 mL/min per 1.73 m² and active within the health system for at least 1 year prior to initiation were included. We compared the incidence of inpatient, emergency room, or outpatient diagnosis of GUI (bacterial and mycotic) within 6 months of SGLT2i or GLP1-RA initiation. A chi-square or Fisher’s exact test were used to analyze between-group differences for categorical variables, while a t-test was used for continuous variables. A Cox proportional hazards model was used to estimate the impact of confounding variables on the primary outcome. Results: One hundred and thirty-three patients were initiated on SGLT2i therapy and 341 patients newly initiated on GLP1-RA therapy. After adjusting for differences in age, A1c, body mass index, eGFR, race and sex, there was no statistically significant difference in GUI incidence within 6 months of SGLT2i versus GLP1-RA initiation (3.8% versus 6.5%, adjusted hazard ratio: 0.784, 95% confidence interval 0.260–2.367). Conclusion: We found no increased risk of composite GUI within 6 months of initiating SGLT2i compared with GLP1-RA therapy. These real-world data in older adults add to previous findings, which suggest no increased risk of urinary tract infection with SGLT2i initiation. Plain language summary A class of antidiabetic medications and risk for genitourinary infections in older adults with type 2 diabetes Older adults with type 2 diabetes often benefit from a class of antidiabetic medications known as sodium-glucose cotransporter-2 inhibitors (SGLT2is) which help to lower blood glucose, decrease risk for cardiovascular disease and prevent kidney disease progression. However, there is concern that these medications may increase risk for urinary tract infections and/or genital fungal infections in older adults based on clinical trial evidence. Our study evaluated the real-world occurrence of these safety events in patients aged 65 years or older who were newly started on these medications. We compared these patients with a group of patients newly started on an alternative class of antidiabetic agents which are not expected to increase risk for infections, known as glucagon-like peptide-1 receptor agonists (GLP1-RA). In our study, we included 133 patients who started an SGLT2i and 341 patients who started a GLP1-RA at a large teaching hospital. We evaluated the occurrence of infection up to 6 months after initiation of these mediations. We found no significant difference in infection rate between these two groups. We conclude in the study that the use of SGLT2i in older adults was not associated with increased risk for urinary tract infections or genital fungal infections when compared with GLP1-RA use.

scholarly journals Risk factors of the fungal urinary tract infections

2021 ◽  
pp. 178-184
Author(s):  
N. V. Sturov ◽  
S. V. Popov ◽  
I. Yu. Shmelkov
Keyword(s):  
Risk Factors ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Urinary Tract Infections ◽  
Fungal Infections ◽  
Antifungal Drugs ◽  
Main Role ◽  
Tract Infections

The role of fungi as causative agents of infections is growing. In in-patients, especially at intensive care units, fungal infections might cause serious problems. Studies conducted over recent years shows an increase of fungi detection in urine in in-patients from 5,01 up to 10,63%. Most often, the appearance of fungi in the urine connected with contamination or colonization of the urinary tract. However, in immunocompromised patients, this could be the part of urinary tract infection and even of disseminated fungal process. Candida is the most common cause of fungal urinary tract infections. At the same time, the presence of Candida in urine (candiduria) not always comes with clinical signs of urethritis, cystitis and pyelonephritis. Detection of noCandida albicans agents in urine is increasing, new Candida species revealed are resistant to antifungal drugs so risk of complications is increasing. Recent researches reveal new mechanisms of how Candida interacts with the bacteria that cause urinary infections. The main mechanisms of Candida virulence factors are dimorphism, adhesion proteins — Als1-7,9 and Gls, invasion enzymes — phospholipase, Als3 and Ssa1, as well as enzymes that neutralize reactive oxygen species. The most significant risk factors of fungal urinary tract infection are the presence of a urinary catheter, diabetes mellitus, immunosuppression and previous antibiotic intake. The study of the formation process of the cellular and immune response to Candida makes it possible to identify the main links in the pathogenesis of urinary tract candidiasis, as well as the main role of immunosuppression in the development of the disease.

scholarly journals Efficacy and safety of quinolones for the treatment of uncomplicated urinary tract infections in women: a network meta-analysis

2019 ◽  
Author(s):  
Alejandro G Gonzalez-Garay ◽  
Liliana Velasco-Hidalgo ◽  
Eric Ochoa-Hein ◽  
Roberto Rivera-Luna
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Adverse Events ◽  
Treatment Duration ◽  
Meta Analysis ◽  
Uncomplicated Urinary Tract Infection ◽  
Efficacy And Safety ◽  
Menopausal Women ◽  
Tract Infections

Abstract Background Uncomplicated urinary tract infection is considered an infection that occurs in healthy individuals who have a normal urinary tract, representing 5% of all annual medical visits. Several quinolones are available as second-line agents for treatment; however, we do not know which is the best antibiotic scheme for urinary tract infection; therefore, we conducted a network meta-analysis to hierarchize each quinolone according to its efficacy and safety. Methods MEDLINE, EMBASE and other databases were subjected to non-language-restricted searches up to 2018 for trials that included women treated with quinolones for uncomplicated urinary tract infection. Bias in the trials was assessed by two reviewers; the Cochrane Collaboration tool was used to analyze clinical and bacteriological remission, relapse, resistance, and adverse events. For direct comparisons, we obtained risk ratios and 95% confidence intervals by applying a fixed events model using Tau2 and Q2 tests to calculate the heterogeneity using trimethoprim/sulfamethoxazole as the common comparator across studies. For the network meta-analysis, we analyzed the indirect comparisons by Bucher's method. The results were summarized in a correlation matrix. Results We included 18 trials with 8765 women. For pre-menopausal women and treatment duration <3 days, norfloxacin and ofloxacin had a 57% of probability for achieving remission but with an 83% frequency of adverse events. For post-menopausal women, ciprofloxacin and ofloxacin were 82% more effective for remission with an 49% frequency of adverse events compared with other types of quinolones. Conclusions Compared with other quinolones, ofloxacin (200 mg) was more effective for remission, although with a high probability of adverse events; however, norfloxacin (400 mg) could be an alternative in treatment, due to it low probability of adverse events; even though additional trials are needed to confirm our findings, especially in treatment duration exceeds 3 days. PROSPERO registration CRD42015025886

scholarly journals Fournier Gangrene Associated with Sodium-Glucose Cotransporter-2 Inhibitors: A Pharmacovigilance Study with Data from the U.S. FDA Adverse Event Reporting System

2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Yang Hu ◽  
Ziyu Bai ◽  
Yan Tang ◽  
Rongji Liu ◽  
Bin Zhao ◽  
...  
Keyword(s):  
Adverse Event ◽  
Clinical Practice ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Sglt2 Inhibitor ◽  
Sglt2 Inhibitors ◽  
Fournier Gangrene ◽  
Sodium Glucose Cotransporter ◽  
The U.S

Background. The U.S. Food and Drug Administration (FDA) released a safety warning of Fournier gangrene (FG), a rare but serious adverse effect of sodium-glucose cotransporter-2 (SGLT2) inhibitors in August 2018. However, existing studies have focused mainly on individual FG case reports. Although several previous studies conducted reviews of cases, objective scientific analysis was not applied, and the prognosis data were inadequate. Objective. This study is aimed at presenting data supplementary to existing studies by analysing postmarketing adverse event reports in the FDA Adverse Events Reporting System (FAERS) database. Multiple statistical analysis methods were applied to evaluate the potential association between SGLT2 inhibitors and FG, thus providing reliable and professionalized medication usage recommendations for SGLT2 inhibitors in clinical practice. Methods. Disproportionality analysis and Bayesian analysis were applied for data mining among the suspected adverse event reports of FG associated with SGLT2 inhibitors recorded in the FAERS database during the period from January 2004 to September 2019. Results. There were 542 FG cases identified in the FAERS database in patients receiving SGLT2 inhibitors. Among all SGLT2 inhibitor therapies, empagliflozin was associated with the highest number of FG reports (232 in total), while empagliflozin plus metformin had the strongest association with FG occurrence with the reporting odds ratio (ROR 54.79, 95% two-sided CI 31.56 to 95.12) and proportional reporting ratio (PRR 53.36, χ2 666.70). There were 391 patients who underwent initial or prolonged hospitalization (72.14%), and 26 patients died (4.81%). Three new FG cases caused by ertugliflozin were found in 2019. Conclusion. The analysis of SGLT2 inhibitor-associated FG reports in the FAERS database identified signals between the drug and adverse events of interest. It also provides comprehensive information on the characteristics of FG onset and prognosis. Clinicians should pay more attention to this rare but severe adverse event when prescribing SGLT2 inhibitors in clinical practice.

A Case of Septic Shock Due to Serratia marcescens Pyelonephritis and Bacteremia in a Patient Receiving Empagliflozin

2016 ◽  
Vol 30 (6) ◽  
pp. 672-675 ◽  
Author(s):  
Wesley D. Kufel ◽  
Ali Scrimenti ◽  
Jeffrey M. Steele
Keyword(s):  
Septic Shock ◽  
Serratia Marcescens ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Sodium Glucose Cotransporter ◽  
Intravenous Antibiotics ◽  
Tract Infections ◽  
Oral Ciprofloxacin ◽  
Type 2 Diabetic

Sodium–glucose cotransporter 2 (SGLT2) inhibitors have been associated with serious urinary tract infections (UTIs) including pyelonephritis and urosepsis. The Food and Drug Administration (FDA) issued a label change to include this warning in December 2015 due to a small number of cases (n = 19) reported to the FDA Adverse Event Reporting System. Details of these cases are limited and none involved empagliflozin. To date, there has been no published literature comprehensively describing serious UTIs attributed to empagliflozin. We describe a case of septic shock due to Serratia marcescens pyelonephritis and bacteremia that required intensive care unit admission in a well-controlled, type 2 diabetic patient who had begun taking empagliflozin 2 months prior. The patient was treated successfully with intravenous antibiotics followed by oral ciprofloxacin. After discontinuation of empagliflozin and completion of antibiotic therapy, no subsequent UTIs were documented in the following 4 months.

Risk Factors in Diabetes and Pregnant Women with Urinary Tract Infections Compared to Younger Aged Female.

2018 ◽  
Vol 1 (3) ◽  
pp. 26-38
Author(s):  
Abdulghani Mohamed Alsamarai ◽  
Shler Ali Khorshed
Keyword(s):  
Risk Factors ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Pregnant Women ◽  
Female Student ◽  
Mean Value ◽  
Infected Female ◽  
Significant Difference ◽  
Tract Infections

Background: Urinary tract infection is common with health impact in women and characterised by failure to treatment and recurrent episodes. Aim: This study was conducted to determine the risk factors for the development of urinary tract infection in diabetic and pregnant women in comparison to student female. Materials and methods: A prospective cross-sectional study conducted during the period from 1st of June 2015 to the end of January 2016. The population included in the study are 563 women, of them 425 were outpatients, and 138 were inpatients. Their age range between 18 and 80 years, with a mean age of 33.59±15.29 years. Urine samples collected and cultured on blood agar and MacConkey agar by spread plate technique. Bacterial colonies with different morphology were selected, purified and identified according to their biochemical characteristics using conventional standard methods. Results: In diabetic women, there were no significant difference in mean age and BMI values between culture positive and culture negative groups. However, pus cell mean scale was significantly higher [P=0.000] in women with urinary tract infection [1.76±1.25] than in those with negative culture [0.69±1.00]. In pregnant women, BMI mean value was significantly [P=0.013] lower in pregnant women with UTI [26.14] as compared to those without infection [26.99]. Pus cell scale mean value was significantly [P=0.000] higher in pregnant women with UTI [1.55] than women with negative UTI [0.85]. While there was no significant difference in mean age between UTI positive and negative pregnant women. In female student, there was a significant difference between UTI infected and non-infected in mean age [P=0.041] and pus cell scale [P=0.000]. However, BMI was not significantly different between infected and non-infected female student. Other risk factors association are variables in the 3 groups when analysed using X2, while AUC and OR show different trends of association between risk factors and UTI. Conclusion: BMI, pus cell scale, child number, delivery method, operation history and hospital setting were significantly associated with culture positivity in the 3 studied groups as determined by AUC. While OR confirmed association with pus sale scale in the 3 groups.

Detection of tox A gene in Pseudomonas aeruginosa that isolates from different clinical cases by using PCR.

2018 ◽  
pp. 26
Author(s):  
Rana M. Abdullah Al-Shwaikh ◽  
Abbas Falih Alornaaouti
Keyword(s):  
Molecular Weight ◽  
Pseudomonas Aeruginosa ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Otitis Media ◽  
Urinary Tract Infections ◽  
Gel Electrophoresis ◽  
Wound Infections ◽  
Tract Infections

       Current study obtained (75) isolate of Pseudomonas aeruginosa collected from different cases included : 28 isolates from otitis media, 23 isolates from burn infections, 10 isolates from wound infections, 8 isolates from urinary tract infections and 6 isolates from blood, during the period between 1/9/2014 to 1/11/2014        The result revealed that the tox A gene was present in 54 isolates (72%) of Pseudomonas aeruginosa. The gel electrophoresis showed that the molecular weight of tox A gene was 352 bp. The result shows 17 isolates (60.71%) from otitis media has tox A gene, 18 isolates (78.26%) from burn followed by 8 isolate (80%) from wound infection and 5 isolates (62.5%) from urinary tract infection , finally 6 isolates (100%) from blood have this gene.

URINARY INFECTION AT DEPARTMENT OF UROLOGY OF HUE UNIVERSITY OF MEDICINE AND PHARMACY HOSPITAL

2018 ◽  
pp. 100-108
Author(s):  
Dinh Khanh Le ◽  
Dinh Dam Le ◽  
Khoa Hung Nguyen ◽  
Xuan My Nguyen ◽  
Minh Nhat Vo ◽  
...  
Keyword(s):  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Urinary Tract Infections ◽  
Urine Culture ◽  
Clinical Manifestations ◽  
University Hospital ◽  
E Coli ◽  
Positive Urine ◽  
Tract Infections

Objectives: To investigate clinical characteristics, bacterial characteristics, drug resistance status in patients with urinary tract infections treated at Department of Urology, Hue University Hospital. Materials and Method: The study was conducted in 474 patients with urological disease treated at Department of Urology, Hue Universiry Hospital from July 2017 to April 2018. Urine culture was done in the patients with urine > 25 Leu/ul who have symptoms of urinary tract disease or infection symptoms. Patients with positive urine cultures were analyzed for clinical and bacterial characteristics. Results: 187/474 (39.5%) patients had symptoms associated with urinary tract infections. 85/474 (17.9%) patients were diagnosed with urinary tract infection. The positive urine culture rate was 45.5%. Symptoms of UTI were varied, and no prominent symptoms. E. coli accounts for the highest proportion (46.67%), followed by, Staphycoccus aureus (10.67%), Pseudomonas aeruginsa (8,0%), Streptococcus faecali and Proteus (2.67%). ESBL - producing E. coli was 69.23%, ESBL producing Enterobacter spp was 33.33%. Gram-negative bacteria are susceptible to meropenem, imipenem, amikacin while gram positive are vancomycin-sensitive. Conclusions: Clinical manifestations of urinary tract infections varied and its typical symptoms are unclear. E.coli is a common bacterium (46.67%). Isolated bacteria have a high rate of resistance to some common antibiotics especially the third generation cephalosporins and quinolones. Most bacteria are resistant to multiple antibiotics at the same time. Gram (+) bacteria are susceptible to vancomycin, and gram (-) bacteria are susceptible to cefoxitin, amikacin, and carbapenem. Key words: urinary tract infection

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