A5051558732- Pharmacovigilance and Adverse Drug Reactions
- Pharmaceutical Practices and Patient Outcomes
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical studies and practices
- Prostate Cancer Treatment and Research
- Asthma and respiratory diseases
- Prostate Cancer Diagnosis and Treatment
- Blood Pressure and Hypertension Studies
- Pharmaceutical industry and healthcare
- Pharmaceutical Economics and Policy
- Advanced Radiotherapy Techniques
- Respiratory and Cough-Related Research
- Poisoning and overdose treatments
- Patient-Provider Communication in Healthcare
- Drug-Induced Hepatotoxicity and Protection
- Biomedical Ethics and Regulation
- Schizophrenia research and treatment
- Opioid Use Disorder Treatment
- Heart Failure Treatment and Management
- Atrial Fibrillation Management and Outcomes
- Hepatocellular Carcinoma Treatment and Prognosis
- Biosimilars and Bioanalytical Methods
- Optimism, Hope, and Well-being
- Statistical Methods and Bayesian Inference
- Grit, Self-Efficacy, and Motivation
Center for Drug Evaluation and Research
2013-2025
United States Food and Drug Administration
2013-2025
Case Western Reserve University
2007-2024
University School
2007-2024
University Hospitals of Cleveland
2024
University of Florida
2019
Columbus Oncology and Hematology Associates
2019
Software (Spain)
2019
Center for Surveillance, Epidemiology, and Laboratory Services
2013-2017
Food and Drug Administration
2012-2015
Importance Clozapine is an effective medication for treatment-resistant schizophrenia but can cause agranulocytosis. Since its approval, patients taking clozapine have been required to undergo regular blood testing screen neutropenia. In 2015, the risk management programs were merged into a single evaluation and mitigation strategy (REMS), which mandates that prescribers certification process in they attest understanding of agranulocytosis commit performing testing. It unknown how REMS...
ABSTRACT Purpose To estimate the number of acetaminophen overdose‐related emergency department (ED) visits and hospitalizations in United States, characterize these by intentionality, age, gender, compare strengths limitations utilized databases. Methods We used data from National Hospital Ambulatory Medical Care Survey (NHAMCS) Electronic Injury Surveillance System (NEISS) to relevant ED States between 2000 2007, Discharge (NHDS) 1991 2006. estimates their standard errors were calculated...
The goal of this study is to summarize trends in rates adverse events attributable acetaminophen use, including hepatotoxicity and mortality.A comprehensive analysis data from three national surveillance systems estimated acetaminophen-related identified different settings, calls poison centers (2008-2012), emergency department visits (2004-2012), inpatient hospitalizations (1998-2011). Rates were calculated per setting, census population, distributed drug units.Rates center with exposures...
Alzheimer disease is affecting a significant portion of the aging population worldwide. Despite extensive research over years, comprehensive understanding its underlying mechanisms and effective treatments remains elusive. Meanwhile, animal models, such as mouse, zebrafish, Drosophila, C. elegans, have proven invaluable in studying human diseases. In response, we developed DARG, Database disease-related genes model organisms, designed to bridge gap between geneticists investigating molecular...
Abstract Purpose To characterize the nature of a heparin contaminant's clinical effects in cases reported to Adverse Event Reporting System (AERS). The FDA received reports heparin‐associated adverse events (AEs) starting late 2007–early 2008 during national investigation allergic‐type events. identified Baxter Healthcare‐brand product due its strongest association with Later, oversulfated chondroitin sulfate (OSCS), heparin‐like contaminant, was discovered. Methods This study case series...
The tree-based scan statistic is a statistical data mining tool that has been used for signal detection with self-controlled design in vaccine safety studies. This disproportionality adjusts multiple testing evaluation of thousands potential adverse events. However, many drug questions are not well suited analysis. We propose method combines statistics propensity score–matched analysis new initiator cohorts, robust investigations safety. conducted plasmode simulations to evaluate...
ABSTRACT Purpose The major concern associated with isotretinoin treatment is its high teratogenic potential. Therefore, ensuring use of contraception while on therapy an important strategy for at‐risk patients and has been emphasized in all risk management programs. iPledge, the latest most rigorous program, requires, among other stipulations, monthly assessments contraceptive undergoing treatment. purpose this study to evaluate usage patterns assess concomitant contraceptives before after...
In a retrospective cohort study of patients enrolled in the UK Clinical Practice Research Datalink during 2000-2013, we evaluated long-term risks death, stroke, and acute myocardial infarction (AMI) adults prescribed clarithromycin. Patients were outpatients aged 40-85 years, who clarithromycin (n = 287,748), doxycycline 267,729), or erythromycin 442,999), Helicobacter pylori eradication therapy with proton pump inhibitor, amoxicillin, either 27,639) metronidazole 14,863). We analyzed time...
Importance Endothelin receptor antagonists are first-line therapy for pulmonary arterial hypertension (PAH). The first 2 agents approved in the class, bosentan and ambrisentan, initially carried boxed warnings hepatotoxicity required monthly liver function tests (LFTs) as part of a risk evaluation mitigation strategy (REMS); however, 2011, further safety data emerged on warning LFT requirements were removed. Objective To analyze changes use monitoring ambrisentan after to labeling REMS....
Products containing the sedative/hypnotic zolpidem were subject to Drug Safety Communications (DSCs) in January and May 2013 describing risk of next-morning impairment recommending lower starting doses particularly for women. This study aimed assess whether DSCs associated with prescribing-pattern changes between 2011 December 2013.We assessed overall dispensings zolpidem-containing products by conducting a time-series analysis. Analyses stratified gender because DSC contained...
Background: The Food and Drug Administration (FDA) issues drug safety communications (DSCs) to health care professionals, patients, the public when emerge related FDA-approved products. These messages are disseminated through social media ensure broad uptake. Objective: objective of this study was assess dissemination 2 DSCs released in 2013 for sleep aid zolpidem. Methods: We used MedWatcher Social program DataSift historic query tool aggregate Twitter Facebook posts from October 1, 2012...
Abstract Purpose Identifying hospitalizations for serious infections among patients dispensed biologic therapies within healthcare databases is important post‐marketing surveillance of these drugs. We determined the positive predictive value (PPV) an ICD‐10‐CM‐based diagnostic coding algorithm to identify hospitalization infection therapy FDA's Sentinel Distributed Database. Methods identified health plan members who met following criteria: (1) hospital ICD‐10‐CM discharge diagnosis between...
FDA issues Drug Safety Communications (DSCs) to alert health care professionals and the public about emerging safety information affecting prescription over-the-counter drugs. News media may amplify DSCs, but it is unclear how DSC messaging transmitted through media. We conducted a content analysis of lay coverage reaching broadest audience characterize amount two zolpidem DSCs from 2013. After first DSC, news stories increased 19 stories/week in preceding 3 months 153 following its release....
We evaluate the usefulness of pretreatment (111)Indium capromab pendetide (ProstaScint) planar imaging (immunoscintigraphy) plus single photon emission tomography co-registration with computerized scans to detect occult metastatic disease and predict for biochemical failure, in a cohort patients clinical diagnosis localized adenocarcinoma prostate referred primary radiotherapy.Patients were followed after radiotherapy evidence failure using 2 criteria specific antigen nadir +2 ng/ml American...
The Food and Drug Administration (FDA) issued a Public Health Advisory entitled "Suicidal Thinking in Children Adolescents Being Treated with Strattera (Atomoxetine)" on September 29, 2005. At FDA's request, the manufacturer subsequently added boxed warning to drug's labeling November 8, 2005.To evaluate whether for suicidal thinking atomoxetine's was associated change pattern of attention-deficit/hyperactivity disorder (ADHD) medication use.Patients who had an ADHD diagnosis were prescribed...
ABSTRACT Purpose Results of two randomized trials (ROADMAP and ORIENT) suggest that high‐dose (40 mg/day) olmesartan (Olm) is associated with increased cardiovascular mortality compared to placebo in diabetic patients. We evaluated the risks acute myocardial infarction (AMI) death patients initiating Olm an active comparator group, other angiotensin receptor blockers (ARBs), a focus on subgroups. Methods conducted cohort study who initiated or another ARB between 2003 2011, using UK Clinical...
In the randomized trial, Randomized Olmesartan and Diabetes Microalbuminuria Prevention, acute cardiovascular death was increased nearly fivefold in diabetic patients treated with high-dose olmesartan, an angiotensin receptor blocker (ARB), compared placebo.Medicare beneficiaries were entered into new-user cohorts of olmesartan or other ARBs followed on therapy for occurrence myocardial infarction, stroke, death. Analyses focused specific subgroups defined by diabetes status, ARB dose,...
Estimating hazard ratios (HR) presents challenges for propensity score (PS)-based analyses of cohorts with differential depletion susceptibles. When the treatment effect is not null, that were balanced at baseline tend to become unbalanced on characteristics over time as “susceptible” individuals drop out population risk differentially across groups due having outcome events. This imbalance in covariates causes marginal (population-averaged) HRs diverge from conditional (covariate-adjusted)...