Adverse Drug Reports Research Articles

Incidence of cutaneous T-cell lymphoma (CTCL) after chronic exposure to thiazides: pharmacovigilance analysis from the RADAR (Research on Adverse Drug events And Reports) Program

Incidence of cutaneous T-cell lymphoma (CTCL) after chronic exposure to thiazides: pharmacovigilance analysis from the RADAR (Research on Adverse Drug events And Reports) Program

Bullous skin disorders associated with PD-1 and PDL-1 inhibitors: Pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) from the Research on Adverse Drug events And Reports (RADAR) Program

Bullous skin disorders associated with PD-1 and PDL-1 inhibitors: Pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) from the Research on Adverse Drug events And Reports (RADAR) Program

Incidence of cutaneous adverse events after exposure to tenofovir-emtricitabine in HIV-uninfected vs HIV-infected patients: Pharmacovigilance analysis of a large Midwestern US patient population from the RADAR (Research on Adverse Drug events And Reports)

Incidence of cutaneous adverse events after exposure to tenofovir-emtricitabine in HIV-uninfected vs HIV-infected patients: Pharmacovigilance analysis of a large Midwestern US patient population from the RADAR (Research on Adverse Drug events And Reports)

Adverse events following the use of immune checkpoint inhibitors: An analysis of the WHO VigiAccess database.

e13118 Background: Immune checkpoint inhibitors (ICIs), especially ipilimumab (ipi) and nivolumab (nivo), have received approvals from the U.S. Food and Drug Administration for the treatment of multiple tumor types. These medications have shown great promise in the treatment of several malignancies but are associated with immune-related adverse events. This study was undertaken to better understand the patterns of adverse events following different ICIs. Methods: We used the World Health Organization (WHO) Vigiaccess Database, the largest adverse events reporting database, to identify, summarize, and report adverse drug events (AE) attributed to ipi and nivo. The database contains reports for ipi beginning in 2008 and for nivo beginning in 2012. We manually extracted the data from the database and conducted Chi-square tests to examine the difference in occurrence of AEs in various organ systems between patients receiving ipi and nivo. The five most common organ systems affected by AE associated with ipi and nivo were identified. Results: AEs were reported in 15,504 ipi users and 21,306 nivo users. Ipi users reported significantly higher AEs in gastrointestinal system compared to nivo users (p < 0.0001). Conversely, nivo users reported significantly higher AEs in respiratory disorders (p < 0.0001), skin and subcutaneous tissue organ systems (p = 0.0001), and neoplasms benign, malignant and unspecified (p < 0.0001) compared to ipi users. Conclusions: To our knowledge this is the largest study on reported AEs following ipi and nivo. The patterns of treatment-related AEs differed significantly for these two immune checkpoint inhibitor therapies. Further studies are required to guide treatment selection.[Table: see text]

Hyperkalemia in women with acne exposed to oral spironolactone: A retrospective study from the RADAR (Research on Adverse Drug Events and Reports) program.

PurposeThe necessity of serum potassium monitoring for healthy women who are prescribed spironolactone for acne has been debated. The aim of this study was to compare the incidence of hyperkalemia in women 18 to 45 years of age to that in women 46 to 65 years of age, when treated with oral spironolactone for acne.Methods and materialsData for all women 18 to 65 years of age who were prescribed oral spironolactone by a dermatologist for acne between January 2006 and October 2016 were extracted for analysis. Retrospective data were included for women who exhibited baseline serum potassium within the normal limits and who had repeat serum potassium monitoring within 12 months after initiation of spironolactone. The rate of incident hyperkalemia was determined.ResultsOf 618 women who received spironolactone for acne, 133 had serum potassium monitoring both before and after spironolactone initiation. Nine were excluded due to confounding comorbidities. Of the remaining 124 women, the mean age at initiation of spironolactone was 32 years (range, 18-57 years); 112 women were in the 18 to 45 years age group, and 12 were in the 46 to 65 years age group. All women had serum potassium within normal limits at baseline. Women in the 46 to 65 years age group had a significantly higher rate of incident hyperkalemia after spironolactone initiation compared with women 18 to 45 years of age (2 of 12 women [16.7%] vs. 1 of 112 women [< 1%]; p = .0245).ConclusionsAlthough controversy surrounds the clinical utility of serum potassium monitoring in healthy women exposed to spironolactone for acne, based on the findings from this large patient population, monitoring of serum potassium is warranted for women over 45 years of age given an age-related greater risk of hyperkalemia.

718 Hydroxychloroquine and cardiovascular events in patients with morphea: A report from the RADAR (Research on Adverse Drug events And Reports) program

718 Hydroxychloroquine and cardiovascular events in patients with morphea: A report from the RADAR (Research on Adverse Drug events And Reports) program

674 Hair loss and psychoactive medications: Stimulants and antidepressants: A retrospective analysis from the RADAR (Research on Adverse Drug events And Reports) Program

674 Hair loss and psychoactive medications: Stimulants and antidepressants: A retrospective analysis from the RADAR (Research on Adverse Drug events And Reports) Program

Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial

SummaryBackgroundDirectly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT.MethodsWe did a multicentre, analyst-blinded, randomised controlled superiority trial in 22 clinics in England (UK). Eligible participants were patients aged at least 16 years with active pulmonary or non-pulmonary tuberculosis who were eligible for DOT according to local guidance. Exclusion criteria included patients who did not have access to charging a smartphone. We randomly assigned participants to either VOT (daily remote observation using a smartphone app) or DOT (observations done three to five times per week in the home, community, or clinic settings). Randomisation was done by the SealedEnvelope service using minimisation. DOT involved treatment observation by a health-care or lay worker, with any remaining daily doses self-administered. VOT was provided by a centralised service in London. Patients were trained to record and send videos of every dose ingested 7 days per week using a smartphone app. Trained treatment observers viewed these videos through a password-protected website. Patients were also encouraged to report adverse drug events on the videos. Smartphones and data plans were provided free of charge by study investigators. DOT or VOT observation records were completed by observers until treatment or study end. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrolment. Intention-to-treat (ITT) and restricted (including only patients completing at least 1 week of observation on allocated arm) analyses were done. Superiority was determined by a 15% difference in the proportion of patients with the primary outcome (60% vs 75%). This trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN26184967.FindingsBetween Sept 1, 2014, and Oct 1, 2016, we randomly assigned 226 patients; 112 to VOT and 114 to DOT. Overall, 131 (58%) patients had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. In the ITT analysis, 78 (70%) of 112 patients on VOT achieved ≥80% scheduled observations successfully completed during the first 2 months compared with 35 (31%) of 114 on DOT (adjusted odds ratio [OR] 5·48, 95% CI 3·10–9·68; p<0·0001). In the restricted analysis, 78 (77%) of 101 patients on VOT achieved the primary outcome compared with 35 (63%) of 56 on DOT (adjusted OR 2·52; 95% CI 1·17–5·54; p=0·017). Stomach pain, nausea, and vomiting were the most common adverse events reported (in 16 [14%] of 112 on VOT and nine [8%] of 114 on DOT).InterpretationVOT was a more effective approach to observation of tuberculosis treatment than DOT. VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective, and cheaper option for supervision of daily and multiple daily doses than DOT.FundingNational Institute for Health Research.

"ADR PvPI" Android mobile app: Report adverse drug reaction at any time anywhere in India.

BACKGROUND:To improve the public health and promote instant adverse drug reaction (ADR) reporting, a need to develop an ADR Pharmacovigilance Programme of India (PvPI) mobile app was identified by the National Coordination CentrePvPI (NCCPvPI) to serve the Pan India ADR reporting. The objective of this study was to develop an indigenous Googlebased Android mobile application known as “ADR PvPI” and to analyze the ADRrelated data reported through this mobile application on pilot basis.MATERIALS AND METHODS:The ADR PvPI mobile application was indigenously developed by NCCPvPI officials within 6 months. The study of spontaneous ADR reporting was carried out between September 2017 and September 2018. This article provides an overview of the salient features of ADR PvPI mobile application, guides on how to fillin ADRs, reporting trends of ADR, types of ADR as per System Organ Class and pharmacological classes of drugs.RESULTS:Till date, >5500 users have downloaded the app with an average rating of 4.26. In that tenure, 262 reports have been received through ADR PvPI mobile app. During the year 2017, 3.55% of reports were received through ADR PvPI mobile app and the percentage of reports received by 2018 was 96.45%.CONCLUSION:The frequency of ADR reporting has significantly increased over the past 1 year and should be promoted further through awareness and training programs.

Melanoma subsequent to natalizumab exposure: A report from the RADAR (Research on Adverse Drug events And Reports) program

Melanoma subsequent to natalizumab exposure: A report from the RADAR (Research on Adverse Drug events And Reports) program

LB1516 Hyperkalemia in women with acne exposed to spironolactone in a large, urban, Midwestern U.S. population: A report from the Research on Adverse Drug Events and Reports Program (RADAR)

LB1516 Hyperkalemia in women with acne exposed to spironolactone in a large, urban, Midwestern U.S. population: A report from the Research on Adverse Drug Events and Reports Program (RADAR)

LB1501 Chronic exposure to statin drugs and association with melanoma: A report from the RADAR (Research on Adverse Drug Events and Reports) project

LB1501 Chronic exposure to statin drugs and association with melanoma: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Inflammatory bowel disease events after exposure to the interleukin-17 inhibitors ixekizumab and secukinumab: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Inflammatory bowel disease events after exposure to the interleukin-17 inhibitors ixekizumab and secukinumab: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Chronic daily dosing of PDE5 inhibitors (sildenafil or tadalafil) for pulmonary hypertension and risk of subsequent melanoma: A report from the Research on Adverse Drug Events and Reports (RADAR) project

Chronic daily dosing of PDE5 inhibitors (sildenafil or tadalafil) for pulmonary hypertension and risk of subsequent melanoma: A report from the Research on Adverse Drug Events and Reports (RADAR) project

Pyoderma gangrenosum subsequent to tumor necrosis factor α inhibitor exposure: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Pyoderma gangrenosum subsequent to tumor necrosis factor α inhibitor exposure: A report from the RADAR (Research on Adverse Drug Events and Reports) project

Inflammatory bowel disease events after exposure to interleukin 17 inhibitors secukinumab and ixekizumab: Postmarketing analysis from the RADAR (“Research on Adverse Drug events And Reports”) program

Inflammatory bowel disease events after exposure to interleukin 17 inhibitors secukinumab and ixekizumab: Postmarketing analysis from the RADAR (“Research on Adverse Drug events And Reports”) program

Crystallization of R-(+)-atenolol hydrochloride from racemic ionic liquid - A selective double decomposition green reaction

Atenolol is a cardioselective antihypertensive drug. It is classified under arylethanolamine β adrenergic receptor antagonists. Hypotensive action for this racemic drug was found to be selective for the S-(−)- β receptor blocking stereoisomer as this enantiomer was found to have 20 fold greater affinity for β1 adrenoreceptors when compared to β2 adrenoreceptors of human heart muscle. Albeit the action of the drug was mentioned as stereoselective, atenolol is always administered as racemic mixture only. Recently several adverse drug reports were published on atenolol treatment and the study suggested for intensive research on structure activity relationship of R-(+)-stereoisomer. In this study, we report the solid state structure of R-(+)-atenolol for the first time as hydrochloride salt. We also report a unique resolution process based on ionic liquid formation for obtaining this stereoisomer. The process is first of its kind for a pharmaceutical ionic liquid material. We believe that the atomic structure of R-(+)-stereoisomer will significantly contribute for understanding its biological activity when compared to its counter enantiomer.

242 Risk of nonmelanoma skin cancer after exposure to statin drugs: A report from the RADAR (Research on Adverse Drug events and Reports) project

Statin exposure and nonmelanoma skin cancer (NMSC) association is unclear. The aim of this study is to determine if there is an association between statin exposure and NMSC [basal cell cancer (BCC) and squamous cell cancer (SCC)], in a large patient population. The Northwestern Medicine Enterprise Data Warehouse medical record data repository (> 5 million patients) was searched for patients aged 18-89 years with at least 5 years of in-clinic follow-up. The statin-exposed population consisted of all patients taking a chronic statin medication (atorvastatin, cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin) for at least 12 months, while the control population consisted of non-statin-exposed patients. Data on age, gender, race, and NMSC diagnosis were collected. Adjusted odds ratios (aORs) were determined by multivariate logistic regression. Of 440,289 patients meeting inclusion criteria, 56,117 had statin exposure, of whom 3,590 (6.4%) were diagnosed with NMSC, yielding a significant association between NMSC and statin exposure (aOR: 2.39; 95%CI 2.30-2.49; p < 0.0001). Data for the 40 to 75-year-old group chosen to follow recent statin recommendations from US Preventative Services Task Force also showed a significant association between statin exposure and subsequent NMSC diagnosis (aOR: 1.63; 95%CI 1.56-1.70; p < 0.0001). In addition, statin exposure and subsequent diagnoses of BCC or SCC were examined in separate populations. This yielded further significant associations between statin exposure and subsequent BCC diagnosis (aOR: 1.46; 95%CI 1.38-1.53; p < 0.0001), as well as subsequent SCC diagnosis (aOR: 2.12; 95%CI 1.97-2.29; p < 0.0001). These findings highlight an association between chronic statin exposure and subsequent incident NMSC in the study population.

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

BackgroundAdverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported.ObjectiveOur objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting.MethodsThis qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice.ResultsWe completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation.ConclusionsExisting reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care.

LB953 Spironolactone and psoriasis outcome in young adult women: A report from the RADAR (Research on Adverse Drug events And Reports) project

LB953 Spironolactone and psoriasis outcome in young adult women: A report from the RADAR (Research on Adverse Drug events And Reports) project