Hepatotoxicity Associated with the Use of Anti-TNF-α Agents
Abstract Medications to inhibit the actions of tumour necrosis factor alpha have revolutionized the treatment of several pro-inflammatory autoimmune conditions. Despite their many benefits, several serious side effects exist and adverse reactions do occur from these medications. While many of the medications’ potential adverse effects were anticipated and recognized in clinical trials prior to drug approval, several more rare adverse reactions were recorded in the literature as the popularity, availability and distribution of these medications grew. Of these potential adverse reactions, liver injury, althoug...
Source: Drug Safety - December 21, 2015 Category: Drugs & Pharmacology Source Type: research

Renal and Bone Adverse Effects of a Tenofovir-Based Regimen in the Treatment of HIV-Infected Children: A Systematic Review
Conclusion This systematic review summarises the reports of renal and bone adverse effects of a TDF-containing regimen in the treatment of HIV-infected children. Our findings suggest that the benefits of using TDF in children need to be balanced against the potential risk of toxicity. (Source: Drug Safety)
Source: Drug Safety - December 21, 2015 Category: Drugs & Pharmacology Source Type: research

Appropriate Polypharmacy and Medicine Safety: When Many is not Too Many
Abstract The use of multiple medicines (polypharmacy) is increasingly common in middle-aged and older populations. Ensuring the correct balance between the prescribing of ‘many’ drugs and ‘too many’ drugs is a significant challenge. Clinicians are tasked with ensuring that patients receive the most appropriate combinations of medications based on the best available evidence, and that medication use is optimised according to patients’ clinical needs (appropriate polypharmacy). Historically, polypharmacy has been viewed negatively because of the associated medication safety risks, such ...
Source: Drug Safety - December 21, 2015 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance is … Vigilance
Abstract The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and...
Source: Drug Safety - December 21, 2015 Category: Drugs & Pharmacology Source Type: research

Risk of Inflammatory Bowel Disease with Oral Contraceptives and Menopausal Hormone Therapy: Current Evidence and Future Directions
Abstract Crohn’s disease (CD) and ulcerative colitis (UC), collectively known as inflammatory bowel diseases, are archetypical inflammatory disorders of the gastrointestinal tract with rising incidence worldwide. Although the role of genetic factors in disease development has been highlighted by genome-wide association studies, environmental risk factors likely play a pivotal role in development of CD and UC. Prior observational studies have suggested a link between exogenous hormone use and risk of CD and UC. Specifically, studies have shown an association between oral contraceptive use and risk of CD and m...
Source: Drug Safety - December 12, 2015 Category: Drugs & Pharmacology Source Type: research

Risk of Seizures Associated with Antidepressant Use in Patients with Depressive Disorder: Follow-up Study with a Nested Case–Control Analysis Using the Clinical Practice Research Datalink
Conclusion Current use of SSRIs or SNRIs was associated with a twofold increased risk of first-time seizures compared with non-use, while current use of TCAs (mostly low dose) was not associated with seizures. Treatment initiation in SSRI and SNRI users was associated with a higher risk of seizures than longer-term treatment. (Source: Drug Safety)
Source: Drug Safety - December 9, 2015 Category: Drugs & Pharmacology Source Type: research

Tools for Assessing Potential Significance of Pharmacist Interventions: A Systematic Review
Conclusions The majority of tools focused primarily on assessing clinical aspects and failed to detect comprehensive impacts. The heterogeneity of tools and assessment processes hindered our ability to synthesize the results of evaluations. Limited results for their validity and reliability cast doubt on the credibility of this methodology for justification of the value of PIs. Recommendations for development of tools with optimal theoretical, pragmatic, and psychometric properties are proposed. (Source: Drug Safety)
Source: Drug Safety - December 9, 2015 Category: Drugs & Pharmacology Source Type: research

Advances in the Pharmacogenomics of Adverse Drug Reactions
Abstract Rapid developments in pharmacogenomics have been noticeable in recent years, and much of this knowledge has improved understanding of adverse drug reactions. This improved knowledge has largely been the result of improved sequencing technologies and falling costs in this area, as well as improved statistical techniques to analyse the data derived from studies. While the genetic reasons behind adverse drug reactions are becoming better understood, translation of this knowledge, particularly in terms of biomarkers that might be clinically applicable at the bedside, has been more difficult. Understanding of ...
Source: Drug Safety - December 9, 2015 Category: Drugs & Pharmacology Source Type: research

Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase ®
Abstract Introduction In 2008, the US FDA issued an alert about an increased risk of psychiatric events associated with montelukast. Recent national pharmacovigilance analyses in Sweden, France and Spain detected a potential increase in reporting risk of the association. Aim Our objective was to analyse spontaneous reports of psychiatric events in children and adolescents worldwide treated with montelukast. Methods We conducted a retrospective analysis of Individual Case Safety Reports (ICSRs) recorded up to 1 Janu...
Source: Drug Safety - November 30, 2015 Category: Drugs & Pharmacology Source Type: research

What Is the Plural of a ‘Yellow’ Anecdote?
(Source: Drug Safety)
Source: Drug Safety - November 23, 2015 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - November 19, 2015 Category: Drugs & Pharmacology Source Type: research

Mortality Risk of Hypnotics: Strengths and Limits of Evidence
Abstract Sleeping pills, more formally defined as hypnotics, are sedatives used to induce and maintain sleep. In a review of publications for the past 30 years, descriptive epidemiologic studies were identified that examined the mortality risk of hypnotics and related sedative–anxiolytics. Of the 34 studies estimating risk ratios, odds ratios, or hazard ratios, excess mortality associated with hypnotics was significant (p 
Source: Drug Safety - November 13, 2015 Category: Drugs & Pharmacology Source Type: research

The Association Between Potentially Inappropriate Prescribing and Medication-Related Hospital Admissions in Older Patients: A Nested Case Control Study
Conclusion Our study shows that patients with potentially inappropriate prescribing detected with the STOPP & START 2008 criteria are at risk of preventable medication-related hospital admissions. The STOPP & START 2008 criteria can be used to identify older people at risk of medication-related problems. (Source: Drug Safety)
Source: Drug Safety - November 9, 2015 Category: Drugs & Pharmacology Source Type: research

Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial
We examined how making certain modifications to the way drug risk information is communicated has an impact on comprehension and behavioral intentions, including the user’s likelihood of discontinuing the drug. We also studied how comprehension varied by respondent characteristics, health literacy skills, risk perceptions, and trust in the message. Results Based on a five-item comprehension index, the revised version of the message was associated with significantly greater comprehension of the information relative to the standard version (63 vs 52 % correct, p 
Source: Drug Safety - November 7, 2015 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reactions Reported to a National HIV & Tuberculosis Health Care Worker Hotline in South Africa: Description and Prospective Follow-Up of Reports
Conclusion Queries about rashes, DILIs and kidney injuries were common. Detection and management of these ADRs should be included in HCW training. In cases with follow-up, concordance with advice was high, and HCWs reported improvement in the majority. (Source: Drug Safety)
Source: Drug Safety - November 7, 2015 Category: Drugs & Pharmacology Source Type: research

Reversal Strategies for NOACs: State of Development, Possible Clinical Applications and Future Perspectives
Abstract The non-vitamin K antagonist oral anticoagulants (NOACs) are used for thromboembolic prophylaxis of patients with atrial fibrillation and in the treatment as well as secondary prophylaxis of patients with venous thromboembolism. Even though NOACs have a better safety profile than vitamin K antagonists (VKAs), there will still be bleeding complications on NOAC treatment. In some cases, stopping the NOAC and non-drug-related management such as manual compression and interventional endoscopy will be sufficient to stop the bleeding. In more serious bleeding events and before acute surgery, coagulation factor ...
Source: Drug Safety - October 30, 2015 Category: Drugs & Pharmacology Source Type: research

An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies
Abstract Introduction Although it seems reasonable to suppose that a drug that increases the risk of an adverse event might tend to show increased disproportionality statistics in spontaneous reporting databases, that relationship is not clear. Therefore, an empirical approach was taken to investigate the relationship between proportional reporting ratios (PRRs) and relative risk (RR) estimates from formal studies in a set of known adverse drug reactions (ADRs). Methods Drug-event pairs that were the subject of pharmacovigilance-driven European regulator...
Source: Drug Safety - October 27, 2015 Category: Drugs & Pharmacology Source Type: research

Authors’ Reply to Sibel Yöntem and Colleagues’ Comment on “Indigenous Medicine Use for Sex Selection During Pregnancy and Risk of Congenital Malformations: A Population-Based Case-Control Study in Haryana, India”
(Source: Drug Safety)
Source: Drug Safety - October 27, 2015 Category: Drugs & Pharmacology Source Type: research

Comment on: “Indigenous Medicine Use for Sex Selection During Pregnancy and Risk of Congenital Malformations: A Population-Based Case–Control Study in Haryana, India”
(Source: Drug Safety)
Source: Drug Safety - October 27, 2015 Category: Drugs & Pharmacology Source Type: research

Testosterone Replacement Therapy and Mortality in Older Men
Abstract While US testosterone prescriptions have tripled in the last decade with lower trends in Europe, debate continues over the risks, benefits and appropriate use of testosterone replacement therapy (TRT). Several authors blame advertising and the availability of more convenient formulations, whilst others have pointed out that the routine testing of men with erectile dysfunction (ED) (a significant marker of cardiovascular risk) and those with diabetes would inevitably increase the diagnosis of hypogonadism and lead to an increase in totally appropriate prescribing. They commented that this was merely an app...
Source: Drug Safety - October 19, 2015 Category: Drugs & Pharmacology Source Type: research

Quantitative Risk–Benefit Analysis of Probiotic Use for Irritable Bowel Syndrome and Inflammatory Bowel Disease
Abstract Probiotics have seen widespread use for a variety of gastrointestinal problems, especially in two common disorders: irritable bowel syndrome and inflammatory bowel disease. Since a wide variety of probiotic preparations has been used, and despite a large number of studies performed, a great deal of heterogeneity exists among them. Straightforward evidence-based recommendations for the use of probiotics in irritable bowel syndrome and inflammatory bowel disease have thus been difficult to formulate. In an effort to improve understanding of the risk–benefit balance of probiotics in these condition...
Source: Drug Safety - October 14, 2015 Category: Drugs & Pharmacology Source Type: research

The Contribution of National Spontaneous Reporting Systems to Detect Signals of Torsadogenicity: Issues Emerging from the ARITMO Project
Conclusions We found differences across and within national SRSs in the reporting of drug-induced TdP, which finally resulted in five potential new signals of torsadogenicity. These findings warrant targeted pharmacovigilance studies to formally assess the existence of actual drug–event associations. (Source: Drug Safety)
Source: Drug Safety - October 8, 2015 Category: Drugs & Pharmacology Source Type: research

Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs
Abstract Use of highly pure antigens to improve vaccine safety has led to reduced vaccine immunogenicity and efficacy. This has led to the need to use adjuvants to improve vaccine immunogenicity. The ideal adjuvant should maximize vaccine immunogenicity without compromising tolerability or safety. Unfortunately, adjuvant research has lagged behind other vaccine areas such as antigen discovery, with the consequence that only a very limited number of adjuvants based on aluminium salts, monophosphoryl lipid A and oil emulsions are currently approved for human use. Recent strategic initiatives to support adjuvant...
Source: Drug Safety - October 8, 2015 Category: Drugs & Pharmacology Source Type: research

Feasibility of Prioritizing Drug–Drug-Event Associations Found in Electronic Health Records
Abstract Background and Objective Several studies have demonstrated the ability to detect adverse events potentially related to multiple drug exposure via data mining. However, the number of putative associations produced by such computational approaches is typically large, making experimental validation difficult. We theorized that those potential associations for which there is evidence from multiple complementary sources are more likely to be true, and explored this idea using a published database of drug–drug-adverse event associations derived from electronic health records (EHRs). ...
Source: Drug Safety - October 8, 2015 Category: Drugs & Pharmacology Source Type: research

Statistical Signal Detection as a Routine Pharmacovigilance Practice: Effects of Periodicity and Resignalling Criteria on Quality and Workload
Conclusions In real-life PV practice, signal detection and validation are recurrent periodic activities. Some true signals are only discovered upon resignalling. Our results demonstrate resignalling criteria with high signal detection quality and high efficiency. We found potential earlier detection of true signals using monthly SSD. Additional studies about resignalling should be performed to complement our findings. (Source: Drug Safety)
Source: Drug Safety - September 21, 2015 Category: Drugs & Pharmacology Source Type: research

Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis
Conclusion Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising. (Source: Drug Safety)
Source: Drug Safety - September 18, 2015 Category: Drugs & Pharmacology Source Type: research

Impact on Drug Safety of Variation in Adherence: The Need for Routinely Reporting Measures of Dose Intensity in Medication Safety Studies Using Electronic Health Data
Abstract Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses used when undertaking meta-analyses. Non-adherence with therapy is common in the practice setting and varies across countries and settings. Inter-country differences in the registration of medicines may also result in different product strengths being available in different countries. These ...
Source: Drug Safety - September 18, 2015 Category: Drugs & Pharmacology Source Type: research

15th ISoP Annual Meeting “Cubism in Pharmacovigilance” Prague, Czech Republic 27-30 October, 2015
(Source: Drug Safety)
Source: Drug Safety - September 15, 2015 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Hyperglycaemia and Diabetes
Abstract Drug-induced hyperglycaemia and diabetes is a global issue. It may be a serious problem, as it increases the risk of microvascular and macrovascular complications, infections, metabolic coma and even death. Drugs may induce hyperglycaemia through a variety of mechanisms, including alterations in insulin secretion and sensitivity, direct cytotoxic effects on pancreatic cells and increases in glucose production. Antihypertensive drugs are not equally implicated in increasing serum glucose levels. Glycaemic adverse events occur more frequently with thiazide diuretics and with certain beta-blocking agents tha...
Source: Drug Safety - September 14, 2015 Category: Drugs & Pharmacology Source Type: research

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection
Conclusion An EHR-based system may have additional value for signal detection, alongside already established systems, especially in the presence of adverse events with a high background incidence. While the SRS appeared to be more cost effective overall, for some events the costs associated with signal detection in the EHR might be justifiable. (Source: Drug Safety)
Source: Drug Safety - September 14, 2015 Category: Drugs & Pharmacology Source Type: research

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A National Analysis of Data from 10-Year Post-marketing Surveillance
Conclusion Thanks to the largest national DRESS case series ever reported, we were able to hypothesize, for the first time, that there is an association between use of drugs containing an aromatic ring in their chemical structure and DRESS. This might aid understanding of the aetiology of DRESS and facilitate diagnosis. (Source: Drug Safety)
Source: Drug Safety - September 14, 2015 Category: Drugs & Pharmacology Source Type: research

A Note on the Validity and Reliability of Multi-Criteria Decision Analysis for the Benefit–Risk Assessment of Medicines
Abstract The comparative evaluation of benefits and risks is one of the most important tasks during the development, market authorization and post-approval pharmacovigilance of medicinal products. Multi-criteria decision analysis (MCDA) has been recommended to support decision making in the benefit–risk assessment (BRA) of medicines. This paper identifies challenges associated with bias or variability that practitioners may encounter in this field and presents solutions to overcome them. The inclusion of overlapping or preference-complementary criteria, which are frequent violations to the assumptions of thi...
Source: Drug Safety - September 9, 2015 Category: Drugs & Pharmacology Source Type: research

Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Proton Pump Inhibitors, or Metoclopramide: A Population-Based Nested Case-Control Study
Conclusions Compared with non-use of any study drug, current domperidone use was associated with sudden cardiac death in nested case-control and case-crossover analyses, with a suggestion of higher risk in older persons and users of higher daily doses. (Source: Drug Safety)
Source: Drug Safety - September 8, 2015 Category: Drugs & Pharmacology Source Type: research

Signal for Thrombosis with Eltrombopag and Romiplostim: A Disproportionality Analysis of Spontaneous Reports Within VigiBase ®
Conclusion This study suggests the presence of a signal for an increased risk of thrombosis with eltrombopag compared with romiplostim. These results must be confirmed and quantified by large aetiological pharmacoepidemiological studies. (Source: Drug Safety)
Source: Drug Safety - September 4, 2015 Category: Drugs & Pharmacology Source Type: research

Future Proofing Adverse Event Monitoring
(Source: Drug Safety)
Source: Drug Safety - September 1, 2015 Category: Drugs & Pharmacology Source Type: research

Safety Profile of Certolizumab Pegol in Patients with Immune-Mediated Inflammatory Diseases: A Systematic Review and Meta-Analysis
Conclusion Safety data on CZP suggest an overall favorable tolerability profile, with infections being the most common AE. However, CZP-treated patients had a twofold higher risk of infectious SAEs than control patients. Large observational studies and data from national registries are needed to detect rare AEs, which might occur after long-term exposures to CZP. (Source: Drug Safety)
Source: Drug Safety - August 28, 2015 Category: Drugs & Pharmacology Source Type: research

Experiences and Lessons From Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
Conclusions The reported experiences of four NCs that have undertaken CEM studies on ACTs indicate that CEM has helped to build pharmacovigilance capacity within NCs and monitoring sites and that HCPs are willing to participate in CEM programmes; however, the method was found to be labour intensive and data management was identified as a challenge. Reducing the workload associated with CEM, particularly in relation to data management, and integrating the method into the routine work of HCPs and NCs should be considered for future implementation. (Source: Drug Safety)
Source: Drug Safety - August 13, 2015 Category: Drugs & Pharmacology Source Type: research

Modelling Hospitalisation Ratios for Febrile Convulsions and Severe Varicella Under Combined Measles, Mumps, Rubella, and Varicella (MMRV—Priorix-Tetra™) Compared to Separate MMR + V Vaccination
Conclusions MMRV use instead of MMR + V can substantially reduce the number of hospitalisation days, despite increased FC risk when MMRV is used as a first dose of measles-containing vaccine. (Source: Drug Safety)
Source: Drug Safety - August 7, 2015 Category: Drugs & Pharmacology Source Type: research

Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database
The objective of this study was to supplement existing knowledge of the reported safety of perflutren using statistical analysis of spontaneous reports. Methods We analyzed information from the US Food and Drug Administration Adverse Event Reporting System using a disproportionality analysis. Analysis of overall reporting for perflutren was supplemented by subset (age, indication) analysis. A signal of disproportionate reporting (SDR) was defined as EB05>2. Results Overall, 18/380 Preferred Terms and 1/83 Standardized Medical Queries had SDR...
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies
Conclusions Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise the usefulness of social media for safety surveillance. (Source: Drug Safety)
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Authors’ Reply to Cotton and Nicol’s Comment on “Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study from Ethiopia”
(Source: Drug Safety)
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Comment on: “Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study from Ethiopia”
(Source: Drug Safety)
Source: Drug Safety - August 5, 2015 Category: Drugs & Pharmacology Source Type: research

Vaccine–Drug Interactions: Cytokines, Cytochromes, and Molecular Mechanisms
Abstract Vaccinations are recommended throughout life to reduce the risk of vaccine-preventable diseases and their sequelae. Vaccines are often administered in patients with chronic diseases who are likely to be treated with several drugs. A growing number of clinical observations have indicated the possibility of interactions between vaccines and drugs, leading to changes in drug metabolism after vaccination. These interactions represent a significant concern because of the increasing use of vaccines in older patients who are likely to be treated with several drugs. Because of the possible implications of adverse...
Source: Drug Safety - August 4, 2015 Category: Drugs & Pharmacology Source Type: research

Variation in Association Between Thiazolidinediones and Heart Failure Across Ethnic Groups: Retrospective analysis of Large Healthcare Claims Databases in Six Countries
Conclusion The risk of both oedema and heart failure with thiazolidinediones was higher in predominantly Caucasian countries than in the Asian countries assessed. Assessment of adverse events by ethnicity may support safer medicine use. (Source: Drug Safety)
Source: Drug Safety - July 28, 2015 Category: Drugs & Pharmacology Source Type: research

Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications
(Source: Drug Safety)
Source: Drug Safety - July 23, 2015 Category: Drugs & Pharmacology Source Type: research

Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database
Conclusions Although hepatocellular injury following long-term tolvaptan treatment in ADPKD subjects was infrequent and reversible, the potential for serious irreversible injury exists. Regular monitoring of transaminase levels is warranted in this patient population. (Source: Drug Safety)
Source: Drug Safety - July 19, 2015 Category: Drugs & Pharmacology Source Type: research

Selective Serotonin Reuptake Inhibitor Use and Perioperative Bleeding and Mortality in Patients Undergoing Coronary Artery Bypass Grafting: A Cohort Study
Conclusion In this large cohort study, neither SSRIs nor other antidepressants were associated with elevated rates of major bleed, or in-hospital mortality. (Source: Drug Safety)
Source: Drug Safety - July 19, 2015 Category: Drugs & Pharmacology Source Type: research

Photosensitivity with Angiotensin II Receptor Blockers: A Retrospective Study Using Data from VigiBase ®
Conclusions Photosensitivity reactions have been reported with almost all ARBs in VigiBase® with a positive disproportionality for irbesartan and losartan. Considering that ARBs share the same chemical structure, which may have the same response to sunlight, it is plausible to consider photosensitivity as a possible class effect. Physicians and patients should be aware of potentially serious photosensitivity reactions related to treatment with ARBs. (Source: Drug Safety)
Source: Drug Safety - July 18, 2015 Category: Drugs & Pharmacology Source Type: research

Walking the Fine Line between Science and Culture
(Source: Drug Safety)
Source: Drug Safety - July 15, 2015 Category: Drugs & Pharmacology Source Type: research

Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14
Abstract Exposure-response (ER) analysis has evolved as an important tool to evaluate the effect of a drug on cardiac repolarization, as reflected in the QTc interval. It has been suggested that careful electrocardiogram (ECG) evaluation in ‘first-in-human’ studies using ER analysis could replace or serve as an alternative to the E14 ‘thorough QT’ study. This commentary shares and discusses the results of a recently conducted study with the objective to evaluate this approach. Six drugs with a well-characterized QT effect, five of which are known QT prolongers, were evaluated in a study des...
Source: Drug Safety - July 11, 2015 Category: Drugs & Pharmacology Source Type: research