Dopamine Agonists and Impulse Control Disorders: A Complex Association
AbstractImpulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The search terms were medical subject headings (MeSH) terms including “dopamine agonists” AND “disruptive disorders”, “impulse control disorders”, or “conduct disorders”. Articles had to fulfill the following criteria to be included: (i) the target problem wa...
Source: Drug Safety - August 31, 2017 Category: Drugs & Pharmacology Source Type: research

Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
(Source: Drug Safety)
Source: Drug Safety - August 30, 2017 Category: Drugs & Pharmacology Source Type: research

Drug-Induced QT Prolongation and Torsades de Pointes: An All-Exclusive Relationship or Time for an Amicable Separation?
AbstractQT prolongation was perceived as a major antiarrhythmic mechanism, but soon became a surrogate for torsades de pointes (TdP) instead. Drugs that prolong the QT interval range from having potent torsadogenic activity to no proarrhythmic action and even antiarrhythmic effects. Blockade of hERG channels is the  primary cause of TdP, but blockade/activation of other channels can also be torsadogenic. TdP is primarily caused by disturbances of TRIaD, but disturbance of wavelength can also contribute to TdP (where TRIaD is triangulation, reverse use dependence, instability and dispersion, and wavelength equ als cond...
Source: Drug Safety - August 29, 2017 Category: Drugs & Pharmacology Source Type: research

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer ’s Capture of Spontaneous Reports for Exposed Pregnancies
AbstractIntroductionPregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy.ObjectivesThe aim of this study was to evaluate postmarket capture of exposed pregnancies.MethodsPregnancy registries for drugs and biologics were identified in a systematic review. Through a standardized questionnaire, manufacturers provided information on (1) pregnancy registry enrollment and retention, and (2) worldwide receipt of spontaneous reports for exposed pregnancies. A validated algorithm for live-birth pregnancies allowed calculation of exposure rates per 100,000 live b...
Source: Drug Safety - August 24, 2017 Category: Drugs & Pharmacology Source Type: research

From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources
AbstractIn the last decade ‘big data’ has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily re fers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processe...
Source: Drug Safety - August 24, 2017 Category: Drugs & Pharmacology Source Type: research

A New Erice Report Considering the Safety of Medicines in the 21st Century
AbstractPharmacovogilance policy, methods and practice require transformation at all levels to create an integrated, comprehensive, continuously improving system, fulfilling the broader remit of overall healthcare vigilance. In pursuit of this vision, energetic measures, including active engagement with patients, are needed to reduce our ignorance about many aspects of patients ’ experience of medical therapies and their outcomes, including the benefits, but especially the extensive harm known to be caused by medical interventions. More information and communication in this domain will help set more accurate and real...
Source: Drug Safety - August 17, 2017 Category: Drugs & Pharmacology Source Type: research

Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China
ConclusionsThese EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China. (Source: Drug Safety)
Source: Drug Safety - August 16, 2017 Category: Drugs & Pharmacology Source Type: research

Deaths from Medicines: A Systematic Analysis of Coroners ’ Reports to Prevent Future Deaths
ConclusionCoroners ’ reports to prevent future deaths provide some information on medication errors and adverse reactions. They rarely identify new hazards. At present they are often addressed to local bodies, but this could mean that wider lessons are lost. (Source: Drug Safety)
Source: Drug Safety - August 14, 2017 Category: Drugs & Pharmacology Source Type: research

The 9th Biennial Conference on Signal Detection and Interpretation in Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - August 9, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance Using Textual Data: The Need to Go Deeper and Wider into the Con(text)
(Source: Drug Safety)
Source: Drug Safety - August 8, 2017 Category: Drugs & Pharmacology Source Type: research

Cardiac Harms of Sofosbuvir: Systematic Review and Meta-Analysis
ConclusionsThe pooled data from RCTs did not show an increased risk of cardiac outcomes, including arrhythmias (and bradycardia), among sofosbuvir-treated patients, although the overall quality of the evidence supporting this conclusion was very low.Registration: PROSPERO 2016:CRD42016033109 athttp://www.crd.york.ac.uk/PROSPERO/. (Source: Drug Safety)
Source: Drug Safety - August 7, 2017 Category: Drugs & Pharmacology Source Type: research

Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications
ConclusionsAlthough usingselected covariates for propensity score adjustment may not sufficiently reduce bias, large-scale propensity score matching offers a novel approach to consider to mitigate the effects of channeling bias. (Source: Drug Safety)
Source: Drug Safety - August 5, 2017 Category: Drugs & Pharmacology Source Type: research

Frequency and Nature of Medication Errors and Adverse Drug Events in Mental Health Hospitals: a Systematic Review
ConclusionMedication errors occur frequently in mental health hospitals and are associated with risk of patient harm. Effective interventions are needed to target these events and improve patient safety. (Source: Drug Safety)
Source: Drug Safety - August 3, 2017 Category: Drugs & Pharmacology Source Type: research

Antidepressant-Induced Acute Liver Injury: A Case –Control Study in an Italian Inpatient Population
ConclusionThe use of antidepressants is not as safe in terms of liver injury as expected; instead, the risk of antidepressant-induced liver injury is likely underestimated. The lack of significance does not reflect the absence of risk, but rather suggests the need to evaluate it in a wider setting of antidepressant users. (Source: Drug Safety)
Source: Drug Safety - August 2, 2017 Category: Drugs & Pharmacology Source Type: research

Treatment of Medication-Related Osteonecrosis of the Jaw and its Impact on a Patient ’s Quality of Life: A Single-Center, 10-Year Experience from Southern Italy
ConclusionsMR-ONJ-related QoL increased after pharmacological treatment and, more notably, after surgery, which may offer benefits to selected patients. QoL data may help clinicians in promoting tailored management of MR-ONJ. (Source: Drug Safety)
Source: Drug Safety - August 1, 2017 Category: Drugs & Pharmacology Source Type: research

A Pharmacoepidemiology Database System for Monitoring Risk Due to the Use of Medicines by New Zealand Primary Care Patients
AbstractIntroductionThe use of large record-linked healthcare databases for drug safety research and surveillance is now accepted practice. New Zealand ’s standardized national healthcare datasets provide the potential to automate the conduct of pharmacoepidemiological studies to provide rapid validation of medicine safety signals.ObjectivesOur objectives were to describe the methodology undertaken by a semi-automated computer system developed to rapidly assess risk due to drug exposure in New Zealand ’s population of primary care patients and to compare results from three studies with previously published find...
Source: Drug Safety - August 1, 2017 Category: Drugs & Pharmacology Source Type: research

Neurological Adverse Effects Attributable to β-Lactam Antibiotics: A Literature Review
Abstractβ-lactam antibiotics are commonly prescribed antibiotic drugs. To describe the clinical characteristics, risk markers and outcomes of β-lactam antibiotic-induced neurological adverse effects, we performed a general literature review to provide updated clinical data about the most used β-lactam an tibiotics. For selected drugs in each class available in France (ticarcillin, piperacillin, temocillin, ceftazidime, cefepime, cefpirome, ceftaroline, ceftobiprole, ceftolozane, ertapenem and aztreonam), a systematic literature review was performed up to April 2016 via an electronic search on PubMed . Articl...
Source: Drug Safety - July 28, 2017 Category: Drugs & Pharmacology Source Type: research

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience
ConclusionAfter 6  years of post-marketing surveillance, eslicarbazepine acetate maintains a similar safety profile to that observed in pivotal clinical studies. (Source: Drug Safety)
Source: Drug Safety - July 27, 2017 Category: Drugs & Pharmacology Source Type: research

Commercial Online Social Network Data and Statin Side-Effect Surveillance: A Pilot Observational Study of Aggregate Mentions on Facebook
ConclusionsFuture work on pharmacovigilance may be informed by this novel commercial tool, but the inability to mine the full text of a posting poses serious challenges to content categorization. (Source: Drug Safety)
Source: Drug Safety - July 26, 2017 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase
ConclusionWe identified 88 drugs with a significant positive disproportionality for dental caries. Special attention has to be paid to bisphosphonates, atropinic drugs, immunosuppressants and drugs causing hyperglycaemia. (Source: Drug Safety)
Source: Drug Safety - July 25, 2017 Category: Drugs & Pharmacology Source Type: research

Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan
ConclusionsThe period of human papillomavirus vaccination considerably overlapped with that of unique post-vaccination symptom development. Based on these sequential events, it is suggested that human papillomavirus vaccination is related to the transiently high prevalence of the previously mentioned symptoms including chronic regional pain syndrome and autonomic and cognitive dysfunctions in the vaccinated patients. (Source: Drug Safety)
Source: Drug Safety - July 25, 2017 Category: Drugs & Pharmacology Source Type: research

Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system...
Source: Drug Safety - July 22, 2017 Category: Drugs & Pharmacology Source Type: research

The Fetal Safety of Enoxaparin Use During Pregnancy: A Population-Based Retrospective Cohort Study
ConclusionExposure to enoxaparin during pregnancy was not associated with an increased risk of major malformations in general or according to organ systems. Nonetheless, risk for specific malformations cannot be ruled out. (Source: Drug Safety)
Source: Drug Safety - July 21, 2017 Category: Drugs & Pharmacology Source Type: research

Brian A. Baldo, Safety of Biologics Therapy: Monoclonal Antibodies, Cytokines, Fusion Proteins, Hormones, Enzymes, Coagulation Proteins, Vaccines, Botulinum Toxins, 1st Edition, Springer, 2016, Print Book ISBN: 978-3-319-30470-0, e-Book ISBN 978-3-319-30472-4
(Source: Drug Safety)
Source: Drug Safety - July 13, 2017 Category: Drugs & Pharmacology Source Type: research

Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance
ConclusionCase reports of medication errors in EudraVigilance steadily increased between 2005 and 2015, the reasons for which may be multifactorial, including increased awareness, changes to the MedDRA® terminology and the 2012 EU pharmacovigilance legislation and associated guidance for stakeholders, or a generally increased risk for errors as more medications become available. (Source: Drug Safety)
Source: Drug Safety - July 11, 2017 Category: Drugs & Pharmacology Source Type: research

Statin Therapy and Risk of Intracranial Hemorrhage in Patients with Ischemic Stroke
(Source: Drug Safety)
Source: Drug Safety - July 10, 2017 Category: Drugs & Pharmacology Source Type: research

Safety and Interactions of Direct Oral Anticoagulants with Antiarrhythmic Drugs
AbstractDirect oral anticoagulants (DOACs) are novel direct-acting medications that are selective for either thrombin or activated factor X. Due to their obvious benefits for patients (fewer interactions, broader therapeutic window, etc.), they are increasingly used as an alternative to warfarin, phenprocoumon, or acenocoumarol. One of the major indications for use of DOACs is stroke prevention in patients with atrial fibrillation (AF). However, interactions still exist, especially in combination with antiarrhythmic drugs (AADs), which are frequently given to AF patients for rhythm or rate control. These interactions are d...
Source: Drug Safety - July 8, 2017 Category: Drugs & Pharmacology Source Type: research

The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment
ConclusionBased on the patterns of birth defects reported, preliminary findings do not suggest a clear signal of human teratogenicity for ribavirin. However, the current sample size is insufficient for definitive conclusions, and ribavirin exposure should be avoided during pregnancy and during the 6  months prior to pregnancy, in accordance with prescribing information.Clinical Trial RegistrationClinicalTrials.gov identifier: NCT00114712. (Source: Drug Safety)
Source: Drug Safety - July 8, 2017 Category: Drugs & Pharmacology Source Type: research

Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A Disproportionality Analysis Using the Italian National Network of Pharmacovigilance Database
This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database.MethodsA disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016. Reporting odds ratio (ROR) and 95% confidence intervals (CIs) were calculated as a measure of disproportionality. In a secondary and tertiary analysis, we explored the association of PPIs with muscular ADRs after taking into account the masking effect of statins. Moreover, the possibility of an inte...
Source: Drug Safety - July 5, 2017 Category: Drugs & Pharmacology Source Type: research

Comment on “Patient Reporting in the EU: Analysis of EudraVigilance Data”
(Source: Drug Safety)
Source: Drug Safety - July 4, 2017 Category: Drugs & Pharmacology Source Type: research

Clinical Relevance and Predictive Value of Damage Biomarkers of Drug-Induced Kidney Injury
AbstractNephrotoxin exposure accounts for up to one-fourth of acute kidney injury episodes in hospitalized patients, and the associated consequences are as severe as acute kidney injury due to other etiologies. As the use of nephrotoxic agents represents one of the few modifiable risk factors for acute kidney injury, clinicians must be able to identify patients at high risk for drug-induced kidney injury rapidly. Recently, significant advancements have been made in the field of biomarker utilization for the prediction and detection of acute kidney injury. Such biomarkers may have a role both for detection of drug-induced k...
Source: Drug Safety - July 3, 2017 Category: Drugs & Pharmacology Source Type: research

Impact of Medicine Withdrawal on Reporting of Adverse Events Involving Therapeutic Alternatives: A Study from the French Spontaneous Reporting Database
ConclusionFor the three drug withdrawals investigated, the number of case reports involving alternatives increased to a larger extent than the numbers of prescriptions. This could relate to a higher occurrence of AEs in new users of alternatives who switched from the withdrawn medicines or to an increased awareness of possible AEs. (Source: Drug Safety)
Source: Drug Safety - June 29, 2017 Category: Drugs & Pharmacology Source Type: research

Using Multiple Pharmacovigilance Models Improves the Timeliness of Signal Detection in Simulated Prospective Surveillance
ConclusionsSimulation results indicate that, if the true model isnot known, an association can be detected in a more timely manner by first fitting a carefully selected set of exposure –risk models and then generating a signal as soon as any of the models considered yields a test statistic value below a predetermined testing threshold. (Source: Drug Safety)
Source: Drug Safety - June 29, 2017 Category: Drugs & Pharmacology Source Type: research

Signal of Miscarriage with Aripiprazole: A Disproportionality Analysis of the Japanese Adverse Drug Event Report Database
ConclusionThrough our analysis of the Japanese Adverse Drug Event Report database, we found a potential signal for miscarriage for aripiprazole. Safety information on the use of aripiprazole during pregnancy is very limited. Therefore, we suggest that the potential signal detected in our analysis be explored further. (Source: Drug Safety)
Source: Drug Safety - June 29, 2017 Category: Drugs & Pharmacology Source Type: research

Good Intentions, But What About Unintended Consequences?
(Source: Drug Safety)
Source: Drug Safety - June 28, 2017 Category: Drugs & Pharmacology Source Type: research

Patients ’ Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana
ConclusionPatients have a positive attitude and good knowledge on adverse drug reaction reporting to the National Pharmacovigilance Centre and report because they expect extra information and to contribute to drug safety. Patients ’ positive attitude towards adverse drug reaction reporting could be sustained by hosting periodic public awareness campaigns addressing the importance of adverse drug reaction reporting and by providing timely feedback to patients on regulatory decisions taken as a result of the reports that they submitted. (Source: Drug Safety)
Source: Drug Safety - June 26, 2017 Category: Drugs & Pharmacology Source Type: research

Natural Language Processing for EHR-Based Pharmacovigilance: A Structured Review
This article is a comprehensive structured review of recent advances in applying natural language processing (NLP) to electronic health record (EHR) narratives for pharmacovigilance. We review methods of varying complexity and problem focus, summarize the current state-of-the-art in methodology advancement, discuss limitations and point out several promising future directions. The ability to accurately capture both semantic and syntactic structures in clinical narratives becomes increasingly critical to enable efficient and accurate ADE detection. Significant progress has been made in algorithm development and resource con...
Source: Drug Safety - June 22, 2017 Category: Drugs & Pharmacology Source Type: research

Association of Parkinsonism or Parkinson Disease with Polypharmacy in the Year Preceding Diagnosis: A Nested Case –Control Study in South Korea
ConclusionsPolypharmacy in the year preceding diagnosis may be associated with an increased risk for parkinsonism/Parkinson disease. Medications potentially associated with parkinsonism were assumed to increase the risk for parkinsonism/Parkinson disease, but more studies are required to confirm this relationship. (Source: Drug Safety)
Source: Drug Safety - June 20, 2017 Category: Drugs & Pharmacology Source Type: research

Updating the Evidence of the Interaction Between Clopidogrel and CYP2C19-Inhibiting Selective Serotonin Reuptake Inhibitors: A Cohort Study and Meta-Analysis
ConclusionsWe observed similar estimates of association between the two studies. The updated evidence still indicates a small decrease in clopidogrel effectiveness associated with concomitant exposure to clopidogrel and CYP2C19-inhibiting SSRIs. (Source: Drug Safety)
Source: Drug Safety - June 16, 2017 Category: Drugs & Pharmacology Source Type: research

Lipophilic Statins and the Risk of Intracranial Hemorrhage Following Ischemic Stroke: A Population-Based Study
ConclusionAmong patients treated with a statin following ischemic stroke, the risk of intracranial hemorrhage is not influenced by statin lipophilicity. (Source: Drug Safety)
Source: Drug Safety - June 15, 2017 Category: Drugs & Pharmacology Source Type: research

Occurrence of Multiple Sclerosis After Drug Exposure: Insights From Evidence Mapping
ConclusionA heterogeneous pharmacological profile of identified classes emerged. Low strength of evidence and conflicting results highlighted the difficulties in addressing the possible contribution of drugs in MS occurrence. Methodological advances are needed, especially to control the confounding role of underlying disease for specific drug classes. (Source: Drug Safety)
Source: Drug Safety - June 9, 2017 Category: Drugs & Pharmacology Source Type: research

An Algorithm to Identify Generic Drugs in the FDA Adverse Event Reporting System
ConclusionsThe algorithm demonstrated high inter-rater reliability with moderate internal consistency for identifying generic drugs in the FAERS, in our sample. Future efforts should focus on improving the reliability and validity of identifying generics through improving the completeness of reporting in the FAERS. (Source: Drug Safety)
Source: Drug Safety - June 7, 2017 Category: Drugs & Pharmacology Source Type: research

Overview of the Safety of Anti-VEGF Drugs: Analysis of the Italian Spontaneous Reporting System
AbstractIntroductionAnti-vascular endothelial growth factor (anti-VEGF) drugs are widely used for the treatment of several cancers and retinal diseases. The systemic use of anti-VEGF drugs has been associated with an increased risk of serious adverse reactions. Whether this risk is also related to intravitreal administration of anti-VEGF drugs is unclear.ObjectiveThe aim of this study was to provide an overview of the safety of anti-VEGF drugs in oncology and ophthalmology settings using the Italian Spontaneous Reporting System (SRS).MethodsWe selected all suspected adverse drug reaction (ADR) reports attributed to anti-VE...
Source: Drug Safety - June 5, 2017 Category: Drugs & Pharmacology Source Type: research

Second-Generation Antipsychotics and Metabolic Side Effects: A Systematic Review of Population-Based Studies
DiscussionPopulation-based evidence for other SGAs and metabolic outcomes was limited. However, clozapine and olanzapine were consistently more strongly associated with metabolic adverse events than were other SGAs currently available. (Source: Drug Safety)
Source: Drug Safety - June 5, 2017 Category: Drugs & Pharmacology Source Type: research

Using Simulated Data to Assess Case-Crossover Designs for Studying Less Transient Effects of Drugs
(Source: Drug Safety)
Source: Drug Safety - June 3, 2017 Category: Drugs & Pharmacology Source Type: research

The Power of the Case Narrative  - Can it be Brought to Bear on Duplicate Detection?
(Source: Drug Safety)
Source: Drug Safety - May 30, 2017 Category: Drugs & Pharmacology Source Type: research

The Incidence of Drug- and Herbal and Dietary Supplement-Induced Liver Injury: Preliminary Findings from Gastroenterologist-Based Surveillance in the Population of the State of Delaware
ConclusionProspective, gastroenterologist-based surveillance for suspected DILI in Delaware yielded an incidence of 2.7 cases per 100,000 adults in 2014; this is the first prospective estimate of DILI for the USA. Because surveillance was limited to subspecialists, the actual incidence of DILI is likely to be higher. These findings provide a benchmark statistic for the epidemiology of DILI in the United States, to be refined with expansion of the surveillance period. (Source: Drug Safety)
Source: Drug Safety - May 29, 2017 Category: Drugs & Pharmacology Source Type: research

Potential Teratogenic Effects of Clomiphene Citrate
AbstractClomiphene citrate (CC) is the oldest drug used to regulate the process of ovulation. Considering the great use of CC over the last 40  years, it is important to understand the possible risks associated with its use. The aim of this review was to evaluate the possible teratogenic effects of CC, analyzing results obtained from animal and human studies. The pharmacokinetics of CC and possible mechanisms involved in teratogenesis are examined. Fetal exposure to CC is possible due to the long half-life of CC and its metabolites. Alarming data have emerged from animal studies, although controversial results come fr...
Source: Drug Safety - May 25, 2017 Category: Drugs & Pharmacology Source Type: research

Communication on Safety of Medicines in Europe: Current Practices and General Practitioners ’ Awareness and Preferences
ConclusionsNCAs use similar methods for safety communications on medicines. Most GPs were aware of urgent communications and preferred similar senders of safety communications; however, their preferences towards the format differed per country. (Source: Drug Safety)
Source: Drug Safety - May 24, 2017 Category: Drugs & Pharmacology Source Type: research

The New Phase of ISoP
(Source: Drug Safety)
Source: Drug Safety - May 22, 2017 Category: Drugs & Pharmacology Source Type: research