Safety and Tolerability of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors in Oncology
AbstractTyrosine kinase inhibitors (TKIs) that target epidermal growth factor receptor (EGFR) have dramatically improved progression-free survival in non-small-cell lung cancer (NSCLC) patients who carry sensitizing EGFR-activating mutations and in patients with breast and pancreatic cancers. However, EGFR-TKIs are associated with significant and disabling undesirable effects that adversely impact on quality of life and compliance. These effects include dermatological reactions, diarrhoea, hepatotoxicity, stomatitis, interstitial lung disease and ocular toxicity. Each individual EGFR-TKI is also associated with additional ...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Histone Deacetylase (HDAC) Inhibitors in Oncology
AbstractHistone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently approved under various jurisdictions, namely belinostat, chidamide, panobinostat, romidepsin and vorinostat. These agents are associated with a range of class-related and agent-specific serious and/or severe adverse effects, notably myelosuppression, diarrhoea and various cardiac effects. Among the cardiac...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Phosphatidylinositol-3-Kinase (PI3K) Inhibitors in Oncology
AbstractActivation of phosphatidylinositol-3-kinase (PI3K) and downstream signalling by AKT/mammalian target of rapamycin (mTOR) modulates cellular processes such as increased cell growth, cell proliferation and increased cell migration as well as deregulated apoptosis and oncogenesis. The PI3K/AKT/mTOR pathway (particularly Class  I PI3K isoforms) is frequently activated in a variety of solid tumours and haematological malignancies, making PI3K an attractive therapeutic target in oncology. Inhibitors of PI3K also have the potential to restore sensitivity to other modalities of treatments when administered as part of ...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Antibody-Drug Conjugates in Cancer
AbstractAntibody-drug conjugates are monoclonal antibodies attached to biologically active drugs through chemical linkers that deliver and release cytotoxic agents at the tumor site, reducing the likelihood of systemic exposure and therefore toxicity. Currently, there are about 110 ongoing studies implementing antibody-drug conjugates in the treatment of multiple human malignancies. Antibody-drug conjugates carry a feature of the specificity of a monoclonal antibody and the anti-neoplastic potential of a cytotoxin. The first antibody-drug conjugate was approved in 2001, and the field of antibody-drug conjugates has expande...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer
AbstractThe chimeric protein echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase, resulting from the rearrangement of the homonym genes, is one of the currently targetable oncogenic drivers in anaplastic lymphoma kinase-positive non-small-cell lung cancer. In fact, four first- and second-generation anaplastic lymphoma kinase tyrosine kinase inhibitors, crizotinib (PF-02341066), ceritinib (LDK378), alectinib (CH5424802), and brigatinib (AP26113), are presently approved for clinical practice; however, these agents are not devoid of complications and thus should be administered meaningfully. Furthermor...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Events Detection in Clinical Notes by Jointly Modeling Entities and Relations Using Neural Networks
ConclusionIt is important to use joint modeling techniques and external resources for effectively detecting ADEs from clinical narratives in electronic health record (EHR) systems. While the extraction of entities and relations individually achieved high accuracy, the integrated task still has room for further improvement. (Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Event Detection from Electronic Health Records Using Hierarchical Recurrent Neural Networks with Dual-Level Embedding
ConclusionOur results indicate that the integration of two widely used sequence labeling techniques that complement each other along with dual-level embedding (character level and word level) to represent words in the input layer results in a deep learning architecture that achieves excellent information extraction accuracy for EHR notes. (Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Sonic Hedgehog Pathway Inhibitors in Cancer
AbstractThe hedgehog pathway, for which sonic hedgehog (Shh) is the most prominent ligand, is highly conserved and is tightly associated with embryonic development in a number of species. This pathway is also tightly associated with the development of several types of cancer, including basal cell carcinoma (BCC) and acute promyelocytic leukemia, among many others. Inactivating mutations in Patched-1 (PTCH1), leading to ligand-independent pathway activation, are frequent in several cancer types, but most prominent in BCC. This has led to the development of several compounds targeting this pathway as a cancer therapeutic. Th...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of c-MET Inhibitors in Cancer
AbstractThe role of aberrant hepatocyte growth factor receptor (c-MET, also known as tyrosine-protein kinase MET)/hepatocyte growth factor (HGF) signaling in cancer progression and invasion has been extensively studied. c-MET inhibitors have shown promising pre-clinical and early phase clinical trial anti-tumor activity in several tumor types, although results of most phase III trials with these agents have been negative. To date, two small molecule c-MET inhibitors, cabozantinib and crizotinib, have been approved by regulatory authorities for the treatment of selected cancer types, but several novel c-MET inhibitors (eith...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Benefit –Risk Assessment of Plecanatide in the Treatment of Chronic Idiopathic Constipation
AbstractPlecanatide, a uroguanylin analog, activates the guanylate cyclase C receptors in the epithelial lining of the gastrointestinal tract in a pH-dependent fashion initiating (1) the conversion of intracellular guanosine triphosphate to cyclic guanosine monophosphate, which increases the activity of the cystic fibrosis transmembrane conductance regulator to increase chloride and bicarbonate secretion into the intestinal lumen and (2) a decrease in activity of the sodium-hydrogen ion exchanger. The resulting ionic shifts cause an increase in lumenal fluid to facilitate digestion. Plecanatide has been approved by the FDA...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Immune Checkpoint Inhibitors (PD-1 and PD-L1) in Cancer
AbstractImmunotherapy has emerged in recent years and has revolutionized the treatment of cancer. Immune checkpoint inhibitors, including anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-programmed cell death-1 (PD-1) and anti-programmed cell death ligand-1 (PD-L1) agents, are the first of this new generation of treatments. Anti-PD-1/PD-L1 agents target immune cells by blocking the PD-1/PD-L1 pathway. This blockade leads to enhancement of the immune system and therefore restores the tumour-induced immune deficiency selectively in the tumour microenvironment. However, this shift in the balance of the immune system can a...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance
ConclusionCVAD had a high coverage of ADRs and integrated standard controlled vocabularies to the EHR data sources, and researchers can take advantage of these features for EHR observational data-based extensive pharmacovigilance studies to improve sensitivity and specificity. (Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Adoptive Cell Therapy in Cancer
AbstractAdoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T  cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] engineered T cells) to mediate cancer rejection. In recent years, some ACTs have produced unprecedented breakthrough responses: TIL therapy has moved from melanoma to solid tumor a pplications, TCR-engineered cells are developed for hematologic and solid tumors, and CAR-engineered T cells have ...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Detecting Adverse Drug Events with Rapidly Trained Classification Models
ConclusionAdding to the growing number of publications that  utilize NLP to detect occurrences of ADEs, our study illustrates the benefits of employing innovative feature engineering. (Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety and Tolerability of Anti-Angiogenic Protein Kinase Inhibitors and Vascular-Disrupting Agents in Cancer: Focus on Gastrointestinal Malignancies
AbstractAngiogenesis is an essential process for tumor growth and metastasis. Inhibition of angiogenesis as an anticancer strategy has shown significant results in a plethora of tumors. Anti-angiogenic agents are currently part of many standard-of-care options for several metastatic gastrointestinal cancers. Bevacizumab, aflibercept, ramucirumab, and regorafenib have significantly improved both progression-free and overall survival in different lines of treatment in metastatic colorectal cancer. Second-line ramucirumab and third-line apatinib are effective anti-angiogenic treatments for patients with metastatic gastric can...
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Safety of Novel Targeted Therapies in Oncology
(Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma
ConclusionPreclinical assessments suggested a low likelihood of immunogenicity for tralokinumab. In STRATOS  1 and 2, ADA incidence was low, no differences were found between tralokinumab-treated and placebo groups in reporting of hypersensitivity reactions, and there were no Sampson criteria-evaluated anaphylaxis events with tralokinumab treatment. Together, the results suggest that tralokinumab treatme nt would not increase the risk for severe hypersensitivity or anaphylactic reactions. (Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Overview of the First Natural Language Processing Challenge for Extracting Medication, Indication, and Adverse Drug Events from Electronic Health Record Notes (MADE 1.0)
ConclusionMADE results show that recent progress in NLP has led to remarkable improvements in NER and RI tasks for the clinical domain. However, some room for improvement remains, particularly in the NER-RI task. (Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Towards Drug Safety Surveillance and Pharmacovigilance: Current Progress in Detecting Medication and Adverse Drug Events from Electronic Health Records
(Source: Drug Safety)
Source: Drug Safety - January 16, 2019 Category: Drugs & Pharmacology Source Type: research

Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance
(Source: Drug Safety)
Source: Drug Safety - January 13, 2019 Category: Drugs & Pharmacology Source Type: research

All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study
ConclusionOverall, there was an increased mortality risk associated with tramadol in the adult population. However, as residual confounding cannot be completely removed in large observational studies, this must be carefully interpreted in the decision-making regarding patient care. (Source: Drug Safety)
Source: Drug Safety - January 10, 2019 Category: Drugs & Pharmacology Source Type: research

Identifying Data Elements to Measure Frailty in a Dutch Nationwide Electronic Medical Record Database for Use in Postmarketing Safety Evaluation: An Exploratory Study
AbstractIntroductionThe role of frailty in postmarketing drug safety is increasingly acknowledged. Few European electronic medical records (EMRs) have been used to explore frailty in observational drug safety research.ObjectiveThe aim of this study was to identify data elements, beyond multimorbidity and polypharmacy, that could potentially contribute to measuring frailty among older adults in the Dutch nationwide Integrated Primary Care Information (IPCI) database.MethodsPersons aged between 65 and 90  years in the IPCI database were identified from 2008 to 2013. Clinical non-disease, non-drug measurements that could...
Source: Drug Safety - January 8, 2019 Category: Drugs & Pharmacology Source Type: research

Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study
ConclusionDepression and suicidal ideation and behavior are seen in patients using mAbs, particularly mAbs used for treating autoimmune diseases that suppress the immune system. For interpretation of these data, the indications for use and other characteristics require further consideration. (Source: Drug Safety)
Source: Drug Safety - January 8, 2019 Category: Drugs & Pharmacology Source Type: research

An Implementation and Visualization of the Tree-Based Scan Statistic for Safety Event Monitoring in Longitudinal Electronic Health Data
The objective of this analysis was to identify and visualize SDRs with the TBSS in historical data from patients using two antifungal drugs, itraconazole or terbinafine. By examining patients who used either itraconazole or terbinafine, we provide a conceptual replication of a previous TBSS analyses by varying methodological choices and using a data source that had not been previously used with the TBSS, i.e., the Optum Clinformatics ™ claims database. With this analysis, we aimed to test a parsimonious design that could be the basis of a broadly applicable method for multiple drug and safety event pairs.MethodsThe T...
Source: Drug Safety - January 8, 2019 Category: Drugs & Pharmacology Source Type: research

Managing Risks with Immune Therapies in Multiple Sclerosis
AbstractSince the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heterogeneous group of therapeutics comprising recombinant pegylated and non-pegylated interferon- β variants, peptide combinations, monoclonal antibodies, and small molecules. However, they have relevant side effect profiles, which necessitate thorough monitoring and straightforward patient education. In...
Source: Drug Safety - January 3, 2019 Category: Drugs & Pharmacology Source Type: research

MADEx: A System for Detecting Medications, Adverse Drug Events, and Their Relations from Clinical Notes
ConclusionThis study demonstrated the efficiency of deep learning methods for automatic extraction of medications, ADEs, and their relations from clinical text to support pharmacovigilance and drug safety surveillance. (Source: Drug Safety)
Source: Drug Safety - January 2, 2019 Category: Drugs & Pharmacology Source Type: research

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance
This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection.MethodsIndividual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, out...
Source: Drug Safety - December 19, 2018 Category: Drugs & Pharmacology Source Type: research

Benefit –Risk Assessment of Blinatumomab in the Treatment of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
AbstractBlinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-negative (Ph −) relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL) and B-cell precursor ALL with minimal residual disease. Similarly, initial marketing authorization for blinatumomab in the European Union was granted for the treatment of adults with Ph− R/R B-c...
Source: Drug Safety - December 18, 2018 Category: Drugs & Pharmacology Source Type: research

Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives
(Source: Drug Safety)
Source: Drug Safety - December 18, 2018 Category: Drugs & Pharmacology Source Type: research

Evaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase ™ between 2014 and 2017
ConclusionsFindings suggest that iron (III) isomaltoside 1000 is associated with a higher reporting rate of severe HSRs related to estimated exposure than ferric carboxymaltose in European countries. Future research investigating the occurrence of severe HSRs associated with i.v. ferric carboxymaltose and iron (III) isomaltoside 1000 is needed to broaden the evidence for benefit-risk assessment. (Source: Drug Safety)
Source: Drug Safety - December 10, 2018 Category: Drugs & Pharmacology Source Type: research

Evaluation of Harm Associated with High Dose-Range Clinical Decision Support Overrides in the Intensive Care Unit
AbstractIntroductionMedication-related clinical decision support (CDS) alerts have been shown to be effective at reducing adverse drug events (ADEs). However, these alerts are frequently overridden, with limited data linking these overrides to harm. Dose-range checking alerts are a type of CDS alert that could have a significant impact on morbidity and mortality, especially in the intensive care unit (ICU) setting.MethodsWe performed a single-center, prospective, observational study of adult ICUs from September 2016 to April 2017. Targeted overridden alerts were triggered when doses greater than or equal to 5% over the max...
Source: Drug Safety - December 1, 2018 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Cohen et al.’s Comment on “Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database”
(Source: Drug Safety)
Source: Drug Safety - November 8, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on “Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database”
(Source: Drug Safety)
Source: Drug Safety - November 8, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Abstracts of the 18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018
ISoP18-1156 From Database to Diagnosis: ‘Intelligent Query’, a Tool to Help With Safety Signal Evaluation” (Source: Drug Safety)
Source: Drug Safety - October 31, 2018 Category: Drugs & Pharmacology Source Type: research

Fluoroquinolones and Cardiovascular Risk: A Systematic Review, Meta-analysis and Network Meta-analysis
ConclusionsOur findings show a significant association between fluoroquinolone use and an increased risk for arrhythmia and cardiovascular mortality. Moxifloxacin ranked with the highest probability for cardiovascular adverse events. Further study is required to determine how to reduce the risk for fluoroquinolone-associated cardiac toxicity. (Source: Drug Safety)
Source: Drug Safety - October 27, 2018 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - October 27, 2018 Category: Drugs & Pharmacology Source Type: research

Previous Drug Exposure in Patients Hospitalised for Acute Liver Injury: A Case-Population Study in the French National Healthcare Data System
ConclusionsThis nationwide study describes drugs associated with ALI, according to absolute population burden and per-patient and per-tablet risk. Some of these associations may be spurious, others causal, and others yet were unexpected. Systematic analysis of drug classes will look for outliers within each class that could raise signals of unexpected hepatic toxicity. (Source: Drug Safety)
Source: Drug Safety - October 25, 2018 Category: Drugs & Pharmacology Source Type: research

The Role of European Patient Organizations in Pharmacovigilance
ConclusionBringing pharmacovigilance stakeholders and patient organizations together could create a more optimal reporting culture. Patient organizations appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. Lack of resources, budget, and support from NCAs are seen as the main barriers to being involved in pharmacovigilance awareness. (Source: Drug Safety)
Source: Drug Safety - October 24, 2018 Category: Drugs & Pharmacology Source Type: research

Prevalence of Drug Prescriptions and Potential Safety in Patients with Cirrhosis: A Retrospective Real-World Study
ConclusionsPatients with cirrhosis use a large number of drugs. Almost two-thirds of patients in our cohort used potentially unsafe drugs. To prevent ADRs in these frail patients, personalised pharmacotherapy is necessary. (Source: Drug Safety)
Source: Drug Safety - October 24, 2018 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Liver Injury: Highlights of the Recent Literature
AbstractDrug-induced liver injury (DILI), herbal-induced liver injury, and herbal and dietary supplement (HDS)-induced liver injury are an important aspect of drug safety. Knowledge regarding responsible drugs, mechanisms, risk factors, and the diagnostic tools to detect liver injury have continued to grow in the past year. This review highlights what we considered the most significant publications from among more than 1800 articles relating to liver injury from medications, herbal products, and dietary supplements in 2017 and 2018. The US Drug-Induced Liver Injury Network (DILIN) prospective study highlighted several area...
Source: Drug Safety - October 20, 2018 Category: Drugs & Pharmacology Source Type: research

Artificial Intelligence and the Future of the Drug Safety Professional
The objective of the research was to understand the thoughts of pharmacovigilance professionals about their jobs. These results are provided in the form of aggregated responses to interview questions based on a 12-part questionnaire [see the Electronic Supplementary Material (ESM)]. A sample of six DS professionals representing various areas of pharmacovigilance operations were asked a range of questions about their backgrounds, current roles and future expectations. The DS professionals interviewed were, overall, enthusiastic about their job role s potentially changing with AI enhancements. Interviewees suggested that AI ...
Source: Drug Safety - October 20, 2018 Category: Drugs & Pharmacology Source Type: research

Safety of Follitropin Alfa/Lutropin Alfa for Stimulation of Follicular Development
ConclusionCumulative reporting rates of important identified and potential risks of r-hFSH/r-hLH during a 10-year surveillance period demonstrate the benefit –risk balance is positive. This post-marketing surveillance and continued surveillance of safety events should provide reassurance about the use of r-hFSH/r-hLH in clinical practice. (Source: Drug Safety)
Source: Drug Safety - October 19, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on “Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project”
(Source: Drug Safety)
Source: Drug Safety - October 19, 2018 Category: Drugs & Pharmacology Source Type: research

Correction to: Liver Safety of Fasiglifam (TAK-875) in Patients with Type 2 Diabetes: Review of the Global Clinical Trial Experience
In the original publication of the article, the ALT and AST values in Fig.  5a–e were capped at 10× ULN, which did not accurately reflect the narrative provided for each case. In this correction, the original Fig. 5a–e (Fig. 1a–e) and the correct Fig. 5a–5e (Fig. 2a–e) are published. (Source: Drug Safety)
Source: Drug Safety - October 17, 2018 Category: Drugs & Pharmacology Source Type: research

Real World Evidence: Time for a Switch?
(Source: Drug Safety)
Source: Drug Safety - October 9, 2018 Category: Drugs & Pharmacology Source Type: research

Preventing Future Deaths from Medicines: Responses to Coroners ’ Concerns in England and Wales
ConclusionsCoroners ’ concerns are often of national importance but are not currently shared nationally. Only a minority of responses to coroners’ reports concerning medicines are in the public domain. Processes for auditing responses and assessing their effectiveness are opaque. Few of the responses appear to prov ide robust and generally applicable ways to prevent future deaths. (Source: Drug Safety)
Source: Drug Safety - October 8, 2018 Category: Drugs & Pharmacology Source Type: research

18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018
(Source: Drug Safety)
Source: Drug Safety - October 5, 2018 Category: Drugs & Pharmacology Source Type: research

Comment on “Using Human ‘Experiments of Nature’ to Predict Drug Safety Issues: An Example with PCSK9 Inhibitors”
(Source: Drug Safety)
Source: Drug Safety - October 5, 2018 Category: Drugs & Pharmacology Source Type: research

Role of Serotonin Transporter in Antidepressant-Induced Diabetes Mellitus: A Pharmacoepidemiological –Pharmacodynamic Study in VigiBase ®
ConclusionThe present study suggests a potential role for serotonin transporter in antidepressant-induced type 2 diabetes. (Source: Drug Safety)
Source: Drug Safety - October 5, 2018 Category: Drugs & Pharmacology Source Type: research

Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample
ConclusionsThere was no evidence for an increased risk of ACS in patients dispensed ibuprofen compared to paracetamol. (Source: Drug Safety)
Source: Drug Safety - October 5, 2018 Category: Drugs & Pharmacology Source Type: research