Cancer Event Rate and Mortality with Thienopyridines: A Systematic Review and Meta-Analysis
ConclusionsOur results suggest that there is currently insufficient evidence to suggest that thienopyridine exposure is associated with an increased risk of cancer event rate or mortality. (Source: Drug Safety)
Source: Drug Safety - December 29, 2016 Category: Drugs & Pharmacology Source Type: research

Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases
AbstractIntroductionAntibiotics are the most commonly prescribed drug class in children. Real-world data mining on the paediatric population showed potential associations between antibiotic use and acute liver injury.ObjectiveWe assessed risk estimates of liver injury associated with antibiotic use in children and adolescent outpatients.MethodsA large, multi-database, population-based, case-control study was performed in people
Source: Drug Safety - December 26, 2016 Category: Drugs & Pharmacology Source Type: research

Diverging Conclusions from the Same Meta-Analysis in Drug Safety: Source of Data (Primary Versus Secondary) Takes a Toll
ConclusionsThe results after stratification are considerably modified. It is crucial to explore the origin of the data, either primary or secondary, as a source of heterogeneity in pharmacoepidemiologic meta-analyses to avoid misleading conclusions. (Source: Drug Safety)
Source: Drug Safety - December 22, 2016 Category: Drugs & Pharmacology Source Type: research

The Impact of Provider Networks on the Co-Prescriptions of Interacting Drugs: A Claims-Based Analysis
AbstractIntroductionMultiple provider prescribing of interacting drugs is a preventable cause of morbidity and mortality, and fragmented care is a major contributing factor. We applied social network analysis to examine the impact of provider patient-sharing networks on the risk of multiple provider prescribing of interacting drugs.MethodsWe performed a retrospective analysis of commercial healthcare claims (years 2008 –2011), including all non-elderly adult beneficiaries (n = 88,494) and their constellation of care providers. Patient-sharing networks were derived based on shared patients, and care constell...
Source: Drug Safety - December 20, 2016 Category: Drugs & Pharmacology Source Type: research

Hepatic Cyst Infection During Use of the Somatostatin Analog Lanreotide in Autosomal Dominant Polycystic Kidney Disease: An Interim Analysis of the Randomized Open-Label Multicenter DIPAK-1 Study
We describe these events and provide a review of the literature.MethodsThe DIPAK-1 Study is an ongoing investigator-driven, randomized, controlled, open-label multicenter trial. Patients (ADPKD, ages 18 –60 years, estimated glomerular filtration rate 30–60 mL/min/1.73 m2) were randomized 1:1 to receive lanreotide 120  mg subcutaneously every 28 days or standard care during 120 weeks. Hepatic cyst infection was diagnosed by local physicians.ResultsWe included 309 ADPKD patients of which seven (median age 53  years [interquartile range: 48–55], 71% female, median estimated...
Source: Drug Safety - December 19, 2016 Category: Drugs & Pharmacology Source Type: research

Effect of Medications for Gastric Acid-Related Symptoms on Total Motile Sperm Count and Concentration: A Case –Control Study in Men of Subfertile Couples from the Netherlands
AbstractIntroductionGastric acid-related symptoms are highly prevalent in the general population (21 –40%), and more than 11% of individuals use medication for the treatment of these symptoms. The uptake of micronutrients is dependent on the gastrointestinal potential of hydrogen (pH).ObjectiveWe hypothesized that medication affecting gastrointestinal pH reduces the availability of B vitamins, thereby deranging one-carbon metabolism and detrimentally affecting spermatogenesis.MethodsThis explorative nested case –control study in men of subfertile couples investigated associations between medication used for gas...
Source: Drug Safety - December 19, 2016 Category: Drugs & Pharmacology Source Type: research

Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010 –May 2016
ConclusionAs in 2009 –2010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010–2016. (Source: Drug Safety)
Source: Drug Safety - December 17, 2016 Category: Drugs & Pharmacology Source Type: research

Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France
AbstractIntroductionOff-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the ‘Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine’ (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence.ObjectiveThe aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provi...
Source: Drug Safety - December 17, 2016 Category: Drugs & Pharmacology Source Type: research

Hyperglycaemia Induced by Novel Anticancer Agents: An Undesirable Complication or a Potential Therapeutic Opportunity?
AbstractSignalling pathways involving protein kinase, insulin-like growth factor 1, insulin receptors and the phosphoinositide 3 kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) system are critical in promoting oncogenesis. The use of anticancer agents that inhibit these pathways frequently results in hyperglycaemia, an on-target effect of these drugs. Hyperglycaemia induced by these agents denotes optimal inhibition of the desired pharmacological target. As hyperglycaemia can be treated successfully and effectively with metformin, managing this complication by reducing the dose of or discontinuing the...
Source: Drug Safety - December 15, 2016 Category: Drugs & Pharmacology Source Type: research

Melanoma and Non-Melanoma Skin Cancer Associated with Angiotensin-Converting-Enzyme Inhibitors, Angiotensin-Receptor Blockers and Thiazides: A Matched Cohort Study
ConclusionsA safety signal for ACEIs, ARBs, and TZs and BCC and SCC, as well as for TZs and MM, was detected. An increased awareness and education, especially for those who are at high risk for skin cancer, are warranted for patients and healthcare providers. Further exploration of such associations for these commonly used drug classes is warranted. (Source: Drug Safety)
Source: Drug Safety - December 9, 2016 Category: Drugs & Pharmacology Source Type: research

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines
AbstractRecent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit –risk monitoring of these devices throughout their entire life cycle. A literature ...
Source: Drug Safety - December 7, 2016 Category: Drugs & Pharmacology Source Type: research

Benefits and Risks of Long-Term Asthma Management in Children: Where Are We Heading?
AbstractInternational guidelines provide recommendations for a stepwise approach to the management of asthma in children 0 –4 years old, 5–11 years old, and adolescents who are treated as adults. Therapy is aimed at two domains of control: current impairment and future risk. The long-term controller medications, inhaled corticosteroids (ICSs), ICSs in combination with long-acting β2 agonists, leukotriene receptor antagonists, and immunomodulators, exhibit different efficacies for these domains. The risk:benefit ratios of the available medications need to be carefully assessed. This review briefly presents ...
Source: Drug Safety - December 7, 2016 Category: Drugs & Pharmacology Source Type: research

Propensity Score Weighting Compared to Matching in a Study of Dabigatran and Warfarin
ConclusionsIn this example, different applications of the same PS led to substantially different results, a finding that was particularly apparent with IPTW, and this was remedied by truncating extreme weights. If IPTW is used, information regarding the weights applied along with sensitivity analyses could avoid misrepresentation of study results, and would enhance their interpretation. (Source: Drug Safety)
Source: Drug Safety - November 29, 2016 Category: Drugs & Pharmacology Source Type: research

Should Domperidone be Used as a Galactagogue? Possible Safety Implications for Mother and Child
AbstractDomperidone has been used as a galactagogue; however, solid evidence from an adequate sized randomized clinical trial is missing. Optimal dosage, start of treatment, length of treatment and scope of patients who can benefit also remain unknown. Although milk obtained after domperidone administration has not been shown to have untoward effects on newborns, no sufficiently large randomized clinical trial has been done to establish safety. Domperidone has repeatedly been shown to produce sudden cardiac death, starting at 30  mg/day. Because of this known cardiac effect, the use of domperidone to increase breast m...
Source: Drug Safety - November 29, 2016 Category: Drugs & Pharmacology Source Type: research

Investigating the Additive Interaction of QT-Prolonging Drugs in Older People Using Claims Data
The objective of this study was to investigate the potential additive risk for ventricular arrhythmia with concomitant prescriptions of QT-prolonging drugs.MethodsClaims data for persons aged ≥65 years between 2010 and 2012 in Germany were analyzed and all cases hospitalized for ventricular arrhythmia were selected. In a case-crossover analysis, exposure with QT-prolonging drugs according to the Arizona Center for Education and Research on Therapeutics (AZCERT) classification of ‘kn own,’ ‘conditional,’ and ‘possible’ TdP risk was determined in respective event and control window...
Source: Drug Safety - November 29, 2016 Category: Drugs & Pharmacology Source Type: research

The Risk of Adverse Pregnancy Outcome After First Trimester Exposure to H1 Antihistamines: A Systematic Review and Meta-Analysis
AbstractIntroductionH1 antihistamines are used for the treatment of nausea and vomiting during pregnancy as well as the symptomatic relief of asthma, urticaria, allergy, and the common cold. Although they are overall felt to be safe during pregnancy, recently several studies have challenged this assumption, as millions of women are exposed to them in the first trimester.MethodsFollowing the guidelines of PRISMA, a systematic review was performed to retrieve all published articles involving H1-antihistamine exposure during pregnancy. Electronic databases including PubMed and EMBASE were searched for possibly relevant articl...
Source: Drug Safety - November 22, 2016 Category: Drugs & Pharmacology Source Type: research

On the Potential of Preemptive Genotyping Towards Preventing Medication-Related Adverse Events: Results from the South Korean National Health Insurance Database
(Source: Drug Safety)
Source: Drug Safety - November 21, 2016 Category: Drugs & Pharmacology Source Type: research

The Harms of Antipsychotic Drugs: Evidence from Key Studies
AbstractThis safety assessment provides a detailed analysis of key studies and focuses on the six most widely used antipsychotic drugs. Lines of evidence include mechanisms of action, short-term treatment of psychosis, relapse prevention, early intervention in schizophrenia, long-term comparisons between first- and second-generation agents, and flexible treatment algorithms. Despite the diversity of study settings, several common features were seen. All the agents obstruct normal signaling through widely dispersed dopamine D2 receptors. Treatment failure or psychosis relapse was the most frequent outcome in most key studie...
Source: Drug Safety - November 19, 2016 Category: Drugs & Pharmacology Source Type: research

The Role of Hemoglobin Laboratory Test Results for the Detection of Upper Gastrointestinal Bleeding Outcomes Resulting from the Use of Medications in Observational Studies
ConclusionsUsing available hemoglobin result values combined with non-inpatient UGI diagnoses identified few additional UGI cases. Non-inpatient UGI diagnostic codes may increase outcome detection but would require validation. (Source: Drug Safety)
Source: Drug Safety - November 15, 2016 Category: Drugs & Pharmacology Source Type: research

Vancomycin-Induced Thrombocytopenia: A Narrative Review
AbstractThrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancomycin. Biomedical databases including ‘PubMed’, ‘Scopus’, and ‘Web of Science’ were searched using terms ‘vancomycin’, ‘platelet’, ‘pancytopenia’, ‘thrombocytopenia’, and ‘bleeding’. English language articles...
Source: Drug Safety - November 15, 2016 Category: Drugs & Pharmacology Source Type: research

Treatment-Related Progressive Multifocal Leukoencephalopathy in Multiple Sclerosis: A Comprehensive Review of Current Evidence and Future Needs
AbstractProgressive multifocal leukoencephalopathy (PML) is a rare opportunistic infection of the central nervous system caused by the John Cunningham virus (JCV) that has been associated with therapeutic immunosuppression in patients with multiple sclerosis (MS). So far, more than 600 cases of PML have been reported in association with natalizumab administration. There have also been confirmed cases of PML in individuals who received fingolimod and dimethyl fumarate without previous natalizumab treatment. The new licensed disease-modifying therapies for MS carry the risk of immunosuppressant and so of JCV reactivation. Va...
Source: Drug Safety - November 12, 2016 Category: Drugs & Pharmacology Source Type: research

Proton Pump Inhibitors and Risk of Rhabdomyolysis
AbstractProton pump inhibitors (PPIs) have been associated with a variety of adverse events, although the level of evidence for many of these is weak at best. Recently, one national regulatory authority has mandated a change to the labeling of one PPI based on reports of possible associated rhabdomyolysis. Thus, in this review we summarize the available evidence linking PPI use with rhabdomyolysis. The level of evidence is insufficient to establish a causal relationship and is largely based on sporadic case reports. In general, patients with suspected PPI-associated rhabdomyolysis have not been re-challenged with a PPI aft...
Source: Drug Safety - November 12, 2016 Category: Drugs & Pharmacology Source Type: research

Active Surveillance of Follow-on Biologics: A Prescription for Uptake
AbstractAs lower-cost versions of original biologic drugs made by different manufacturers, follow-on biologics offer the promise of meaningful savings for the US health care system and improved patient health outcomes through greater medication adherence. Fulfillment of this promise, however, is predicated on the prescribing of such products. Under state drug product selection laws, pharmacists may substitute prescriptions for brand name, small-molecule drugs with their generic equivalents, but will be indefinitely prohibited from substituting prescriptions for original biologics with their follow-on biologic counterparts ...
Source: Drug Safety - November 12, 2016 Category: Drugs & Pharmacology Source Type: research

Bone Fractures with Sodium-Glucose Co-transporter-2 Inhibitors: How Real is the Risk?
This article succinctly summarizes the available evidence on the risk of bone fractures with sodium-glucose co-transporter-2 inhibitors. The US Food and Drug Administration has strengthened the warning for canagliflozin related to the increased risk of bone fractures, and added new information about decreased bone mineral density. The agency has also said that it will evaluate the risk of bone fractures with other drugs in the sodium-glucose co-transporter-2 inhibitor class. Increases in parathyroid hormone levels and decreases in 1,25-dihydroxyvitamin D levels have been postulated as possible mechanisms. In contrast, some...
Source: Drug Safety - November 8, 2016 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - November 8, 2016 Category: Drugs & Pharmacology Source Type: research

On Designs for Vaccine Surveillance
(Source: Drug Safety)
Source: Drug Safety - October 26, 2016 Category: Drugs & Pharmacology Source Type: research

Pharmaceutical Benefit –Risk Communication Tools: A Review of the Literature
AbstractThis paper reviews the main tools for communicating benefit –risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also rev iewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit–risk medicines communication is first contextualised within the broader risk communication literature. Three distinct goals are then ma...
Source: Drug Safety - October 14, 2016 Category: Drugs & Pharmacology Source Type: research

Knowledge of Adverse Drug Reaction Reporting Among Healthcare Professionals in Bhutan: A Cross-Sectional Survey
ConclusionClinical doctors and pharmacists have better knowledge of ADRs than nurses and traditional medicine practitioners, while knowledge of ADR reporting was low for all HCPs surveyed. (Source: Drug Safety)
Source: Drug Safety - October 14, 2016 Category: Drugs & Pharmacology Source Type: research

Risk –Benefit Profile of Direct-Acting Oral Anticoagulants in Established Therapeutic Indications: An Overview of Systematic Reviews and Observational Studies
AbstractSince 2008, the direct-acting oral anticoagulants (DOACs) have expanded the therapeutic options of cardiovascular diseases with recognized clinical and epidemiological impact, such as non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE), and also in the preventive setting of orthopedic surgical patients. The large body of evidence, not only from pivotal clinical trials but also from ‘real-world’ postmarketing observational findings (e.g. analytical epidemiological studies and registry data) gathered to date allow for a first attempt at verifying a posteriori whether or not the pharma...
Source: Drug Safety - October 1, 2016 Category: Drugs & Pharmacology Source Type: research

Estimating Herbal Product Authentication and Adulteration in India Using a Vouchered, DNA-Based Biological Reference Material Library
ConclusionsOur findings suggest that most Indian herbal medicinal products are essentially mixed with one or a few other herbs that could lessen the therapeutic activity of the main ingredients. We do not recommend the use of GenBank to identify herbal products because the use of this non-curated and/or vouchered database will result in inaccurate species identification. These DNA-based tools provide a scientific foundation for herbal pharmacovigilance to ensure the safety and efficacy of natural drugs. This study provides curated BRMs that will underpin innovations in molecular diagnostic biotechnology, which will soon pr...
Source: Drug Safety - September 29, 2016 Category: Drugs & Pharmacology Source Type: research

Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study
ConclusionsThe study shows that only one out of eight ADR reports from GPs was ‘well-documented’. Therefore, it appears to be important to promote further information being available regarding the data required in ADR reports to optimise the evaluation of drug causality. (Source: Drug Safety)
Source: Drug Safety - September 29, 2016 Category: Drugs & Pharmacology Source Type: research

The Risk of Achilles or Biceps Tendon Rupture in New Statin Users: A Propensity Score-Matched Sequential Cohort Study
ConclusionThe results of this cohort study suggest that statin use does not increase the risk of tendon rupture, irrespective of gender, age, statin dose, or treatment duration. (Source: Drug Safety)
Source: Drug Safety - September 27, 2016 Category: Drugs & Pharmacology Source Type: research

Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase ®
ConclusionsCluster analysis reveals additional reports of AEs following HPV vaccination that are serious in nature and describe symptoms that overlap those reported in cases from the recent safety signals (POTS, CRPS, and CFS), but which do not report explicit diagnoses. While the causal association between HPV vaccination and these AEs remains uncertain, more extensive analyses of spontaneous reports can better identify the relevant case series for thorough signal evaluation. (Source: Drug Safety)
Source: Drug Safety - September 16, 2016 Category: Drugs & Pharmacology Source Type: research

Prevention of Medication Errors in Hospitalized Patients: The Japan Adverse Drug Events Study
ConclusionsMEs frequently occurred and most at the ordering stage. Almost half of MEs were not intercepted or identified. Many MEs at the later stages were less likely to be intercepted and resulted in actual patient harm. Systems to improve the identification and interception of MEs should be implemented. (Source: Drug Safety)
Source: Drug Safety - September 16, 2016 Category: Drugs & Pharmacology Source Type: research

Role of Preemptive Genotyping in Preventing Serious Adverse Drug Events in South Korean Patients
ConclusionsThis study quantified the number of South Korean patients predicted to have serious ADEs and demonstrated the need for preemptive genotyping to assist safer drug therapy in South Korea. (Source: Drug Safety)
Source: Drug Safety - September 15, 2016 Category: Drugs & Pharmacology Source Type: research

Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients
AbstractIntroductionPatients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case –control study design.MethodThe study was conducted in th...
Source: Drug Safety - September 15, 2016 Category: Drugs & Pharmacology Source Type: research

A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals
DiscussionThe results of this pilot study identify that key factors contributing to the under-reporting of ADEs relate to a lack of standardized process, a lack of training and education, and a lack of integrated health information technologies. (Source: Drug Safety)
Source: Drug Safety - September 15, 2016 Category: Drugs & Pharmacology Source Type: research

16th ISoP Annual Meeting ‘‘Pharmacovigilance for Safer Tomorrow’’ Agra, India 16–19 October, 2016
(Source: Drug Safety)
Source: Drug Safety - September 9, 2016 Category: Drugs & Pharmacology Source Type: research

Vaccine Case –Population: A New Method for Vaccine Safety Surveillance
ConclusionThese results suggest that the vaccine case –population method can produce coherent conclusions and may be used in the future for prospective investigation of urgent vaccine safety concerns or for the prospective generation of vaccine safety signals. This method could also be used to identify selection bias from cases excluded from the case –control study. (Source: Drug Safety)
Source: Drug Safety - September 9, 2016 Category: Drugs & Pharmacology Source Type: research

Patient Reporting of Adverse Drug Reactions: An International Survey of National Competent Authorities ’ Views and Needs
ConclusionsMost countries accept ADR reports from patients by an official reporting system designed for patients or through the existing system for healthcare professionals. The main reasons for not having a PRS is financial restraints and a lack of information/education of patients. Attitudes toward a PRS are positive, but some countries fear that they will not be able to handle an increase in reports. (Source: Drug Safety)
Source: Drug Safety - August 31, 2016 Category: Drugs & Pharmacology Source Type: research

Drug –Drug Interactions, Effectiveness, and Safety of Hormonal Contraceptives in Women Living with HIV
AbstractFamily planning options, including hormonal contraceptives, are essential for improving reproductive health among the more than 17  million women living with HIV worldwide. For these women, prevention of unintended pregnancy decreases maternal and child mortality, as well as reduces the risk of perinatal HIV transmission. Similarly, treatment of HIV with antiretroviral therapy (ART) is essential for reducing morbidity and mort ality among HIV-positive individuals, as well as preventing HIV transmission between sexual partners or from mother to child. Importantly, despite the benefits of hormonal contraceptives...
Source: Drug Safety - August 25, 2016 Category: Drugs & Pharmacology Source Type: research

National ADR Monitoring System in China
AbstractIt has been more than 25  years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstrate h ow individual case safety reports (ICSRs) are reported and evaluated and how data quality control is achieved in China. We also aimed to discuss the present status and future of NADRMS. We reviewed the relevant regulations and literature around ADR reporting in China. ADR report collection t...
Source: Drug Safety - August 22, 2016 Category: Drugs & Pharmacology Source Type: research

Pattern of Onset and Risk Factors for Peripheral Oedema During Vildagliptin Use: Analysis from the Vildagliptin Prescription –Event Monitoring Study in England
This study was a per-protocol supplementary analysis to investigate the pattern of onset and effect of vildagliptin combination therapy on PO risk.MethodsThe PMS used an observational cohort design. OAD exposure, selected risk factors and outcome data were collected from general practitioners in England regarding vildagliptin users for the 6-month period after starting treatment. Data analysis comprised univariate case/non-case analysis, time-to-onset analysis and Cox proportional hazard models to estimate hazard ratios (HR) of PO adjusting for selected patients ’ baseline characteristics.ResultsThe study cohort incl...
Source: Drug Safety - August 17, 2016 Category: Drugs & Pharmacology Source Type: research

Neuropsychiatric Effects of HIV Antiviral Medications
AbstractThe development of antiretroviral therapy (ART) has dramatically increased the lifespan of HIV patients but treatment is complicated by numerous adverse effects and toxicities. ART complications include neuropsychiatric, metabolic, gastrointestinal, cardiac, and numerous other toxicities, and clinicians often have to choose one toxicity over another to offer the best medication regimen for a patient. Some antiviral drugs cause significant neuropsychiatric complications, including depression, cognitive impairment, and sleep disturbance. Even in careful studies, it may be difficult to determine which effects are rela...
Source: Drug Safety - August 17, 2016 Category: Drugs & Pharmacology Source Type: research

Tyrosine Kinase Inhibitor-Induced Interstitial Lung Disease: Clinical Features, Diagnostic Challenges, and Therapeutic Dilemmas
AbstractSince the approval of the first molecularly targeted tyrosine kinase inhibitor (TKI), imatinib, in 2001, TKIs have heralded a new era in the treatment of many cancers. Among their innumerable adverse effects, interstitial lung disease (ILD) is one of the most serious, presenting most frequently with dyspnea, cough, fever, and hypoxemia, and often treated with steroids. Of the 28 currently approved TKIs, 16 (57 %) are reported to induce ILD with varying frequency and/or severity. The interval from drug administration to onset of ILD varies between patients and between TKIs, with no predictable time course. Its incid...
Source: Drug Safety - August 17, 2016 Category: Drugs & Pharmacology Source Type: research

The Patient ’s Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization
AbstractPatient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance syste...
Source: Drug Safety - August 13, 2016 Category: Drugs & Pharmacology Source Type: research

Comment on: “Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence”
(Source: Drug Safety)
Source: Drug Safety - August 8, 2016 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Alain Braillon’s Comment on “Safety and Tolerability of Pharmacological Treatment of Alcohol Dependence: Comprehensive Review of Evidence”
(Source: Drug Safety)
Source: Drug Safety - August 8, 2016 Category: Drugs & Pharmacology Source Type: research

Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns
Abstract Since 1993, how to assess the causality of serious adverse events in premarketing drug clinical trials has undergone sustained regulatory evolution in the USA. In that year, an investigational drug study for chronic hepatitis B virus infection was emergently stopped after a patient suddenly exhibited hepatic failure and lactic acidosis, which later developed, along with pancreatitis and peripheral neuropathy, in several others after drug discontinuation. Five patients eventually died, including three despite emergency liver transplantation. The drug ’s multisystem toxicity was not predicted by preclinical a...
Source: Drug Safety - July 29, 2016 Category: Drugs & Pharmacology Source Type: research

Adverse-Drug-Reaction-Related Hospitalisations in Developed and Developing Countries: A Review of Prevalence and Contributing Factors
Abstract Adverse drug reactions (ADRs) are one of the leading causes of hospital admissions and morbidity in developed countries and represent a substantial burden on healthcare delivery systems. However, there is little data available from low- and middle-income countries. This review compares the prevalence and characteristics of ADR-related hospitalisations in adults in developed and developing countries, including the mortality, severity and preventability associated with these events, commonly implicated drugs and contributing factors. A literature search was conducted via PubMed, Scopus, Web of Science, Embase, ProQ...
Source: Drug Safety - July 23, 2016 Category: Drugs & Pharmacology Source Type: research