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

The Impact of Experiencing Adverse Drug Reactions on the Patient ’s Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands
Conclusion Patients who reported possible ADRs after the Thyrax ® packaging change experienced a significant decrease in HR-QOL. This impact was highest for the domains ‘daily activities’, ‘overall health status’, and ‘mental health’ and lowest for ‘physical fitness’. (Source: Drug Safety)
Source: Drug Safety - July 22, 2016 Category: Drugs & Pharmacology Source Type: research

Hepatic Safety of Atypical Antipsychotics: Current Evidence and Future Directions
Abstract The newer atypical antipsychotic agents (AAPs) represent an attractive therapeutic option for a wide range of psychotic disorders, including schizophrenia and bipolar mania, because of the reduced risk of disabling extrapyramidal symptoms. However, their growing use has raised questions about their tolerability over the endocrine, metabolic, and cardiovascular axes. Indeed, atypical antipsychotic drugs are associated, to differing extents, with mild elevation of aminotransferases related to weight gain, AAP-induced metabolic syndrome, and nonalcoholic fatty liver disease. Although the hepatic safety of new AAPs s...
Source: Drug Safety - July 22, 2016 Category: Drugs & Pharmacology Source Type: research

Drug Interactions of Direct-Acting Oral Anticoagulants
Abstract In recent years, new direct-acting oral anticoagulants (DOACs) have been introduced into clinical practice that specifically inhibit either factor Ia or Xa. These drugs have, to a large extent, replaced warfarin for the treatment of venous thrombosis, pulmonary embolism, and non-valvular atrial fibrillation. They have potential advantages over warfarin in providing more stable anticoagulation and the lack of a need for regular venesection to monitor activity. They also have the promise of less drug and food interactions. All of these drugs are substrates for the permeability glycoprotein (P-gp) excretion ...
Source: Drug Safety - July 19, 2016 Category: Drugs & Pharmacology Source Type: research

Benefit –Risk Assessment of Fish Oil in Preventing Cardiovascular Disease
Abstract Cardiovascular disease (CVD) is a preventable disease, which combines two general processes: chronic vascular inflammation and acute thrombosis. Both are amplified with positive feedback signals by n-6 eicosanoids derived from food-based n-6 highly unsaturated fatty acids (n-6 HUFA). This amplification is lessened by competing actions of n-3 HUFA. Death results from fatal interactions of the vascular wall with platelets and clotting proteins. The benefits of fish oil interventions are confounded by complex details in pharmacokinetics, pharmacodynamics, adverse events, timescale factors, topology, financial incent...
Source: Drug Safety - July 13, 2016 Category: Drugs & Pharmacology Source Type: research

Benefit–Risk Assessment of Fish Oil in Preventing Cardiovascular Disease
Abstract Cardiovascular disease (CVD) is a preventable disease, which combines two general processes: chronic vascular inflammation and acute thrombosis. Both are amplified with positive feedback signals by n-6 eicosanoids derived from food-based n-6 highly unsaturated fatty acids (n-6 HUFA). This amplification is lessened by competing actions of n-3 HUFA. Death results from fatal interactions of the vascular wall with platelets and clotting proteins. The benefits of fish oil interventions are confounded by complex details in pharmacokinetics, pharmacodynamics, adverse events, timescale factors, topology, financia...
Source: Drug Safety - July 13, 2016 Category: Drugs & Pharmacology Source Type: research

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?
Abstract The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide fir...
Source: Drug Safety - July 5, 2016 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics, Efficacy, and Safety of Hepatitis  C Virus Drugs in Patients with Liver and/or Renal Impairment
Abstract Hepatitis C virus (HCV)-infected patients often suffer from liver cirrhosis, which can be complicated by renal impairment. Therefore, in this review we describe the treatment possibilities in HCV patients with hepatic and renal impairment. Cirrhosis alters the structure of the liver, which affects drug-metabolizing enzymes and drug transporters. These modifications influence the plasma concentration of substrates of drugs metabolized/transported by these enzymes. The direct-acting antivirals (DAAs) are substrates of, for example, cytochrome P450 enzymes in the liver. Most DAAs are not studied in HCV-infected indi...
Source: Drug Safety - July 1, 2016 Category: Drugs & Pharmacology Source Type: research

Pacific Island Pharmacovigilance: The Need for a Different Approach
Abstract Many Pacific Island countries (PICs) are recipients of funding support from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). However, most of these countries cannot be expected to meet Global Fund and World Health Organization (WHO) minimum requirements for a functioning pharmacovigilance (PV) system. We argue that a different approach is required to move PV forward in such countries. Although the long-term aim is to build adequate national PV capacity, we propose an approach in which resources are focused initially towards ensuring a proper system for the reporting of “problem...
Source: Drug Safety - June 30, 2016 Category: Drugs & Pharmacology Source Type: research

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study
Conclusion Mobile applications are taking data standards to the point of care, enabling clinicians to ascertain potential adverse events in the ED setting and during inpatient follow-up. Compliance with Clinical Data Interchange Standards Consortium (CDISC) data standards facilitates data interoperability according to regulatory requirements. (Source: Drug Safety)
Source: Drug Safety - June 27, 2016 Category: Drugs & Pharmacology Source Type: research

Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost–Utility Analysis
Conclusion Active surveillance pharmacovigilance was projected to be highly cost effective to improve treatment for HIV in Namibia. Active surveillance pharmacovigilance may be valuable to improve lives of HIV patients and more efficiently allocate health resources in Namibia. (Source: Drug Safety)
Source: Drug Safety - June 17, 2016 Category: Drugs & Pharmacology Source Type: research

Neonatal Adaptation Issues After Maternal Exposure to Prescription Drugs: Withdrawal Syndromes and Residual Pharmacological Effects
Abstract Exposure to drugs during pregnancy has the potential to harm offspring. Teratogenic effects are the most feared adverse outcomes in newborns; however, a wide spectrum of less known, usually reversible and often acute, neonatal adverse events can also occur due to drug intake by mothers during pregnancy, particularly in close proximity to delivery. This narrative review is aimed at the description of drugs and drug classes for which licit maternal use in the predelivery period has been associated with neonatal non-teratogenic disorders. For each drug class, epidemiology, clinical features, biological mecha...
Source: Drug Safety - June 11, 2016 Category: Drugs & Pharmacology Source Type: research

Targeted Spontaneous Reporting: Assessing Opportunities to Conduct Routine Pharmacovigilance for Antiretroviral Treatment on an International Scale
Conclusion We found minimal information is available about facility characteristics that may contribute to pharmacovigilance activities. Our findings, therefore, are a first step that can potentially assist implementers and facility staff to identify opportunities and leverage their existing capacities to incorporate TSR into their routine clinical programs. (Source: Drug Safety)
Source: Drug Safety - June 9, 2016 Category: Drugs & Pharmacology Source Type: research

Pregnancy Outcomes in the Tofacitinib Safety Databases for Rheumatoid Arthritis and Psoriasis
Conclusions The pregnancy outcomes reported in this small number of RA/psoriasis patients appear similar to those observed in the general population and in patients treated with biologic therapies for inflammatory diseases. However, definitive conclusions cannot be drawn, and pregnancy outcomes in patients receiving tofacitinib will continue to be monitored. (Source: Drug Safety)
Source: Drug Safety - June 9, 2016 Category: Drugs & Pharmacology Source Type: research

Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification
Conclusion The performance of the two tested SDAs was similar in the pediatric population. Age adjustment does not improve performance and is therefore not recommended to be performed routinely. Stratification can reveal new associations, and therefore is recommended when either drug use is age-specific or when an age-specific risk is suspected. (Source: Drug Safety)
Source: Drug Safety - June 2, 2016 Category: Drugs & Pharmacology Source Type: research

Artesunate/Amodiaquine-Induced Acute Extrapyramidal Reactions in Children and Younger Adults: Case Series Assessment
Abstract Introduction Several studies conducted in African countries reported the artesunate and amodiaquine (AS/AQ) tablet as a safe and well-tolerated anti-malarial drug in children and younger adults. The aim of this case series assessment was to assess the causal relationship between the AS/AQ tablet and extrapyramidal reactions in children and younger adults and to investigate the factor(s) predisposing to the adverse drug reactions. Methods The causal relationship of all the cases was first assessed individually using the Naranjo Probability Scale ...
Source: Drug Safety - May 20, 2016 Category: Drugs & Pharmacology Source Type: research

Benefit and Risk of Tofacitinib in the Treatment of Rheumatoid Arthritis: A Focus on Herpes Zoster
Abstract The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy to biologics. JAK is activated by multiple cytokines involved in the pathology of RA, and affects non-immune and immune cells, mainly the lymphocytes. Besides its anti-rheumatic effect, the recent focus has been on adverse events. As with other biologics, serious infections have been observe...
Source: Drug Safety - May 18, 2016 Category: Drugs & Pharmacology Source Type: research

Risk of Liver Injury Associated with Green Tea Extract in SLIMQUICK ® Weight Loss Products: Results from the DILIN Prospective Study
Conclusions SLIMQUICK® products can lead to severe acute hepatocellular liver injury, which may result in transplantation. Given the frequency of GTE as a component in weight loss products, this ingredient should be studied further as a possible cause for liver injury. (Source: Drug Safety)
Source: Drug Safety - May 17, 2016 Category: Drugs & Pharmacology Source Type: research

The Impact of Experiencing Adverse Drug Reactions on the Patient’s Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands
The objective of this study was to explore the impact of ADRs on HR-QOL in patients who reported a possible ADR to Lareb in relation to the change in the packaging of the drug Thyrax®. A secondary objective was to explore factors correlated with change in HR-QOL. Methods Patients who reported an ADR in relation to the Thyrax® packaging change were included in this study. A web-based adapted version of the COOP/WONCA questionnaire was sent to explore the HR-QOL before versus during the ADR, expressed on a 5-point scale from no impact (1) to high impact (5). Multivariable linea...
Source: Drug Safety - May 4, 2016 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Liver Injury: Highlights from a Review of the 2015 Literature
Abstract Numerous publications contributed to the expanding knowledge base about drug-induced liver injury (DILI) in 2015. New findings from the US Drug Induced Liver Injury Network (DILIN) in their most recently updated registry include a 1- to 3-week delay in the appearance of acute DILI from short-course antibiotics such as cefazolin. They corroborated the finding that acute DILI in patients with underlying liver disease was far more severe and potentially fatal than in patients without liver disease. The only drug that seemed to have an increased risk of hepatotoxicity in these patients was azithromycin. While...
Source: Drug Safety - May 3, 2016 Category: Drugs & Pharmacology Source Type: research