Safety Profile of Biological Medicines as Compared with Non-Biologicals: An Analysis of the Italian Spontaneous Reporting System Database
Conclusions Most ADRs attributed to biologicals are ‘skin and subcutaneous tissue disorders’. Anticancer monoclonal antibodies are most frequently associated with ADRs. A low proportion of ADR reports concern biosimilars. (Source: Drug Safety)
Source: Drug Safety - September 26, 2014 Category: Drugs & Pharmacology Source Type: research

Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)
Conclusions Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts. (Source: Drug Safety)
Source: Drug Safety - September 26, 2014 Category: Drugs & Pharmacology Source Type: research

Relevance of Foreign Alerts and Newsletters for the Medication Errors Reporting Programme in The Netherlands: An Explorative Retrospective Study
Conclusion This study showed for a broad range of errors that the Dutch national reporting programme could learn from the three reporting programmes in Canada, the US and the UK. National reporting programmes can benefit from sharing alerts and newsletters that enhance the learning between countries. (Source: Drug Safety)
Source: Drug Safety - September 26, 2014 Category: Drugs & Pharmacology Source Type: research

Pharmacotherapy of Type 2 Diabetes Mellitus: An Update on Drug–Drug Interactions
Abstract The incidence of type 2 diabetes mellitus is increasing rapidly, as are the associated co-morbidities. Consequently, it has become necessary for a diabetic patient to take multiple medications at the same time to delay progression of the disease. This can put patients at an increased risk of moderate to severe drug interactions, which may threaten patients’ life or may deteriorate the quality of their life. Hence, managing drug–drug interactions is the cornerstone of anti-diabetic therapy. Most of the clinically important drug–drug interactions of anti-diabetic agents are related to thei...
Source: Drug Safety - September 24, 2014 Category: Drugs & Pharmacology Source Type: research

Comment on: Prescribing of Rosiglitazone and Pioglitazone Following Safety Signals Analysis of Trends in Dispensing Patterns in The Netherlands from 1998 to 2008
(Source: Drug Safety)
Source: Drug Safety - September 24, 2014 Category: Drugs & Pharmacology Source Type: research

Author’s Reply to Carracedo-Martínez E Comment on: “Prescribing of Rosiglitazone and Pioglitazone Following Safety Signals: Analysis of Trends in Dispensing Patterns in The Netherlands from 1998 to 2008”
(Source: Drug Safety)
Source: Drug Safety - September 24, 2014 Category: Drugs & Pharmacology Source Type: research

Pharmacovigilance in China: Current Situation, Successes and Challenges
Abstract With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centre...
Source: Drug Safety - September 14, 2014 Category: Drugs & Pharmacology Source Type: research

Fidelity Assessment of a Clinical Practice Research Datalink Conversion to the OMOP Common Data Model
Conclusion CPRD can be accurately transformed into the OMOP CDM with acceptable information loss across drugs, conditions and observations. We determined that for a particular use, case CDM structure was adequate and mappings could be improved but did not substantially change the results of our analysis. (Source: Drug Safety)
Source: Drug Safety - September 4, 2014 Category: Drugs & Pharmacology Source Type: research

Converting to a Common Data Model: What is Lost in Translation?
(Source: Drug Safety)
Source: Drug Safety - September 4, 2014 Category: Drugs & Pharmacology Source Type: research

Restrictive Reimbursement Policies: Bias Implications for Claims-Based Drug Safety Studies
Abstract Restrictive reimbursement policies—including those based on non-formulary drug status and prior authorizations—can create situations in which patients’ use of prescription medications is not fully captured in administrative claims data. This can create bias in drug safety studies that depend solely on these data. An analysis in two Canadian provinces found that primary administrative databases captured only 61 % of dispensations of drugs for which restrictive reimbursement policies were in place. A subsequent simulation study found that, in certain circumstances bias due to exposure...
Source: Drug Safety - September 4, 2014 Category: Drugs & Pharmacology Source Type: research

Dosage Effects of Histamine-2 Receptor Antagonist on the Primary Prophylaxis of Non-Steroidal Anti-Inflammatory Drug (NSAID)-Associated Peptic Ulcers: A Retrospective Cohort Study
Conclusion High-dose H2RA showed greater effectiveness than low-dose H2RA in the primary prophylaxis of NSAID-associated PUs in short-term new users. (Source: Drug Safety)
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Cardiovascular Effects of Methylphenidate, Amphetamines and Atomoxetine in the Treatment of Attention-Deficit Hyperactivity Disorder: An Update
Abstract Several million children and a growing number of adults are currently being treated for attention-deficit hyperactivity disorder (ADHD) worldwide. Concerns have been expressed about possible cardiac effects of the common treatments, namely methylphenidate, amphetamines and atomoxetine. Small increases in mean heart rate (HR) and mean blood pressure (BP) have been reported for all three drugs, but most of the studies have not yielded statistically significant results. These studies also have limitations, particularly regarding the lack of accepted and standardised measurement methods. Several large studie...
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Tolerability and Safety of the New Anti-Obesity Medications
Abstract Worldwide obesity prevalence has nearly doubled since 1980. Due to numerous co-morbidities, obesity represents a serious health and socioeconomic problem worldwide. Pharmacotherapy should be an integral part of comprehensive obesity management. Drug therapy can assist in weight loss and its maintenance in those individuals who do not achieve appropriate weight loss through lifestyle interventions alone. After the withdrawal of sibutramine from the market in 2010, orlistat, a lipase inhibitor, was the only remaining prescription drug approved for the long-term treatment of obesity. In 2012, phentermine/to...
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Adverse Gastrointestinal Events with Intravitreal Injection of Vascular Endothelial Growth Factor Inhibitors: Nested Case–Control Study
Conclusions In this population-based study, intravitreal injections of bevacizumab and ranibizumab were not associated with increased risks of adverse GI events. (Source: Drug Safety)
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Hyperkalemia
Abstract Hyperkalemia is a common clinical condition that can be defined as a serum potassium concentration exceeding 5.0 mmol/L. Drug-induced hyperkalemia is the most important cause of increased potassium levels in everyday clinical practice. Drug-induced hyperkalemia may be asymptomatic. However, it may be dramatic and life threatening, posing diagnostic and management problems. A wide range of drugs can cause hyperkalemia by a variety of mechanisms. Drugs can interfere with potassium homoeostasis either by promoting transcellular potassium shift or by impairing renal potassium excretion. Drugs may also i...
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance
Abstract Pharmacovigilance seeks to detect and describe adverse drug reactions early. Ideally, we would like to see objective evidence that a chosen signal detection approach can be expected to be effective. The development and evaluation of evidence-based methods require benchmarks for signal detection performance, and recent years have seen unprecedented efforts to build such reference sets. Here, we argue that evaluation should be made against emerging and not established adverse drug reactions, and we present real-world examples that illustrate the relevance of this to pharmacovigilance methods development fo...
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Association Between Statin Use and Bell’s Palsy: A Population-Based Study
This study aimed to evaluate the association between statin use and Bell’s palsy using a population-based health insurance database. Methods This case-control study identified 1,977 subjects with Bell’s palsy as cases and 5,931 sex- and age-matched subjects without Bell’s palsy as controls from the Taiwan Longitudinal Health Insurance Database 2000. Conditional logistic regressions was used to estimate the odds ratio (OR) and 95 % confidence interval (CI) for previous use of statins between the cases and controls. The associations of regular and irregular s...
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

Adverse Reactions to Contrast Media: An Analysis of Spontaneous Reports in the Database of the Pharmacovigilance Programme of India
Conclusions Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media. (Source: Drug Safety)
Source: Drug Safety - September 1, 2014 Category: Drugs & Pharmacology Source Type: research

The Authors' Reply
(Source: Drug Safety)
Source: Drug Safety - October 13, 2013 Category: Drugs & Pharmacology Authors: Toovey, Stephen Tags: Correspondence Source Type: research

Global Patterns of Adverse Drug Reactions Over a Decade: Analyses of Spontaneous Reports to VigiBase™
(Source: Drug Safety)
Source: Drug Safety - October 13, 2013 Category: Drugs & Pharmacology Authors: Aagaard, LiseStrandell, JohannaMelskens, LarsPetersen, Paw S.G.>Ebba Holme Hansen Tags: Original Research Articles Source Type: research