Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis
ConclusionsInsufficient data exist to quantify or distinguish the risk of acute vs chronic enterocolitis following ipilmumab use. Because of the serious impact of chronic enterocolitis on quality of life and further cancer treatment, future trials evaluating the safety of immunotherapy should report gastrointestinal events in greater detail. (Source: Drug Safety)
Source: Drug Safety - August 4, 2020 Category: Drugs & Pharmacology Source Type: research

Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis
AbstractIntroductionThe European Medicines Agency has suspended the use of ulipristal acetate (UPA) in the treatment of uterine fibroids and is reassessing its association with a risk of liver injury.ObjectivesOur objectives were to characterize the post-marketing reporting of drug-induced liver injury (DILI) with UPA and investigate the underlying pharmacological basis.MethodsWe queried the worldwide FDA Adverse Event Reporting System and performed a disproportionality analysis, selecting only hepatic designated medical events (DMEs) where UPA was reported as suspect. The reporting odds ratios (RORs) were calculated, and ...
Source: Drug Safety - August 3, 2020 Category: Drugs & Pharmacology Source Type: research

Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE
ConclusionReal-world data from EMPIRE showed that patients on anticoagulant medications received nintedanib less frequently, perhaps based on its mechanism of action. Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072). (Source: Drug Safety)
Source: Drug Safety - July 30, 2020 Category: Drugs & Pharmacology Source Type: research

Pharmaceutical Benefit –Risk Perception and Age Differences in the USA and Germany
ConclusionAge has an important role in patients ’ pharmaceutical benefit–risk perceptions. Findings show that, when designing messages, benefit–risk communicators should incorporate age differences. This includes older patients’ positive perceptions of pharmaceuticals, greater reliance on affect, and information seeking versus scanning be haviour. Field experiments are now needed to test the effectiveness of such changes for improving benefit–risk communication practice. (Source: Drug Safety)
Source: Drug Safety - July 23, 2020 Category: Drugs & Pharmacology Source Type: research

Azithromycin in COVID-19 Patients: Pharmacological Mechanism, Clinical Evidence and Prescribing Guidelines
AbstractThe global COVID-19 pandemic has led to a race to find medications that can improve the prognosis of the disease. Azithromycin, in association with hydroxychloroquine or chloroquine, has been proposed as one such medication. The aim of this review is to describe the pharmacological mechanism, clinical evidence and prescribing guidelines concerning azithromycin in COVID-19 patients. There is weak evidence on the antiviral and immunomodulating effects of azithromycin, which in addition is not based on results from COVID-19 patients specifically. Therefore, this antibacterial should be considered only as empirical tre...
Source: Drug Safety - July 21, 2020 Category: Drugs & Pharmacology Source Type: research

A Feasibility Study of Drug –Drug Interaction Signal Detection in Regular Pharmacovigilance
ConclusionThis study shows that signals of adverse drug interactions can be detected through broad statistical screening of individual case reports. It further shows that signal assessment related to possible drug interactions requires more detailed information on the temporal relationship between different drugs and the adverse event. Future research may consider whether interaction signal detection should be performed not for individual adverse event terms but for pairs of drugs across a spectrum of adverse events. (Source: Drug Safety)
Source: Drug Safety - July 17, 2020 Category: Drugs & Pharmacology Source Type: research

Thromboembolism and Janus Kinase Inhibitors
(Source: Drug Safety)
Source: Drug Safety - July 16, 2020 Category: Drugs & Pharmacology Source Type: research

Use of Pregabalin and Worsening Heart Failure: A Nationwide Cohort Study
ConclusionsThe present study found no evidence to support an association between the use of pregabalin and increased risk of worsening heart failure, compared with gabapentin and duloxetine. (Source: Drug Safety)
Source: Drug Safety - July 10, 2020 Category: Drugs & Pharmacology Source Type: research

An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids
ConclusionsWe identified postmarketing cases of serious acute drug-induced liver injury causally associated with ulipristal used to treat uterine fibroids, some with outcomes of liver transplant and/or death. The presence of common structural features identified with certain selective progesterone receptor modulators in the treatment of chronic conditions may indicate a liability for idiosyncratic drug-induced liver injury. (Source: Drug Safety)
Source: Drug Safety - July 9, 2020 Category: Drugs & Pharmacology Source Type: research

Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting
ConclusionsThe high rates of interstitial lung disease reporting derived from mainly the anatomical therapeutic chemical classification group L drugs. Interstitial lung disease is the targeted adverse drug reaction in the use-results survey mandated in the re-examination of those drugs. This system provides at least one explanation for the high reporting of interstitial lung disease in Japan. (Source: Drug Safety)
Source: Drug Safety - July 2, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands
The article “Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands”, written by Linda Härmark, Gerda Weits, Rietje Meijer, Federica Santoro, G. Niklas Norén, Florence van Hunsel, was originally published electronically on 16 May 2020 without open access (Source: Drug Safety)
Source: Drug Safety - July 2, 2020 Category: Drugs & Pharmacology Source Type: research

Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event
AbstractIntroductionChildhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous (same-day) vaccinations, it can be difficult to ascertain which triggered the adverse event. This methods paper discusses a systematic process to determine which of the simultaneously administered vaccine(s) are most likely to have caused an observed increase in risk of an adverse event.MethodsWe use an example from the literature where excess risk of seizure was observed 1  day after vaccination, but same-day vaccination patterns made it difficult t...
Source: Drug Safety - July 1, 2020 Category: Drugs & Pharmacology Source Type: research

Neuroprotective Cationic Arginine-Rich Peptides (CARPs): An Assessment of Their Clinical Safety
AbstractCationic arginine-rich peptides represent a novel class of peptides being developed as neuroprotective agents for stroke and other acute and chronic neurological disorders. As a group, cationic arginine-rich peptides have a diverse range of other biological properties including the ability to traverse cell membranes, modulate immune responses, antagonise ion channel receptor function, as well as possessing cardioprotective, anti-nociceptive, anti-microbial and anti-cancer properties. A sound understanding of their safety profile is essential for the design of future clinical trials and for ensuring translational su...
Source: Drug Safety - July 1, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Safety Communication Tools and Healthcare Professionals ’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study
In the original publication of the article, the headings of columns 3 and 4 in the data table. (Source: Drug Safety)
Source: Drug Safety - June 30, 2020 Category: Drugs & Pharmacology Source Type: research

Safety Profile of Ceftazidime –Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme
ConclusionThe observed safety profile of ceftazidime –avibactam across infection types is consistent with the established safety profile of ceftazidime monotherapy and no new safety findings were identified. This analysis supports the use of ceftazidime–avibactam as a treatment option in adults with cUTI, cIAI and NP, including VAP. (Source: Drug Safety)
Source: Drug Safety - June 29, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of a Web-Based, ‘Purchase Event’ Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand
ConclusionsThese web-based, purchase event, intensive monitoring studies, with cohorts built through NHP purchases in pharmacies, identified substantial issues with recruiting pharmacists/pharmacies and NHP purchasers that, at present, render such studies unfeasible. Future studies need to consider other methods of recruiting NHP purchasers and develop a simple method for recording NHP purchases. (Source: Drug Safety)
Source: Drug Safety - June 28, 2020 Category: Drugs & Pharmacology Source Type: research

Onapristone Extended Release: Safety Evaluation from Phase I –II Studies with an Emphasis on Hepatotoxicity
AbstractIntroductionAntiprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progesterone receptor antagonist originally developed as an oral contraceptive and later evaluated in phase II studies for metastatic breast cancer. Because of liver enzyme elevations identified during clinical studies, further development was halted. Evaluation of antiprogestin pharmacology and pharmacokinetic data suggested that liver enzyme elevations might be related to off-target or metabolic effects ...
Source: Drug Safety - June 27, 2020 Category: Drugs & Pharmacology Source Type: research

Correction to: Comparing Acute Kidney Injury Reports Among Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)
In the original publication of the article, the second sentence in the figure  2 caption should read as below: (Source: Drug Safety)
Source: Drug Safety - June 26, 2020 Category: Drugs & Pharmacology Source Type: research

Detecting Medicine Safety Signals Using Prescription Sequence Symmetry Analysis of a National Prescribing Data Set
ConclusionPSSA was able to identify potential signals for further evaluation. With the increasing availability of different administrative health data sources, the strengths and weaknesses of methods used to analyse these data for the purpose of regulatory PV should be evaluated. (Source: Drug Safety)
Source: Drug Safety - June 23, 2020 Category: Drugs & Pharmacology Source Type: research

Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment
ConclusionsBased on currently available data, there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19. Risk data suggested a possible decrease in serious adverse events. There was a reduction in acute respiratory distress syndrome with lopinavir-ritonavir in one study. Overall, the benefit-risk profile for lopinavir-ritonavir in severe COVID-19 cannot be considered positive until further efficacy and effectiveness data become available. (Source: Drug Safety)
Source: Drug Safety - June 23, 2020 Category: Drugs & Pharmacology Source Type: research

The Impact of the COVID-19 “Infodemic” on Drug-Utilization Behaviors: Implications for Pharmacovigilance
AbstractThe coronavirus disease 2019 (COVID-19) pandemic that hit the world in 2020 triggered a massive dissemination of information (an “infodemic”) about the disease that was channeled through the print, broadcast, web, and social media. This infodemic also included sensational and distorted information about drugs that likely first influenced opinion leaders and people particularly active on social media and then other people, thus affecting choices by individual patients everywhere. In particular, information has spread about some drugs approved for other indications (chloroquine, hydroxychloroquine, nonste...
Source: Drug Safety - June 22, 2020 Category: Drugs & Pharmacology Source Type: research

Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase
ConclusionsThis study reveals that it is possible to uncover signals of risk groups for adverse drug reactions through incorporation of broad risk factor screening into statistical signal detection in a global database of adverse event reports. Our findings suggest the potential to use such statistical methodologies for risk characterisation in subpopulations of concern. (Source: Drug Safety)
Source: Drug Safety - June 20, 2020 Category: Drugs & Pharmacology Source Type: research

Comparative Outcomes Between Direct Oral Anticoagulants, Warfarin, and Antiplatelet Monotherapy Among Chinese Patients with Atrial Fibrillation: A Population-Based Cohort Study
ConclusionAntiplatelet prescribing and suboptimal warfarin management remain common in Chinese patients with AF at high risk of stroke. DOAC use may be associated with a lower risk of ischemic stroke and all-cause mortality when compared with antiplatelets and with a lower risk of ICH when compared with warfarin. (Source: Drug Safety)
Source: Drug Safety - June 18, 2020 Category: Drugs & Pharmacology Source Type: research

Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study
ConclusionNo association was identified between intravitreal aflibercept and non-ocular haemorrhage versus ranibizumab. A comparable risk for these intravitreal anti-VEGFs and intravitreal dexamethasone was observed. (Source: Drug Safety)
Source: Drug Safety - June 16, 2020 Category: Drugs & Pharmacology Source Type: research

Use of Social Media for Pharmacovigilance Activities: Key Findings and Recommendations from the Vigi4Med Project
The objective of this paper is to present the main findings and subsequent recommendations from the French research project Vigi4Med, which evaluated the use of social media, mainly web forums, for pharmacovigilance activities. This project included an analysis of the existing literature, which contributed to the recommendations presented herein. The recommendations are categorized into three categories: ethical (related to privacy, confidentiality, and follow-up), qualitative (related to the quality of the information), and quantitative (related to statistical analysis). We argue that the progress in information technolog...
Source: Drug Safety - June 16, 2020 Category: Drugs & Pharmacology Source Type: research

The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England
ConclusionPositively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status. (Source: Drug Safety)
Source: Drug Safety - June 16, 2020 Category: Drugs & Pharmacology Source Type: research

Thromboembolic Safety Reporting of Tofacitinib and Baricitinib: An Analysis of the WHO VigiBase
ConclusionThis study supports the current recommendation for cautious use of tofacitinib in patients with high thromboembolic risk. Moreover, with a similar patient profile and elevated reporting for baricitinib, a potential class effect of JAK inhibitors cannot be ruled out. (Source: Drug Safety)
Source: Drug Safety - June 12, 2020 Category: Drugs & Pharmacology Source Type: research

Does Ibuprofen Worsen COVID-19?
(Source: Drug Safety)
Source: Drug Safety - June 11, 2020 Category: Drugs & Pharmacology Source Type: research

Drug-Induced Liver Injury and COVID-19 Infection: The Rules Remain the Same
(Source: Drug Safety)
Source: Drug Safety - June 8, 2020 Category: Drugs & Pharmacology Source Type: research

Drug Safety in Geriatric Patients: Current Status and Proposed Way Forward
We present some proposals to overcome the barriers preventing the enrollment of frail elderly patients in clinical trials, and strategies for monitoring their therapy to minimize the risk of adverse reactions. Automated a lerts for drug and drug–disease interactions could help appropriate prescribing but should flag only clinically relevant interactions. Pharmaceutical forms should be designed to allow easy dose adjustment and, together with packaging and labeling, should account for the physical and cognitive limi tations of frail elderly patients. Aggregate pharmacovigilance reports should summarize the safety prof...
Source: Drug Safety - June 4, 2020 Category: Drugs & Pharmacology Source Type: research

Channeling Bias in the Analysis of Risk of Myocardial Infarction, Stroke, Gastrointestinal Bleeding, and Acute Renal Failure with the Use of Paracetamol Compared with Ibuprofen
ConclusionsFor paracetamol versus ibuprofen, when using LSPS methods in the CPRD, it is only possible to distinguish true effects if those effects are large (hazard ratio  >  2). Due to their smaller hazard ratios, the outcomes under study cannot be differentiated from null effects (represented by negative controls) even if there were a true effect. Based on these data, we conclude that we are unable to determine whether paracetamol is associated with an increased ris k of myocardial infarction, stroke, GI bleeding, and acute renal failure compared to ibuprofen, due to residual confounding. (Source: Drug Safety)
Source: Drug Safety - June 4, 2020 Category: Drugs & Pharmacology Source Type: research

A New Drug –Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study
ConclusionOur study identified a signal for the association hydroxychloroquine  + metformin that appears to be more at risk of fatal outcomes (particularly by completed suicides) than one of the two drugs when given alone. (Source: Drug Safety)
Source: Drug Safety - June 3, 2020 Category: Drugs & Pharmacology Source Type: research

Remdesivir in Treatment of COVID-19: A Systematic Benefit –Risk Assessment
ConclusionsPreliminary clinical trial results suggest that there may be a favourable benefit –risk profile for remdesivir compared with placebo in severe COVID-19 infection and further data on benefits would strengthen this evaluation. There is limited safety data for remdesivir, which should be obtained in further studies. The current framework summarises the key anticipated benefits and risks for which further data are needed. Ongoing clinical trial data can be incorporated into the framework when available to provide an updated benefit–risk assessment. (Source: Drug Safety)
Source: Drug Safety - May 28, 2020 Category: Drugs & Pharmacology Source Type: research

Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases
ConclusionsThe patient perspective gives important insights into the burden of ADRs experienced with biologics. This information could be used by healthcare professionals to optimise treatment with biologics. (Source: Drug Safety)
Source: Drug Safety - May 25, 2020 Category: Drugs & Pharmacology Source Type: research

Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety
ConclusionsWhile limited by the small number of pregnancies and related data from the cladribine clinical development program, highlighting the need for further study, the observations made in the present analysis were generally consistent with epidemiological data on pregnancy outcomes for the general population or women with multiple sclerosis. There were no congenital malformations in pregnancies that occurred during cladribine treatment or within 6  months after the last dose. As the data available for cladribine-exposed pregnancies in patients with multiple sclerosis are limited, a non-interventional post-authori...
Source: Drug Safety - May 23, 2020 Category: Drugs & Pharmacology Source Type: research

Information Visualization Platform for Postmarket Surveillance Decision Support
ConclusionsThe InfoViP system uses context-driven interactive visualizations and informatics tools to assist FDA SEs in synthesizing data from multiple sources for their case series analyses. (Source: Drug Safety)
Source: Drug Safety - May 22, 2020 Category: Drugs & Pharmacology Source Type: research

A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data
AbstractSeveral approaches have been proposed recently to accelerate the pathway from drug discovery to patient access. These include novel designs such as using controls external to the clinical trial where standard randomised controls are not feasible. In parallel, there has been rapid growth in the application of routinely collected healthcare ‘real-world’ data for post-market safety and effectiveness studies. Thus, using real-world data to establish an external comparator arm in clinical trials is a natural next step. Regulatory authorities have begun to endorse the use of external comparators in certain ci...
Source: Drug Safety - May 21, 2020 Category: Drugs & Pharmacology Source Type: research

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands
ConclusionPatient organizations can help enable effective communication of adverse drug reactions to a relevant audience. The social media post generated more engagement than other communications from the patient organization, indicating a strong interest in this information. The additional patient experiences that were shared in the comments on social media further strengthened the original signal and its relevance to patients, creating an interesting feedback loop. The favourable experiences in this study support further consideration and exploration of this approach to communicate adverse drug reactions to patients. (Source: Drug Safety)
Source: Drug Safety - May 16, 2020 Category: Drugs & Pharmacology Source Type: research

Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project
ConclusionWe warn the community about a potentially large discrepancy between the expected performance of automated AE recognition systems based on published results and the actual observed performance on independent data. This study highlights the difficulty of implementing an all-purpose system for automatic adverse event recognition in Twitter, which could explain the lack of such systems in practical pharmacovigilance settings. Our recommendation is to use benchmark independent datasets, such as the WEB-RADR reference, to investigate the transferability of the adverse event recognition systems and ultimately enforce ri...
Source: Drug Safety - May 14, 2020 Category: Drugs & Pharmacology Source Type: research

Pathophysiology of Drug-Induced Hypomagnesaemia
AbstractMagnesium (Mg2+) is the second most abundant intracellular and fourth extracellular cation found in the body and is involved in a wide range of functions in the human cell and human physiology. Its role in most of the enzyme processes (ATP-ases) —stabilisation of nucleic acids (DNA, RNA), regulation of calcium and potassium ion channels, proliferation, glucose metabolism and apoptosis—make it one of the most important cations in the cell. Three pathogenetic mechanisms are mainly implicated in the development of hypomagnesaemia: reduced food intake, decreased intestinal absorption and increased renal exc...
Source: Drug Safety - May 12, 2020 Category: Drugs & Pharmacology Source Type: research

Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions
ConclusionThe accuracy of signal detection using social media can be improved by combining signals with those from SRSs. However, the combined system cannot achieve better AUC performance than data from FAERS alone, which may indicate that Twitter data are not ready to be integrated into a purely data-driven combination system. (Source: Drug Safety)
Source: Drug Safety - May 8, 2020 Category: Drugs & Pharmacology Source Type: research

The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic
(Source: Drug Safety)
Source: Drug Safety - May 7, 2020 Category: Drugs & Pharmacology Source Type: research

Critical Assessment of Pharmacokinetic Drug –Drug Interaction Potential of Tofacitinib, Baricitinib and Upadacitinib, the Three Approved Janus Kinase Inhibitors for Rheumatoid Arthritis Treatment
AbstractThe introduction of novel, small-molecule Janus kinase inhibitors namely tofacitinib, baricitinib and upadacitinib has provided an alternative treatment option for patients with rheumatoid arthritis outside of traditional drugs and expensive biologics. This review aimed to critically assess the drug –drug interaction potential of tofacitinib, baricitinib and upadacitinib and provide a balanced perspective for choosing the most appropriate Janus kinase inhibitor based on the needs of patients with rheumatoid arthritis including co-medications and renal/hepatic impairment status. Based on the c ritical assessme...
Source: Drug Safety - May 4, 2020 Category: Drugs & Pharmacology Source Type: research

Effect of Bempedoic Acid on Serum Uric Acid and Related Outcomes: A Systematic Review and Meta-analysis of the available Phase 2 and Phase 3 Clinical Studies
AbstractIntroductionBempedoic acid (ETC-1002) is a first-in-class lipid-lowering agent recently approved by the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for commercialization.ObjectiveThe aim was to assess, through a systematic review of the literature and a meta-analysis of the available phase 2 and phase 3 clinical studies, the effect of treatment with bempedoic acid on serum uric acid (SUA) concentration. Secondary outcomes were treatment-related variations in creatinine serum level and incidence of gout.MethodsA systematic literature search in SCOPUS, PubMed Medline,...
Source: Drug Safety - May 1, 2020 Category: Drugs & Pharmacology Source Type: research

Oxycodone, Hydromorphone, and the Risk of Suicide: A Retrospective Population-Based Case –Control Study
ConclusionsWhile preliminary, these findings support the possibility that some high-potency opioids might independently influence the risk of suicide in susceptible individuals. (Source: Drug Safety)
Source: Drug Safety - April 23, 2020 Category: Drugs & Pharmacology Source Type: research

The International Society of Pharmacovigilance (ISoP) Special Interest Group on Herbal and Traditional Medicines: Towards Progress in Pharmacovigilance for Herbal and Traditional Medicines and Other “Natural Health” Products
(Source: Drug Safety)
Source: Drug Safety - April 23, 2020 Category: Drugs & Pharmacology Source Type: research

DPP-4 Inhibitors in Combination with Lipid-Lowering Agents and Risk of Serious Muscular Injury: A Nested Case-Control Study in a Nationwide Cohort of Patients with Type 2 Diabetes Mellitus
ConclusionIn this study, DPP-4 inhibitor use was not associated with an increased risk of serious muscular injury among patients with type 2 diabetes mellitus using statins or fibrates. (Source: Drug Safety)
Source: Drug Safety - April 18, 2020 Category: Drugs & Pharmacology Source Type: research

Should Patients Receiving ACE Inhibitors or Angiotensin Receptor Blockers be Switched to Other Antihypertensive Drugs to Prevent or Improve Prognosis of Novel Coronavirus Disease 2019 (COVID-19)?
(Source: Drug Safety)
Source: Drug Safety - April 17, 2020 Category: Drugs & Pharmacology Source Type: research

Erice Call for Change: Utilising Patient Experiences to Enhance the Quality and Safety of Healthcare
AbstractThis ‘Erice Call for Change’ is a report from a group of experts, patients and patient representatives who met in Erice in September 2019 following previous similar meetings after the original Erice Declaration (1996). The aim of the meeting was to discuss the challenge of causal complexity and indiv idual variation in modern healthcare. The group’s concern was the impact that new clinical decision-making tools, based on statistical correlations in large databases, could have on individual patient care if they replace other types of clinical investigation and knowledge. The group calls for a c han...
Source: Drug Safety - April 15, 2020 Category: Drugs & Pharmacology Source Type: research

Evidence of Clinically Meaningful Drug –Drug Interaction With Concomitant Use of Colchicine and Clarithromycin
ConclusionClinical manifestations of colchicine –clarithromycin interaction may resemble other systemic diseases and may be life threatening. Understanding this clinically meaningful interaction can help clinicians avoid unsafe medication combinations. (Source: Drug Safety)
Source: Drug Safety - April 9, 2020 Category: Drugs & Pharmacology Source Type: research