Anita Conforti

University of Verona | UNIVR · Section of Pharmacology

Introduction Efforts to improve medication access in low-and middle-income countries, particularly in Sub-Saharan Africa, have made progress, especially in the fight against infectious diseases such as tuberculosis. However, challenges exist in establishing effective pharmacovigilance systems. The PhArmacoVIgilance Africa (PAVIA) project was commit...

Objective: We investigated the effects of three different homeopathic medicines in several dilutions/dynamizations on mice, using validated models which explore anxiety-like and emotional symptoms. Two complete series of investigations were performed in order to assess the activity of Gelsemium sempervirens; furthermore, we investigated Ignatia ama...

Aims Statin-related myopathy (SRM), which includes rhabdomyolysis, is an uncommon but important adverse drug reaction because the number of people prescribed statins world-wide is large. Previous association studies of common genetic variants have had limited success in identifying a genetic basis for this adverse drug reaction. We conducted a mult...

Statins can be associated with myopathy. We have undertaken a Genome‐wide Association Study (GWAS) to discover and validate genetic risk‐factors for statin‐induced myopathy in a “real‐world” setting. 135 statin myopathy patients recruited via the UK Clinical Practice Research Datalink were genotyped using the Illumina OmniExpress Exome v1.0 Bead Ch...

PurposeThe use of gastroprotective agents has allowed significant progress in the prevention of upper gastrointestinal bleeding (UGIB) associated with non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents. Nevertheless, some concerns remain regarding the gastroprotective dosage and treatment duration. Our aim was to study the effec...

Background: Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007. Aim: This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. Methods:...

Background & aims: We performed a genome-wide association study (GWAS) to identify genetic risk factors for drug-induced liver injury (DILI) from licensed drugs without previously reported genetic risk factors. Methods: We performed a GWAS of 862 persons with DILI and 10588 population-matched controls. The first set of cases was recruited prior...

Despite the first reports concerning benzodiazepine dependence being published in the early 1960s literature, the risk of benzodiazepine addiction is still greatly debated. The severe discomfort and life threatening complications usually experienced by long-term benzodiazepine users who suddenly interrupt benzodiazepine intake have led to the devel...

Aim: Drug induced liver injury is one of the most serious adverse drug reactions and the most frequent reason of restriction of indications or withdrawal of drugs. Some NSAIDs were withdrawn from the market because of serious hepatotoxicity. We estimated the risk of acute and serious liver injury associated with the use of nimesulide and other NSA...

Angiotensin II receptor blockers (ARBs) are widely used to treat hypertension and heart failure. Photosensitivity reactions are cutaneous adverse events due to exposure to a drug and either ultraviolet or visible radiation. Among the ARB class, this type of adverse drug reaction is labeled only for losartan. The aim of this study was to provide a d...

In the last decades risk culture related to medication errors due to events which are potentially harmful to patients has grown. The aim of this project was to detect the status of implementation of the national Recommendations for the safe and secure handling of drugs in some hospital wards and nursing homes for elderly of Veneto Region. The proje...

Background Risk management is essential for the delivery of safe high-quality social care services. Medicines errors compromise patient confidence in the healthcare system and increase healthcare costs. Purpose The aim of this exploratory analysis was to detect the status of implementation of the national Recommendations for the safe and secure han...

Il "senso del lavoro", come pratica e pensiero, che tiene assieme bisogni, desideri e relazioni, è il filo conduttore del ciclo di incontri seminariali dal quale nasce questo volume. Donne di generazioni diverse affrontano le tante questioni che riguardano il lavoro inteso anche come lavoro di relazione. Ne scaturisce un ampio confronto che ruota a...

Background: Biologicals are important treatment options for various chronic diseases. After the introduction of the first biosimilars, animated debate arose in the scientific community about the actual benefit-risk profile of these drugs. In this context, a comparative safety evaluation of biologicals and biosimilars in clinical practice is warran...

Purpose: The aim of this study was to analyze the cases of gynecomastia associated with α1A-adrenergic receptor antagonists (α1-ARAs) in the Italian spontaneous reporting system database (Rete Nazionale di Farmacovigilanza or RNF) and in the World Health Organization ICSRs database (VigiBase(™)), focusing on tamsulosin use. Methods: We analyzed...

In September 2013 issue of Int. J. Clin. Pract., a lengthy letter concerned “bias and adverse effects in homeopathy”. The letter apparently raised “scientific criticism”, actually was dedicated to throw mud on researchers who deal with homeopathy issues. As group of scientists working in the University of Verona, here we defend the integrity and re...

Several lines of evidence suggest that homeopathic high dilutions (HDs) can effectively have a pharmacological action, and so cannot be considered merely placebos. However, until now there has been no unified explanation for these observations within the dominant paradigm of the dose-response effect. Here the possible scenarios for the physicochemi...

The pharmacodynamics aspects of homeopathic remedies are appraised by laboratory studies on the biological effects at various levels (cellular, molecular and systemic). The major question is how these medicines may work in the body. The possible answers concern the identification of biological targets, the means of drug-receptor interactions, the m...

Aim: To identify prescription drugs involved in falsified prescriptions in community pharmacies in 6 European countries. Methods: A cross-sectional survey among 2,105 community pharmacies in Belgium, France, Italy, the Netherlands, Spain and Sweden was carried out to collect all suspect prescription forms. For each reported drug, the number of r...

Joint evaluation of drugs’ beneficial and adverse effects is required in many situations, in particular to inform decisions on initial or sustained marketing of drugs, or to guide the treatment of individual patients. This synthesis, known as benefit-risk assessment, is without doubt important: timely decisions supported by transparent and sound as...

A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psychotropic drugs. We used spontaneous reports of sus...

Background Adding patients to the range of potential reporters of adverse drug reactions (ADRs) may increase spontaneous reporting and contribute to the detection of signals, one of the primary aims of spontaneous reporting systems. Community pharmacies could have an important role in this context as a service for promoting patient reporting of ADR...

In adults over 65 years of age, the frequency of adverse drug reaction (ADRs) related hospital admissions is higher than in younger adults, and the frequency of ADRs occurring during hospital stay highly ranges. The review was designed to evaluate the frequency of ADRs, both resulting in hospital admission and occurring during the hospital stay of...

The aim of this study was to describe the pattern of adverse drug reaction (ADR) reports sent by Italian nurses after the enactment of the law involving them in the pharmacovigilance system. We also compared the quantity and quality of reports by nurses with those of reports by hospital physicians sent in the same period. We analysed the reports se...

Introduction Ante-partum depression (APD) is usually defined as a non-psychotic depressive episode of mild to moderate severity, beginning in or extending into pregnancy. APD has received less attention than postpartum depression. This is a cross-sectional study carried out in the Obstetrics and Gynaecology (OG) departments of four different genera...

Two previous investigations were performed to assess the activity of Gelsemium sempervirens (Gelsemium s.) in mice, using emotional response models. These two series are pooled and analysed here. Gelsemium s. in various homeopathic centesimal dilutions/dynamizations (4C, 5C, 7C, 9C, and 30C), a placebo (solvent vehicle), and the reference drugs dia...

Riassunto Sono riportati i principali esperimenti svolti nel nostro laboratorio, mediante metodi rigorosi, attendibili e riproducibili, i cui risultati dimostrano che Istamina inibisce l'attivazione dei basofili umani e Gelsemium e Ignatia hanno effetti ansiolitici su modelli murini di comportamento. Tali sostanze agiscono in diluizioni/dinamizzazi...

Ignatia amara (Ignatia), a remedy made from the Strychnos ignatii seeds, is used for anxiety-related symptoms, but consistent evidence of its activity in reproducible experimental models is lacking. An investigation was performed in order to assess on mice, by means of emotional response models, the activity of homeopathic Ignatia dilutions/dynamiz...

As part of a rigorous investigation into the effects of Gelsemium sempervirens on laboratory mice, we performed two complete series of experiments and published three scientific papers. A recent commentary has, however, called into question the reproducibility and validity of these findings. In this article we discuss the major issues raised by thi...

As part of a rigorous investigation into the effects of Gelsemium sempervirens on laboratory mice, we performed two complete series of experiments and published three scientific papers. A recent commentary has, however, called into question the reproducibility and validity of these findings. In this article we discuss the major issues raised by thi...

As a result of a challenging and pioneering work on this medicinal plant, we published three papers that do nothing more than report and discuss the experimental findings, as these were consecutively obtained. These papers contain all the necessary explanations, so that an unbiased perusal of them should be enough to confirm the overall validity of...

The present paper reviews the clinical research carried out over the past three decades to evaluate the effectiveness of homeopathy for the treatment of respiratory allergies, common upper respiratory tract infections, otorhinolaryngologic complaints, and rheumatic diseases. We include in the analysis both randomised and non-randomised trials, assi...

Selective serotonin reuptake inhibitors (SSRIs) have been associated with upper gastrointestinal (GI) bleeding. Given their worldwide use, even small risks account for a large number of cases. This study has been conducted with carefully collected information to further investigate the relationship between SSRIs and upper GI bleeding. We conducted...

Drug-induced liver injury (DILI), especially from antimicrobial agents, is an important cause of serious liver disease. Amoxicillin-clavulanate (AC) is a leading cause of idiosyncratic DILI, but little is understood about genetic susceptibility to this adverse reaction. We performed a genome-wide association study using 822,927 single nucleotide po...

In Italy, as in all of Europe, women differ from men in that they are somewhat more sensitive to the depressogenic effects of stressful life events related to their social networks and emotional sphere. Women are more likely than men to have experienced poverty, gender discrimination, and physical and sexual abuse. The purpose of this study was to...

Gelsemium sempervirens is used in homeopathy for treating patients with anxiety related symptoms, however there have been few experimental studies evaluating its pharmacological activity. We have investigated the effects of homeopathic doses of G. sempervirens on mice, using validated behavioral models. Centesimal (CH) dilutions/dynamizations of G....

Il dato che emerge da questi studi è che la quercetina inibisce l’attivazione allergene-mediata dei basofili a dosi molto basse, sensibilmente inferiori a quelle della letteratura, mentre alle stesse dosi esercita una funzione priming sulla risposta infiammatoria naturale, come può essere quella mediata da un peptide chemiotattico batterico. Non si...

Adverse events (AE) are a relevant problem with major health consequences for both patients and health system in different countries. To estimate and describe the AE and Adverse Drug Reactions (ADRs) detected by nurses in hospital during an observation time of six months. The observational study involved 174 nurses and 36 head nurses. Nurses record...

Flavonoids, a large group of polyphenolic metabolites derived from plants have received a great deal of attention over the last several decades for their properties in inflammation and allergy. Quercetin, the most abundant of plant flavonoids, exerts a modulatory action at nanomolar concentrations on human basophils. As this mechanism needs to be e...

Background: Fluoroquinolones are widely used both in primary care and in hospital settings. Since the last comparison performed in Italy on the safety profiles of different fluoroquinolones, a new molecule, prulifloxacin, has been introduced into the market and several warnings concerning this class of drugs have been released. The aim of this stu...

In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-m...

Background: Drug-drug interactions (DDIs) are an important cause of adverse drug reactions (ADRs). Many studies have recently considered this issue, but most of them focus only on potential interactions and are often related to the hospital setting. A spontaneous reporting database could be a valuable resource for detection of ADRs associated with...

This study was designed to investigate the putative anxiolytic-like activity of ultra-low doses of Gelsemium sempervirens (G. sempervirens), produced according to the homeopathic pharmacopeia. Five different centesimal (C) dilutions of G. sempervirens (4C, 5C, 7C, 9C and 30C), the drug buspirone (5 mg/kg) and solvent vehicle were delivered intraper...

Many different brands of primary care electronic patient record (EPR) software are available to general practitioners (GPs). Their ability to support GPs in improving prescribing varies greatly. To assess, using a ten-item tool, the quality of drug information provided by EPR software to support the appropriateness of prescriptions and to propose a...

The aim of the present study was to collect and compare cases of drug-induced PML in order to contribute to the debate about the role of the underlying diseases and/or drug immunosuppression in PML occurrence. We searched for drug-induced PML cases in two international spontaneous adverse drug reaction (ADR) report databases, FDA-AERS and WHO-VigiB...

Flavonoids, such as quercetin, were reported to inhibit histamine release and cytokine production by basophils, but there is no evidence describing their action on membrane markers and intracellular biochemical pathways. The aim of the study was to examine the effect of several quercetin doses on an in vitro human basophil activation system that ev...

The first part of this paper reviews the effects of homeopathic remedies on several models of anxiety-like behaviours developed and described in rodents. The existing literature in this field comprises some fifteen exploratory studies, often published in non-indexed and non-peer-reviewed journals. Only a few results have been confirmed by multiple...

L’homéopathie est d’abord apparue sous la forme d’une discipline expérimentale, comme le confirme l’énorme quantité de données cliniques réunies sur plus de deux siècles. Cependant, la tradition médicale de l’homéopathie a été séparée de celle de la science conventionnelle pendant longtemps. Aujourd’hui, un processus osmotique entre les disciplines...

Background: Adverse drug reactions (ADRs) represent a major public health concern, with death as the ultimate adverse drug outcome. Despite the relevance of this, the frequency of fatal ADRs (FADRs) is to a large extent unknown. Although spontaneous reporting data cannot give an exact estimate of the magnitude of drug-related mortality, it may high...

To analyze prescriptions in a general-practitioner database over 1 year to determine the frequency, the characteristics, and the monitoring of the severe potential drug-drug interactions (DDIs). We retrospectively analyzed the clinical records from 16 general practitioners in the Veneto region, an area in northern Italy. The study covered the perio...

Background: The reporting of adverse drug reactions (ADRs) is the mainstay of post-marketing surveillance systems. Under-reporting and selective reporting are considered the main limitations of a spontaneous reporting-based pharmacovigilance system. However, excessive reporting induced by external events may also impair signal detection by increas...

Adverse drug reactions (ADRs) represent a major public health concern, with death as the ultimate adverse drug outcome. Despite the relevance of this, the frequency of fatal ADRs (FADRs) is to a large extent unknown. Although spontaneous reporting data cannot give an exact estimate of the magnitude of drug-related mortality, it may highlight the im...

To analyse an Italian database of spontaneous reporting of suspected adverse drug reactions in order to compare the safety profile of amoxicillin and amoxicillin/clavulanic acid. Data were retrieved from the spontaneous reports collected by six Italian regions (the GIF database) from January 1988 to June 2005. Drug utilization data were also availa...

The foundation of homeopathic medicine is the 'Similia Principle', also known as the 'Principle of Similarity' or also as the 'Simile', which reflects the inversion of pharmacological effects in healthy subjects as compared with sick ones. This article describes the inversion of effects, a widespread medical phenomenon, through three possible mecha...

The musculoskeletal system can be a target organ for adverse drug reactions (ADRs). Drug-induced muscle, bone or connective tissue injuries may be due to, i), primary direct drug action, or, ii), undirected consequence of generalized drug-induced disease. Musculoskeletal ADRs may be only temporarily disabling, such as muscle cramps, as well as in o...

One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in...

The clinical studies on the effectiveness of homeopathy in respiratory allergy (18 randomized trials and 9 observational studies) are described. The literature of common immunologic disorders including also upper respiratory tract infections (URTI) and otorhinolaryngology (reported in part 1), is evaluated and discussed. Most of initial evidence-ba...

Background: Signal detection is a crucial element in recognising new adverse drug reactions (ADRs) as soon as possible. HMG-CoA reductase inhibitors (‘statins’), the most potent cholesterol-lowering drugs, are generally well tolerated but can occasionally lead to liver toxicity. Pre- and postmarketing studies on statins revealed an incidence of 0.1...