A5103097811- Pharmacovigilance and Adverse Drug Reactions
- Drug-Induced Adverse Reactions
- Pharmaceutical Economics and Policy
- Pharmaceutical studies and practices
- Inflammatory mediators and NSAID effects
- Health Systems, Economic Evaluations, Quality of Life
- Antibiotic Use and Resistance
- Biosimilars and Bioanalytical Methods
- Antibiotics Pharmacokinetics and Efficacy
- Lipoproteins and Cardiovascular Health
- Atrial Fibrillation Management and Outcomes
- Drug-Induced Hepatotoxicity and Protection
- Pharmacogenetics and Drug Metabolism
- Statistical Methods in Clinical Trials
- Computational Drug Discovery Methods
- Vaccine Coverage and Hesitancy
- Antimicrobial Resistance in Staphylococcus
- Biomedical Ethics and Regulation
- SARS-CoV-2 and COVID-19 Research
- Gastroesophageal reflux and treatments
- Medication Adherence and Compliance
- Pharmaceutical Practices and Patient Outcomes
- Cardiac electrophysiology and arrhythmias
- Urinary Tract Infections Management
- Asthma and respiratory diseases
University of Bologna
2016-2025
Weatherford College
2013
GNA University
2012
University of Verona
2012
Agenzia Regionale Prevenzione e Ambiente della Regione Emilia-Romagna
2012
Italian Medicines Agency
2006
To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.Case/noncase reports associated with antidiabetic drug were retrieved from U.S. Food Drug Administration (FDA) Adverse Event Reporting System (AERS) 2004 2009 analyzed by odds ratio (ROR).Ninety-three of retrieved, corresponding to 138 drug-reaction pairs (pioglitazone, 31; insulin, 29; metformin, 25; glimepiride, 13; exenatide, 8; others, 22). ROR was...
To analyse an Italian database of spontaneous reporting suspected adverse drug reactions in order to compare the safety profile amoxicillin and amoxicillin/clavulanic acid. Data were retrieved from reports collected by six regions (the GIF database) January 1988 June 2005. Drug utilization data also available for two drugs. The comparison between acid was made using χ2 or Student's t-test, when appropriate. Disproportionality events assessed odds ratio methodology. Up 2005, 37 906 reports,...
Drug-induced liver injury is one of the most serious adverse drug reactions and frequent reason for restriction indications or withdrawal drugs. Some nonsteroidal anti-inflammatory drugs (NSAIDs) were withdrawn from market because hepatotoxicity. We estimated risk acute associated with use nimesulide other NSAIDs, a prevalence greater than equal to 5%.This multicentre case-control study carried out in nine Italian hospitals October 2010 January 2014. Cases adults, diagnosis injury. Controls...
Since the first COVID-19 messenger RNA vaccines became available globally for emergency or conditional use, post-marketing surveillance activities have been implemented monitoring of any adverse events that might arise in daily clinical practice and were not detected earlier during trials.Safety data concerning BNT162b2 mRNA-1273 collected from Vaccine Adverse Event Reporting System (VAERS) period December 2020 to October 15, 2021. In addition a descriptive analysis individuals who...
Background: The advent of biosimilars has revolutionized the management conditions like rheumatoid arthritis by offering cost-effective alternatives to expensive biologics. Objectives: This study aims compare post-marketing safety profiles used in rheumatology with their respective reference products (RPs). Methods: Data were retrieved from EudraVigilance for adalimumab, etanercept, infliximab, and rituximab, compared RPs. Our analysis focused on authorized before 2021, using data January...
What is already known about this subject We recently proposed an algorithm to assess the degree of therapeutic innovation new agents. It was based on disease seriousness, availability previous treatments and extent effect, applied all agents approved by EMEA in period 1995–2003. A low percentage (32%) important found. This figure may be underestimate actual level innovation, because common biotechnological products, such as recombinant human insulins, must follow centralized procedure. study...
Direct oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered aspects remain be addressed available evidence on the risk associated with these drugs are conflicting. In order contribute debate their profile, we conducted comparative analysis of reports suspected adverse drug reactions (ADRs) DOACs VigiBase.
Since vaccination against COVID-19 is recommended in pregnant people, we aimed to provide further evidence on the safety profile of vaccines pregnancy.Data adverse events following immunizations (AEFIs) people were retrieved from open-access Vaccine Adverse Event Reporting System (VAERS) December 2020 April 2022.From 1, 2022, a total 4,869 reports involving women at reported VAERS. Among recipients, most belonged age group between 30 and 39 years old (3,029; 62.21%) nearly half experienced...
Since January 1995, all European Union applications for marketing approval medicinal products derived from biotechnology and other drugs considered potentially innovative follow the EMEA centralized procedure. In order to assess overall degree of therapeutic innovation these drugs, we considered, each approved agent, its target, availability previous treatments extent effect. The following scores were assigned through a consensus process: ‘A’ (important), ‘B’ (moderate) ‘C’ (modest)....
Purpose H1-antihistamines are commonly used in infants and children for the relief of histamine-mediated symptoms a variety conditions. Little is known about their safety profile these patients. We performed comparative analysis profiles using data from WHO database (VigiBase). Methods selected adverse drug reaction (ADR) reports on (0–16 years) up to June 2014 VigiBase. ADRs were codified according MedDRA terminology. The reporting odds ratios (RORs) with 95% confidence drug-reaction pairs...
Aims Human papilloma virus (HPV) is the cause of different types carcinoma. Despite remarkable effectiveness HPV vaccines, there have been many complaints about their risk–benefit profile due to adverse events following immunization (AEFI). The purpose this study analyse safety vaccine basing on real‐life data derived from reports suspected AEFIs collected in US Vaccine Adverse Events Reporting System (VAERS) and assess if searches Google overlap with spontaneous reporting. Methods We all...
Objectives To evaluate antibiotic consumption in the pediatric wards of Emilia-Romagna Region, from 2004 to 2011, with a focus on antibiotics reserved most serious infections, and analyse ADRs reported for by hospitals. Methods Reference population was represented all patients (0–14 years old) admitted hospitals Region. Drug expressed as number DDDs per 100 Bed-Days (BD) data were analysed active substance, therapeutic subgroups or ward type. The time trends statistically linear regression....
Concerns have been raised about the actual benefit and safety of molnupiravir, a new antiviral treatment for coronavirus disease 2019 (COVID-19). In order to provide additional evidence support its use, we aimed evaluate real profile based on post-marketing pharmacovigilance data. Molnupiravir data were captured from FDA Adverse Event Reporting System (FAERS). We performed descriptive analysis baseline demographic characteristics patients who experienced at least one adverse drug reaction...