Search results for "pharmacovigilance"

Vaccination in multiple sclerosis patients treated with highly effective disease-modifying drugs: an overview with consideration of cladribine tablets

2021

Infectious diseases are an important consideration in autoimmune conditions such as multiple sclerosis. Infective episodes may trigger relapses and significantly deteriorate the course of the disease. Some immunotherapies may cause increased rates of infection-related adverse events. Thus, infection and vaccine-related issues should be included in the individualized patient-specific treatment strategy and counseling before starting therapy and regularly on treatment. Clinical and epidemiological studies as well as pharmacovigilance data repeatedly demonstrated the safety of the great majority of vaccines in multiple sclerosis patients. Moreover, studies have shown that vaccinations with kil…

Bayesian approach to urinary ESBL-producing Escherichia coli

2014

This is a retrospective study about the prevalence of ESBL-producing Escherichia coli (EEC) in urinary specimens from patients from the Comunitat Valenciana from January 2007 to December 2008. Data were retrieved from RedMIVA, and Bayesian generalized linear mixed models were considered to study the prevalence of EEC with regard to demographical and microbiological factors. The total number of infections considered was 164,502, the amount of urinary isolates was 70,827 belonging to 49,304 different patients, and 5,161 (7.3%) of the urinary isolates were EEC. Three out of four E. coli were isolated in women (76.8%), men showed higher rates of EEC (9.7% in men vs. 6.5% in women). EEC patients…

Atypical thrombosis associated with VaxZevria (R) (AstraZeneca) vaccine: Data from the French Network of Regional Pharmacovigilance Centres

2021

The current COVID-19 pandemic is an exceptional health situation including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different candidates were proposed. In this short article, we present the French public pharmacovigilance activities during this health crisis. Although COVID-19 is a confounding factor per se, owing to its potential for multi-organ damage including the heart and kidney, the quality of the transmitted data in adverse drug reaction reports, the timeliness of feedback from clinicians, and the real-time pharmacological and medical analysis by the French network of the regional pharmacovigilance centers made it possible to s…

Type I interferons as the potential mechanism linking mRNA COVID-19 vaccines to Bell's palsy

2021

Therapies - Sous presse. Epreuves corrigees par l'auteur. Disponible en ligne depuis le mardi 13 avril 2021

Incidence of severe COVID-19 outcomes in psoriatic patients treated with systemic therapies during the pandemic: A Biobadaderm cohort analysis

2021

Gender differences in adverse drug reactions in dermatological patients in west Sicily: an epidemiological study

2013

Purpose: The purpose of this study was to show that gender also plays an important role in pharmacokinetics, pharmacodynamics, and drug toxicity. It is only fair to take into account the so-called “gender-based medicine.” Methods: We again selected admission for cutaneous adverse drug reaction (CADRs), from January 2012 to July 2012, in order to detect and verify, in an analytical way, the substantial gender differences in adverse drug reactions in term incidence, clinical manifestations, severity and drugs involved. Results:In the period January–July 2012, at the Department of Dermatology and Sexually Transmitted Disease of A.O.U.P. “Paolo Giaccone” Palermo, 384 patients were admitted, of …

Agomelatine and Hepatotoxicity: Implications of Cumulated Data Derived from Spontaneous Reports of Adverse Drug Reactions

2013

Considering the antidepressant agomelatine (AGM) there is a discrepancy between the widespread knowledge of the potential of AGM to cause hepatotoxic adverse drug reactions (ADR) and the availability of corresponding published data. This impedes an adequate assessment of the hepatotoxicity profile of AGM. We conducted a query of the database of a German Medical Regulatory Body (BfArM) and analyzed spontaneous reports of hepatotoxic ADR. We identified n=58 cases of AGM-related hepatotoxic ADR. Most frequent ADR was asymptomatic increase of liver enzymes (79%); n=6 patients (10%) with AGM-related toxic hepatitis were reported. Characteristics of patients: female sex (69%), age > 50 years (mea…

Changing prevalence, clinical features, and outcome of acute hepatitis in Spain (1982-2003)

2006

Background:  Diagnostic and preventive measures have contributed to a change in the epidemiology of acute hepatitis. The purpose of the present paper was to assess the changing prevalence of acute hepatitis from 1982 to 2003. Methods:  Trends in the epidemiology, clinical findings, and outcome of acute viral hepatitis from 1982 to 2003 were examined. A total of 548 episodes of acute hepatitis diagnosed between 1982 and 2003, the clinical course of which was monitored up to the year 2003, were included. Annual changes as well as for the intervals 1982–1992 and 1993–2003 were compared. Results:  Severe infections occurred in 1.3% of cases, with a mortality of 0.6%, with progression into chron…

Non-fatal and fatal liver failure associated with valproic acid.

2012

Little is known about hepatotoxicity associated with valproic acid (VPA), a widely used substance in neuropsychiatry.All reported cases to the German Federal Institute for Drugs and Medical Devices between 1993 and 2009 of VPA-induced serious hepatic side effects were evaluated.A total of 132 cases of serious VPA-associated liver failure were identified. Approximately one third (34.8%) occurred under VPA monotherapy, while the majority was seen with VPA plus co-medication, most frequently antiepileptics (34.8%) and benzodiazepines (16.7%). A subgroup of 34 cases (25.8%) had a fatal outcome, the largest number reported to date. Of these, 32.4% were under VPA monotherapy and 67.6% under VPA p…

Natalizumab: a country-based surveillance program

2008

Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (S…