Search results for "PHARMACOVIGILANCE"
showing 10 items of 50 documents
Traditional Chinese medicine research in the post-genomic era: good practice, priorities, challenges and opportunities.
2012
Abstract Background and aims GP-TCM is the 1st EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. This paper aims to summarise the objectives, structure and activities of the consortium and introduces the position of the consortium regarding good practice, priorities, challenges and opportunities in TCM research. Serving as the introductory paper for the GP-TCM Journal of Ethnopharmacology special issue, this paper describes the roadmap of this special issue and reports how the main outputs of the ten GP-TCM work packages are integrated, and have led to consortium-wide conclusions. Materials and methods Literature studies, opinion polls and di…
Digoxin-related leukocytoclastic vasculitis in a very elderly woman: A case report
2016
International audience; Even though digoxin causes many side effects, few cases of skin involvement are recorded in the French Pharmacovigilance Database. We report a case of leukocytoclastic vasculitis (LV) very probably due to digoxin. A 91-year-old woman, hospitalized following a fall, presented cardiac decompensation in a context of rapid atrial fibrillation requiring treatment with digoxin. Eight days later, a rash appeared on her back and trunk. It was neither itchy, nor painful and persisted despite local treatment. There were no other clinical anomalies. After a few days, the rash spread with appearance of bullous lesions, ulcerations and a necrosis on lymphedema of the two legs. Am…
Antibiotic prophylaxis for the prevention of infective endocarditis for dental procedures is not associated with fatal adverse drug reactions in Fran…
2018
Background One of the major reasons to stop antibiotic prophylaxis (AP) to prevent infective endocarditis (IE) in the United Kingdom but not in the rest of the world was that it would result in more deaths from fatal adverse drug reactions (ADRs) than the number of IE deaths. The main aim of this study was to quantify and describe the ADRs with amoxicillin or clindamycin for IE AP. The second aim was to infer a crude incidence of anaphylaxis associated with amoxicillin for IE AP. Material and Methods The Medical Dictionary for Regulatory Activities (MedDRA) was used to group ADRs for IE AP using the broad Standardized MedDRA Queries “Anaphylactic reaction, Amoxicillin, Clindamycin, Clostrid…
Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance
2021
Introduction Immune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with the development of immune-related adverse drug reactions (ADRs). Among immune-related ADRs, cardiac immune-related ADRs are rare, but also associated with high mortality rates. Objective The objective of this study was to evaluate the occurrence of cardiac ADRs reported with ICIs in the European spontaneous reporting system. Methods We retrieved individual case safety reports on ICI-induced cardiac ADRs from the website of suspected ADR (www.adrreports.eu) of the European pharmacovigilance database (Eudravigilance).…
Drug-Induced Liver Injury Associated With Antidepressive Psychopharmacotherapy: An Explorative Assessment Based on Quantitative Signal Detection Usin…
2015
Drug-induced liver injury is a major problem of pharmacotherapy and is also frequent with antidepressive psychopharmacotherapy. However, there are only few studies using a consistent methodologic approach to study hepatotoxicity of a larger group of antidepress ants. We performed a quantitative signal detection analysis using data from the Uppsala Monitoring Centre from the WHO that records adverse drug reaction (ADR) data from worldwide sources; we retrieved substance- and country-specific (Australia, France, Germany, Italy, Spain, the United Kingdom, and the United States) ADR data and calculated reporting odds ratios as measures for disproportionality within a case/noncase approach. To a…
[Adverse reactions to human papillomavirus vaccine in the Valencian Community (2007-2011)].
2014
Introduction: In 2009, two cases of seizures in adolescents following quadrivalent human papillomavirus vaccine (qHPV) administration generated important media attention, and adversely affected public trust in this vaccine. Our objectives were to describe suspected adverse reactions (SARs) reported to the Pharmacovigilance Centre in the Valencian Community (PCVC) after administration of HPV vaccine, and to compare reporting rates of syncope and seizures following this vaccine with those of other vaccines administered to girls aged 13–15 years. Materials and methods: Descriptive study of SARs reported following administration of this vaccine to the PCVC between 2007 and 2011. Results: The cl…
Problem solving in psychopharmacotherapy using pharmacokinetic and pharmacogenetic tests
2007
Many problems such as non-response, pharmacokinetic interactions with clinical consequences and adverse effects (pharmacovigilance) may be observed in patients submitted to psychopharmacotherapy. These risks are increased in patients belonging to the category of “special populations”: elderly patients, children and adolescents, patients with a genetic particularity of metabolism or suffering from somatic or psychic comorbidities. Pharmacokinetic and pharmacogenetic tests are useful to solve problems in psychopharmacotherapy and thus improve efficacy and safety. Therapeutic drug monitoring (TDM) is particularly recommended in situations presented above and in patients who are non-compliant. …
The evolution of European Medicines Agency drug approval: the adaptive licensing: Table 1
2015
In March 2014, the European Medicines Agency (EMA) launched a pilot project of ‘adaptive licensing’ to speed up access to drugs in development, in order to respond to unmet medical needs. The project will involve parallel scientific advice from the regulatory agency, pharmaceutical industry, the companies Health Technology Assessment (HTAs) bodies, organisations studying guidelines on clinical treatment and patient associations. The traditional process of drug authorisation is divided into several parts, involving in vitro studies and in vivo studies in animals (preclinical studies), as well as phase 1–3 randomised controlled trials conducted in humans over a predefined period. When authori…
THE ROLE OF THE CLINICAL PHARMACIST IN THE MANAGEMENT OF ANTIRETROVIRAL THERAPY
2020
Over the last few years, the Hospital Pharmacy has developed in an excellent way in Europe, proposing in many countries the clinical pharmacist as a new professional figure, and adapting its responsibilities to national health systems. The purpose of this study is to evaluate and promote the prescriptive appropriateness through the close collaboration between the pharmacist and the medical team. The aspect of the dispensation of antiretroviral therapy was deepened by providing useful information to the patient on the possible undesired effects and interactions due to the polypharmacy, on the correct way of storing the drugs, and on the importance of the regularity of the polypharmacy intake…
Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in De…
2020
Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry. Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Results: O…