Search results for "pharmacovigilance"
showing 10 items of 50 documents
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…
Thrombotic complications of vaccination against SARS-CoV-2: what pharmacovigilance reports tell us – and what they don't
2021
In the present issue of the Journal [1], Smadja et al. present an analysis of global pharmacovigilance reports of thrombotic events following severe acute respiratory distress syndrome coronavirus (SARS-CoV)-2 vaccination. More specifically, the authors analysed the data entered into the World Health Organization (WHO) Global Database for Individual Case Safety Reports (VigiBase) between December 13, 2020 and March 16, 2021, covering, at that time, a population of almost 362 million vaccinated individuals across the world. The study focuses on three of the coronavirus disease (COVID)-19 vaccines available to date, namely the Pfizer-BioNtech (BNT162b2), Moderna (mRNA-1273), and OxfordAstraZe…
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
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).…
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…
Impact of physicians’ participation in non-interventional post-marketing studies on their prescription habits: A retrospective 2-armed cohort study i…
2020
Background Non-interventional post-marketing studies (NIPMSs) sponsored by pharmaceutical companies are controversial because, while they are theoretically useful instruments for pharmacovigilance, some authors have hypothesized that they are merely marketing instruments used to influence physicians’ prescription behavior. So far, it has not been shown, to our knowledge, whether NIPMSs actually do have an influence on prescription behavior. The objective of this study was therefore to investigate whether physicians’ participation in NIPMSs initiated by pharmaceutical companies has an impact on their prescription behavior. In addition, we wanted to analyze whether specific characteristics of…
Pharmacy and pharmacology of biosimilars
2008
Biosimilar medicines are biological medicinal products that can obtain a marketing authorization in the EU after the original product (biological reference medicine) has run out of patent. As a prerequisite, studies including clinical trials are to be conducted to compare the quality, safety, and efficacy of the biosimilar and reference medicine. Due to the specific characteristics of biopharmaceuticals like complex 3-dimensional (glyco) protein structure, immunogenicity, production in living organisms, which causes heterogeneity, complex manufacturing process and analysis, interchangeability of the biosimilar with its reference drug product is not guaranteed. In addition, INN (internationa…
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…
Timely recognition of cardiovascular toxicity by anticancer agents: a common objective of the pharmacologist, oncologist and cardiologist.
2011
Both conventional and new anticancer drugs can frequently cause adverse cardiovascular effects, which can span from subclinical abnormalities to serious life-threatening and sometimes fatal events. This review examines the principal basic and clinical elements that may be of profit to identify, prevent and treat such toxicities. Clearly, the accomplishment of such objectives requires the strong commitment and cooperation of different professional figures including, but not limited to, pharmacologists, oncologists and cardiologists. The aspect of anticancer drug cardiotoxicity seems to be somehow underestimated, mainly due to inadequate reporting of adverse reactions from oncology drugs in t…
Adverse drug reactions in some African herbal medicine: literature review and stakeholders’ interview
2014
International audience; Background: In view of the large consumption of herbal medicine in Africa countries, it is likely that many adverse drugs reactions go unrecorded with either patients failing to present to health services, or no pharmacovigilance analysis being made, or the analysis not being reported centrally. This problem is of interest especially for those who are working in the general area of adverse drug reactions or stakeholders in the domain of herbal medicine for considering safety issues. Methods: We are particularly interested in the way that the use of very wellknown and highly valued plants is linked to the observation of adverse drug reactions in African countries. We …