The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.

Chimeric antigen receptor (CAR)-engineered T-cell therapy is becoming one of the most promising approaches in the treatment of cancer. On June 28, 2018, the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kymriah for pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse after transplant, or in second or later relapse and for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah became one of the first European Union-approved CAR T therapies.

Risk of fetal death after pandemic influenza virus infection or vaccination.

Background: During the 2009 influenza A (H1N1) pandemic, pregnant women were at risk for severe influenza illness. This concern was complicated by questions about vaccine safety in pregnant women that were raised by anecdotal reports of fetal deaths after vaccination.

Methods: We explored the safety of influenza vaccination of pregnant women by linking Norwegian national registries and medical consultation data to determine influenza diagnosis, vaccination status, birth outcomes, and background information for pregnant women before, during, and after the pandemic.

[Adverse events related to substitution of generic products in Norway 2005].

Background: The Norwegian Medicines Agency has since 2003 encouraged health professionals to report adverse events (AEs) related to generic substitution through the spontaneous reporting system. Goals of this study were to evaluate the quality of these reported AEs and to assess whether there were signals of altered efficacy or AEs related to substitution of such products.

Material And Methods: The World Health Organisation's (WHO) tool for documentation grading was used to evaluate the AE reports.

[Can the screening of blood samples identify adverse drug reactions?].

Background: Analysis of blood samples may identify adverse drug reactions (ADRs) and risk situations. The study objective was to validate a method for in-hospital detection of ADRs based on screening of blood samples.

Material And Methods: Routine blood samples from patients in a geriatric ward were screened according to simple decision criteria to identify ADRs.

Characteristics and quality of adverse drug reaction reports by pharmacists in Norway.

Purpose: To evaluate the characteristics and quality of adverse drug reaction (ADR) reports submitted by pharmacists, and thereby assess the possible contribution of pharmacists to the spontaneous reporting system for ADRs in Norway.

Methods: An open, prospective study was conducted where dispensing pharmacists from 39 pharmacies were encouraged to report ADRs over a 3-month period. The submitted ADR reports were compared to reports by physicians from the same time period.

Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway.

Background: In Scandinavian countries, pharmacists have not reported adverse drug reactions (ADRs), either due to legislative restrictions or because of lack of tradition. From 1 January 2005, Norwegian pharmacists have been encouraged by the Norwegian Medicines Agency to take a larger role in the reporting of ADRs.

Objective: To explore pharmacists' attitudes towards pharmacovigilance and their experiences with ADR reporting, to evaluate the effect of an educational programme and to compare these findings to the attitudes in a control group.

Adverse events after naloxone treatment of episodes of suspected acute opioid overdose.

Objective: An increasing and serious heroin overdose problem in Oslo has mandated the increasing out-of-hospital use of naloxone administered by paramedics. The aim of this study was to determine the frequencies and characteristics of adverse events related to this out-of-hospital administration by paramedics.

Methods: A one-year prospective observational study from February 1998 to January 1999 was performed in patients suspected to be acutely overdosed by an opioid.

Adverse drug events in children during hospitalization and after discharge in a Norwegian university hospital.

Unlabelled: The frequency and characteristics of adverse drug events (ADEs) in children hospitalized in the paediatric department of Ullevaal University Hospital, Norway, were determined using intensive monitoring. Of 579 children treated with drugs, 28% experienced ADEs; 7% at the time of admission, 18% during hospitalization and 9% after discharge. All children treated for cancer, 19% treated with anti-infective drugs, 15% treated with antiasthmatics and 10% treated with drugs affecting the nervous system experienced ADEs.

Drug-related deaths in a department of internal medicine.

Background: Drug therapy is associated with adverse effects, and fatal adverse drug events (ADEs) have become major hospital problems. Our study assesses the incidence of fatal ADEs in a major medical department and identifies possible patient characteristics signifying fatal ADE risk.

Methods: During a 2-year period, a multidisciplinary study group examined all 732 patients who died--5.

Fatal adverse drug events: the paradox of drug treatment.

Objective: Study patient characteristics, morbidity patterns and drug regimens associated with fatal adverse drug events (FADEs) amongst medical department inpatients.

Design: An observational, descriptive study using aggregated medical records, autopsies and pre and postmortem drug analyses.

Setting: A department of internal medicine at a Norwegian county hospital.

[Statins--the pattern of adverse effects with empahsis on mental reactions. Data from a national and an international database].

We report on adverse drug reactions to statins recorded internationally and in Norway. The use of HMG-CoA reductase inhibitors (statins) has increased with a factor of 30 in Norway over the period 1989-96. Recently published clinical trials conclude that statins are safe; adverse drug reactions being infrequent and non-serious.

[Frequency, reporting and classification of drug-related deaths].

In order to reach an estimate of drug-related deaths, the Adverse Drug Reaction Committee/the Norwegian Medicines Control Authority obtained access to data from the Department of Internal Medicine in a Norwegian county hospital. The criteria for classifying possible/probable cause of drug-related deaths were assessed. 6.

[Drugs as a cause of death. A prospective quality assurance project in a department of medicine].

This study is part of a prospective quality assurance project in a Norwegian county hospital. The major aims of the study were to estimate the number of drug-related deaths; assess whether these were recognized by the clinicians, and (if not) discuss why the clinicians had difficulties in recognizing drug-related deaths. A panel of two internists, one pathologist, one pharmacologist and one pharmacist evaluated all inpatients deaths over a six-month period.

Intestinal handling of bisacodyl and picosulphate by everted sacs of the rat jejunum and stripped colon.

Bisacodyl (BIS) is the acetic acid di-ester of the laxative diphenol 2-(4,4'-dihydroxydiphenyl)methyl-pyridine. A HPLC-method which permits the simultaneous determination of BIS and its monodesacetylated (MONO) as well as totally desacetylated (DES) form, has been used to study the intestinal handling of BIS (20 nmol/ml), when the compound was incubated for 60 min. at the mucosal side of the preparations specified.