Drug Safety
-
Nesiritide is a recombinant form of human B-type natriuretic peptide, a naturally occurring endogenous hormone released by cardiac ventricles in response to an increase in ventricular wall stress. Its use in the treatment of acute decompensated heart failure (ADHF) has been evaluated in a series of randomised controlled clinical trials. It is currently approved in the US for the treatment of ADHF. ⋯ However, reviews of large, observational, registry databases do not suggest an adverse inpatient mortality effect compared with other vasodilator therapies. Further resolution of the mortality question awaits completion of pending randomised controlled clinical trials. When used for approved indications and according to recommended dosage and administration regimens, nesiritide represents a reasonable treatment adjunct for ADHF.
-
The WHO Foundation Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre [UMC]) has received many individual case safety reports (ICSRs) associating HMG-CoA reductase inhibitor drug (statin) use with the occurrence of muscle damage, including rhabdomyolysis, and also peripheral neuropathy. A new signal has now appeared of disproportionally high reporting of upper motor neurone lesions. ⋯ We emphasise the rarity of this possible association, and also the need for further study to establish whether a causal relationship exists. We do advocate that trial discontinuation of a statin should be considered in patients with serious neuromuscular disease such as the ALS-like syndrome, given the poor prognosis and a possibility that progression of the disease may be halted or even reversed.
-
Meta Analysis
An evaluation of the cardiovascular safety profile of duloxetine: findings from 42 placebo-controlled studies.
In recent years, new classes of medication, such as the serotonin-noradrenaline reuptake inhibitors (SNRIs), have been developed for use in the treatment of major depressive disorder (MDD). For many years, treatment options were largely limited to the use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). However, there have been published reports of orthostatic hypotension, arrhythmias and corrected QT (QTc) interval changes in patients treated with TCAs. As new medications become available, it is important to understand how their cardiovascular safety profile compares with that of more established agents to aid clinicians and patients in choosing the best treatment options. This study was designed to evaluate the cardiovascular safety profile of the SNRI duloxetine through evaluation of cardiovascular-related parameters and adverse events (AEs). ⋯ Overall, the findings presented here support our conclusions that use of duloxetine does not appear to be associated with significant cardiovascular risks in patients with conditions for which the drug has been approved or studied.
-
Children are a particularly challenging group of patients when trying to ensure the safe use of medicines. The increased need for calculations, dilutions and manipulations of paediatric medicines, together with a need to dose on an individual patient basis using age, gestational age, weight and surface area, means that they are more prone to medication errors at each stage of the medicines management process. It is already known that dose calculation errors are the most common type of medication error in neonatal and paediatric patients. ⋯ Unit dose dispensing systems and educational/risk management programmes were also shown to reduce medication errors in children. Although it is suggested that 'smart' intravenous pumps can potentially reduce infusion errors in children, there is insufficient information to draw a conclusion because of a lack of research. Most interventions identified were US based, and since medicine management processes are currently different in different countries, there is a need to interpret the information carefully when considering implementing interventions elsewhere.
-
Severe sepsis is a common cause of death in critically ill patients. Several mechanisms have been implicated in the development of organ dysfunction in patients with severe sepsis. Among these, activation of inflammation and coagulation, together with endothelial dysfunction, seem to be major contributors. ⋯ Importantly, bleeding did not outweigh the benefits of drotrecogin alfa (activated), as there was an overall survival benefit, provided only patients at high risk of death from sepsis were treated with drotrecogin alfa (activated). The bleeding rate associated with drotrecogin alfa (activated) was slightly higher in cohort studies than in clinical trials, but this may be related to the higher severity of illness in these patients. Thus, in clinical practice, great caution should be taken in the selection of patients to be treated, and unnecessary invasive procedures should be avoided in order to preserve the survival benefit conferred by drotrecogin alfa (activated).