A case series of confusional states and other neurotoxic effects caused by ertapenem.

Ten cases of ertapenem neurotoxicity, mainly confusional states, are described, some of them with fatal outcomes. The majority of patients (90%) had a creatinine clearance (CrCl) < 50 mL/min/1.73m2 at some point during treatment and hypoalbuminaemia was always present when ertapenem treatment was started. The pharmacokinetic and pharmacodynamic properties of this carbapenem could favour a different profile, and approved doses can be excessive in some patients with moderate renal failure (CrCl 31-59 mL/min/1.73 m2 ). It may be necessary to re-evaluate renal function during treatment and adjust doses or reconsider the adequacy of treatment based on clinical judgement, especially if relevant changes in the CrCl occur (i.e. a reduction to ≤30 mL/min/1.73 m2 ) or unexplained behavioural disorders are detected. The onset of the symptoms of ertapenem neurotoxicity can be insidious and go unnoticed, and so a knowledge and early suspicion of confusional states are important to improve the patient prognosis.

Spontaneously Reported Adverse Drug Reactions and Their Description in Hospital Discharge Reports: A Retrospective Study.

The inclusion of spontaneously reported adverse drug reactions (ADRs) in hospital discharge reports was examined, in addition to the factors associated with their inclusion, the resulting therapeutic decisions, and any recommendations made upon patient discharge regarding the suspected offending drugs. ADRs that were spontaneously reported during 2017 and 2018 to the pharmacovigilance program were retrospectively analyzed. Information regarding patient characteristics, drug treatments, and ADRs was collected from the ADR notifications and from patient electronic medical records. The dependent variable was the mentioning of ADRs in the discharge reports, while characteristics of the ADRs, pharmacovigilance causality algorithms, and some of the suspected drugs themselves were the independent variables during bivariant analysis. A total of 286 reports of suspected ADRs from 271 patients (50.2% female; 77% adults) were included. Information regarding the ADRs was present in the discharge reports for 238 reports (83.2%); the ADR seriousness and the lack of potential alternative causes were the only associated factors. Withdrawal or withdrawal and substitution by an alternative drug were the most common therapeutic decisions, although often no recommendation was made. Overall, there is still room for improvement in terms of including information related to ADRs in hospital discharge reports.

Prognosis of status epilepticus in patients requiring intravenous anesthetic drugs (a single center experience).

PURPOSE: There is concern about the safety of anesthetic drugs (IVADs) in the management of status epilepticus (SE). To clarify this aspect, we aimed to assess the factors associated with a poor prognosis in SE requiring anesthetics. METHOD: We analyzed all SE requiring IVADs between October 2011 and December 2015. Demographics, clinical data, etiology, SE duration, indications for sedation, electroencephalography features, complications and the prognosis at discharge were collected. Hypoxic etiology was ruled out. RESULTS: 73 patients needed IVADs. These were indicated as third-line treatment for SE in 58.9%, for decreased level of consciousness resulting from previous treatments in 27.4%, and for the underlying etiology in 13.7%. At discharge 41(56.2%) patients showed a bad outcome and 32 a good outcome. Outcome was poorer in patients with higher STESS (p=0.003), lower level of consciousness (p=0.025), non-convulsive SE in coma (p=0.040), potentially fatal etiology-PFE (p=0.006), longer duration (p=0.026), presence of complications (p=0.022), use of IVADs due to the underlying etiology (p=0.020), and periodic epileptiform discharges on electroencephalography (p=0.032). Following multivariate analysis, SE duration >12h (OR=3.266; 95%CI=1.077-9.908; p=0.037), STESS ≥3 (OR=4.816; 95%CI=1.435-16.165; p=0.011), and PFE (OR=3.526; 95%CI=1.184-10.506; p=0.024) were independently associated with a poor functional prognosis. Regarding mortality, duration >12h (OR=7.07; 95%CI=1.836-27.220; p=0.004), low level of consciousness (OR=6.97; 95%CI=1.194-40.718; p=0.031), and presence of complications (OR=21.32; 95%CI=2.440-186.295; p=0.006) were independent predictors of death. CONCLUSIONS: Lengthy duration of SE in patients requiring IVADs is associated with a poorer prognosis and death. A STESS ≥3 and the etiology seem mainly related to the functional status at discharge, whereas more severely impaired consciousness and complications during sedation are related to mortality.