Posts Tagged adverse effects

[Abstract] Affective and behavioral dysfunction under antiepileptic drugs in epilepsy: Development of a new drug-sensitive screening tool

Highlights

  • Behavioral problems (e.g., depression) in epilepsy are common but usually of mild severity.
  • 30 AED-sensitive items were discerned from the BDI-I, NDDI-E, and FPZ.
  • Items were classified into six scales, constituting the new screening tool “PsyTrack”.
  • PsyTrack subscale scores differed as a function of drug load and presence of AEDs with negative psychotropic effects.
  • Generally, monotherapy seems to be favorable in terms of behavioral adverse effects.

Abstract

Objective

Behavioral problems and psychiatric symptoms are common in patients with epilepsy and have a multifactorial origin, including adverse effects of antiepileptic drugs (AEDs). In order to develop a screening tool for behavioral AED effects, the aim of this study was to identify behavioral problems and symptoms particularly sensitive to AED drug load and the presence/absence of AEDs with known negative psychotropic profiles.

Methods

Four hundred ninety-four patients with epilepsy were evaluated who had been assessed with three self-report questionnaires on mood, personality, and behavior (Beck Depression Inventory, BDI; Neurological Disorders Depression Inventory for Epilepsy extended, NDDI-E; and Fragebogen zur Persönlichkeit bei zerebralen Erkrankungen, FPZ). Drug-sensitive items were determined via correlation analyses and entered into an exploratory factor analysis for scale construction. The resulting scales were then analyzed as a function of drug treatment.

Results

Analyses revealed 30 items, which could be allocated to six behavioral domains: Emotional LabilityDepressionAggression/IrritabilityPsychosis & SuicidalityRisk- & Sensation-seeking, and Somatization. Subsequent analysis showed significant effects of the number of AEDs on behavior, as in Emotional Lability (F = 2.54, p = .029), Aggression/Irritability (F = 2.29, p = .046), Psychosis & Suicidality (F = 2.98, p = .012), and Somatization (F = 2.39, p = .038). Affective and behavioral difficulties were more prominent in those patients taking AEDs with supposedly negative psychotropic profiles. These effects were largely domain-unspecific and primarily manifested in polytherapy.

Conclusion

Drug-sensitive behavioral domains and items were identified which qualify for a self-report screening tool. The tool indicates impairments with a higher drug load and when administering AEDs with negative psychotropic profiles. The next steps require normalization in healthy subjects and the clinical validation of the newly developed screening tool PsyTrack along with antiepileptic drug treatment.

via Affective and behavioral dysfunction under antiepileptic drugs in epilepsy: Development of a new drug-sensitive screening tool – Epilepsy & Behavior

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[WEB SITE] Keppra – The Law Offices of Gregory Krasovsky

 

Keppra

The dangerous drug attorneys at the Law Offices of Gregory Krasovsky can provide legal advice and representation to individuals and families considering pursuing a Keppra lawsuit. In order for a plaintiff to secure a maximum settlement in litigation of a Keppra claim, regardless of whether in an individual lawsuit or in a class action lawsuit, it is crucial that the law firm representing you have a competent and experienced team of Keppra lawyers to guide you through all of the legal hurdles as well as direct you to sufficient funding (litigation funding or legal finance) to cover pharmaceutical litigation costs. Contact  a Keppra attorney today to schedule a free consultation and take your first step to obtaining compensation for losses caused by Keppra side effects.

Keppra, which is generically known as Levetiracetam, is an anticonvulsant drug used to treat epilepsy. Keppra was originally manufactured and marketed by UCB Pharmaceuticals Inc., but now it is available as a generic and is manufactured by a number of firms. Unfortunately, Keppra has a number of serious side effects that can, at times, outweigh its benefits for people who are suffering from epilepsy. Some of the most serious Keppra adverse effects include suicidal tendencies and birth defects.

There are many Levetiracetam side effects. These include, but are not limited to, the following:

  • Suicidal Ideation
  • Suicidal Tendencies
  • Suicide
  • Headache
  • Unsteady Walk
  • Depression
  • Hallucinations
  • Fever
  • Sore Throat
  • Mood Changes
  • Changes in Skin Color
  • Anxiety
  • Birth Defects

A 2005 Food and Drug Administration (FDA) study of suicidal ideation in relation to epilepsy drugs has indicated that people taking those drugs, such as Keppra, are twice as likely to suffer from suicidal thoughts as are those who have not been taking these drugs.

Unlike many other drugs, such as Wellbutrin, people taking Keppra are likely to experience suicidal ideation regardless of what age group they might happen to fall into. The aforementioned study tracked almost 30,000 people, and the rick of suicide was spread fairly evenly across the population. Of the 28,000 people who had taken Keppra in this study, four of them had actually committed suicide. These unfortunate incidents serve to confirm the danger of this unsafe drug.

Although Keppra’s ability to cause birth defects is still under investigation, there is some amount of evidence that seems to confirm that Keppra is more harmful to unborn babies than was previously thought. Currently, the FDA has placed Keppra in the Category C for pregnancy, which indicates that there is little human risk. However, AdverseEvents, Inc. believes that Keppra should perhapd be in Category D, which indicates that a significant enough risk to pregnancy exists.

Keppra is similar to another prototypical nootropic drug called piracetam. Keppra is also thought to be a possible treatment for Tourette syndrome, autism, bipolar disorder, and anxiety disorder.

The attorneys at this Keppra law firm believe that drugs should not cause the same ailments that they are meant to cure. If you or your loved one has been injured as a result of taking Keppra, you might be entitled to compensation. Contact our attorneys today to schedule a free consultation.

Source: Keppra – The Law Offices of Gregory Krasovsky

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[Abstract] Can High-Dose Levetiracetam Be Safe? A Case Report of Prolonged Accidental High-Dose Levetiracetam Administration and Review of the Literature

Levetiracetam is an antiepileptic drug that has been used both as adjunctive therapy and monotherapy in pediatric patients with epilepsy. We report a patient with cerebral palsy and epilepsy who took 200 mg/kg per day of levetiracetam for 55 days with no apparent adverse effects. Four other cases of accidental overdose were found in the literature; none of these was associated with any apparent adverse effects. These findings suggest that, in at least some cases, levetiracetam doses much higher than the recommended maximum of 60 mg/kg per day can be administered without apparent adverse effects.

Source: Can High-Dose Levetiracetam Be Safe? A Case Report of Prolon… : Clinical Neuropharmacology

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[ARTICLE] High doses of incobotulinumtoxinA for the treatment of post-stroke spasticity: are they safe and effective? – Full Text 

1. Introduction

Botulinum toxin type A (BoNT-A) represents the gold standard therapy for focal spasticity and related disorders also in acquired brain injury including stroke. Since 1989, the effectiveness of BoNT-A in reducing poststroke spasticity showed reversibility and low prevalence of complications [1], obtaining the approval of U.S. Food and Drug Administration for upper limb spasticity after stroke in 2010. In the following years, many studies have been published demonstrating its safety and effectiveness [2,3]. However, the role of BoNT-A in the management of poststroke spasticity has been modified, changing from muscle chemodenervation (nerve block) to become an useful tool for improving limb posture, applying splint, consenting hygiene, standing, and walking in patients with spastic equino-varus foot deformities with also improvement joint range of motion and muscle extensibility or reduction of spasticity-related pain.
The correct evaluation of the patient to be injected is necessary to increase the efficacy of BoNT-A considering that there is a high response for improving passive function, but controversy also exists about the improvement in motor function relative to the improvement of spasticity. There are proposals on dosages, injection techniques, patient selection, and outcome measures, but a consensus about the employment of adjunctive therapies after the BoNT-A injection, considered necessary to increase the effect on spasticity reduction, has not been reached, considering the time to start, the duration of adjunctive therapies, and the type of rehabilitation procedures [4]. So, at present, the injection sites, the choice of muscles, the dosage, the dilution, and the rehabilitation programs after BoNT-A treatment are often identified by injector’s decision-making without specialized training.
BoNT-A has clearly been recommended as first-line treatment for focal spasticity by several European consensus statements and the American Academy of Neurology [4,5] and current guidelines suggested the employment of a dose up to 600 units (U) of onabotulinumtoxinA (Botox®, Allergan, Inc., Irvine, CA, USA) and incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH, Frankfurt, Germany) or up to 1500 U of abobotulinumtoxinA (Dysport®, Ipsen, Slough, UK/Galderma, Paris, France) per injection session to treat spasticity after stroke [5]. However, in recent years, higher doses have been used, especially in case of upper and lower limb severe spasticity considering the low prevalence of complications and the reversibility of the BoNT-A [6,7]. The possibility to employ high doses is strictly related to the precision of the injection. A correct muscle identification with instrumental guide (i.e. electrical stimulation or ultrasonography) may reduce the spread of the toxins to the nearby tissues and the risk of adverse effects.

Continue —> High doses of incobotulinumtoxinA for the treatment of post-stroke spasticity: are they safe and effective? – Expert Opinion on Drug Metabolism & Toxicology –

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