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Valproic Acid Toxicity

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121. Addyi - Flibanserin

in labeling. 4.2 Reproductive Toxicity Data in pregnancy were obtained from pregnant rats and rabbits; the July 16, 2015 pharm/tox review discussed the following data: Data in rats: During organogenesis, pregnant rats administered 400 mg/kg/day dose (the highest dose tested) was associated with “significant maternal toxicity as evidenced by severe clinical signs and marked reductions in weight gain during dosing. Decreased fetal weights, increases in the incidence of decreased ossification (...) of the forelimbs and increased lumbar vertebrae, and two fetuses with anophthalmia were observed in the litters of high dose dams.” The no observed adverse effect level (NOAEL) for maternal and embryofetal toxicity was 80 mg/kg/day (15 times clinical exposure based on area under the curve, AUC). When pregnant rats were given flibanserin during Day 6 to Lactation Day 21 to assess peri- and post-natal development, all doses administered resulted in sedation and decreases in body weight gain during pregnancy

2015 FDA - Drug Approval Package

122. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

in fact be decreased [99,100]. Careful monitoring for evidence of self-harming or suicidal thoughts or behaviors is impor- tant inboth adult and pediatric patients. SSRIs and SNRIs are generally better tolerated and safer than TCAs and MAOIs, having less anticholinergic effects, toxicity, lethality, and psychomotor or cognitive impairment [85,101]. MAOIs are generally reserved for second- or third-line treatment because of side effects, drug interactions, and dietary restrictions [32]. Anxiolytics (...) therapies (see Sec- tions 3–9 for evidence and references). Anticonvulsants: Anticonvulsants are associated with gastrointestinal side effects, somnolence, weight gain, tremor, as well as dermatologic and hematologic side effects [111,118]. In addition, several anticonvulsants have a potential risk of serious rash, erythema multi- forme, Stevens-Johnson syndrome, or toxic epidermal necrolysis [111]. Regular monitoring of serum medica- tion levels and liver function is required for patients on divalproex

2014 CPG Infobase

123. Dissecting the Epigenetic Changes Induced by Non-Antipsychotic Mood Stabilizers on Schizophrenia and Affective Disorders: A Systematic Review Full Text available with Trip Pro

-antipsychotic mood stabilizers alter the epigenetic expression of a variety of candidate genes in bipolar disorder and schizophrenia. Findings from our systematic review suggest that epigenetic changes induced by mood stabilizers produce neuroprotective effects through different pathways. DNMT, DNA methyltransferase; HDAC, histone deacetylase; TF, transcription factor; RNAPII, RNA polymerase II; VPA, valproic acid; Li, lithium; CBZ, carbamazepine; LTG, lamotrigine; GAD67, glutamate decarboxylase 67; KCNQ3 (...) , antidepressant and prophylactic effects, have been characterized as the mainstay of treatment for BD and as aides in MDD and SCZ ( ; ). While mechanisms of action of valproic acid (VPA), carbamazepine (CBZ), lamotrigine (LTG), and lithium (Li) are not completely understood, there is robust evidence on their ability to target altered epigenetic functions ( ; ; ) involved in the pathophysiology of BD, MDD and SCZ ( ; ). The putative neuroprotective and neurotrophic actions of Li are thought to be induced

2020 Frontiers in pharmacology

124. Psychotropic drug concentrations and clinical outcomes in children and adolescents: a systematic review Full Text available with Trip Pro

drugs that were retrieved with our search, no relationship between concentration and clinical outcomes was found in either high-quality studies or lower-quality studies (dexamphetamine, paroxetine, imipramine, loxapine, valproic acid). Overall, findings were highly heterogeneous. Most studies were not primarily designed to assess the relationship between drug concentrations and effects. Furthermore, most of the studies were not replicated and for most drugs and outcomes, only one study was available (...) Prospective cohort CGI-BP CDRS-R X X X X Siegel et al., 2014 [ ] Lithium 30 (23) Autism Spectrum Disorder Retrospective cohort CGI-I X X Amitai et al., 2015 [ ] Valproic acid 104 (68) Children treated with VPA at a psychiatric ward Retrospective cohort WBCs, PLT counts, TSH, LFTs, amylase levels or metabolic parameters X X X Legend: a Number of subjects with analysis on drug concentrations and effect. Each drug assessed within a study represents a row in the table; one study can therefore be in the table

2020 Expert opinion on drug safety

125. Efficacy of antiepileptic drugs in neonatal seizures: a systematic review protocol Full Text available with Trip Pro

methods The following databases will be searched: PubMed, Embase, Web of Science, Cochrane Library and Clinical trial.gov. We will also screen the previous systemic review and related references for potential references. The search term will combine medical subject heading (MeSH) and free word. MeSH terms are as follows: “Infant, Newborn”, “Seizures”, “Valproic Acid”, “Paraldehyde”, “Phenobarbitone”, “Levetiracetam”, “Lorazepam”, “Carbamazepine”, “Phenytoin”, “Midazolam”, “Lidocaine”, “Fosphenytoin (...) efficacy in neonatal seizures. Neonatal seizures are associated with the development of cerebral palsy and epilepsy. What this study hopes to add? The effectiveness of new AEDs compared with old ones. Long-term outcomes in relation to cerebral palsy and epilepsy following neonatal seizures. The most common drug toxicity with different AEDs in neonates. INTRODUCTION Neonatal seizures are one of most common neurological complications in the neonatal intensive care unit (NICU), which have an incidence

2020 BMJ Paediatrics Open

126. Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®): Health Professional Version

to be higher for children with Down syndrome. Rare germline variants with high penetrance. Germline variants that cause pathogenic changes in genes associated with ALL and that are observed in kindreds with familial ALL (i.e., large effect sizes) comprise another category of genetic predisposition to ALL. PAX5 . A germline variant in PAX5 that substitutes serine for glycine at amino acid 183 and that reduces PAX5 activity has been identified in several families that experienced multiple cases of ALL (...) .[ - ] Cytogenetic and genomic findings combined with minimal residual disease (MRD) results can define subsets of ALL with EFS rates exceeding 95% and, conversely, subsets with EFS rates of 50% or lower (refer to the and sections of this summary for more information). Despite the treatment advances in childhood ALL, numerous important biologic and therapeutic questions remain to be answered before the goal of curing every child with ALL with the least associated toxicity can be achieved. The systematic

2018 PDQ - NCI's Comprehensive Cancer Database

127. Childhood Astrocytomas Treatment (PDQ®): Health Professional Version

at specific amino acids in histone genes, and together these account for approximately one-half of pediatric high-grade gliomas. The following pediatric high-grade glioma subgroups were identified on the basis of their DNA methylation patterns, and they show distinctive molecular and clinical characteristics:[ ] H3.3 ( H3F3A ) and H3.1 ( HIST1H3B and, rarely, HIST1H3C ) mutation at K27: The Histone K27–mutated cases occur predominantly in middle childhood (median age, approximately 10 years), are almost

2018 PDQ - NCI's Comprehensive Cancer Database

130. Panobinostat (Farydak)

information 5. Patient has grade >2 peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination within 14 days before randomization 6. Patient received prior treatment with deacetylase inhibitors including panobinostat 7. Patient needing valproic acid for any medical condition during the study or within 5 days prior to first administration of panobinostat/study treatment 8. Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted only if commenced (...) as deacetylase inhibitors, including valproic acid. Prophylactic anti-emetics such as granisetron could be administered at the discretion of the Investigator. However, anti-emetics

2014 FDA - Drug Approval Package

131. Prevention of Acute Nausea and Vomiting due to Antineoplastic Medication in Pediatric Cancer Patients

summary or in which the emetogenicity of the antineoplastic therapy administered was not able to be determined. Headache 44, 96, 97 and constipation 96 were often reported to be the most common adverse effects. Abnormal liver function tests were reported in 4 of 22 children in one study. 31 Two studies prospectively evaluated cardiovascular toxicity including continuous electrocardiographic monitoring for 24 hours after receipt of granisetron. 95, 98 No dysrhythmias were observed in 64 children

2013 SickKids Supportive Care Guidelines

132. A sub-chronic Xysmalobium undulatum hepatotoxicity investigation in HepG2/C3A spheroid cultures compared to an in vivo model. Full Text available with Trip Pro

kinase (AK). Sprague Dawley rats were treated with the same compounds over 21 days, with evaluation of in vivo toxicity effects on serum chemistry.The results from the in vitro study clearly indicated hepatotoxic effects and possible liver damage following treatment with valproic acid, with associated growth inhibition, loss of cell viability and increased cytotoxicity as indicated by reduced intracellular ATP levels and increased AK levels. These results were supported by the increased in vivo (...) the hepatotoxic and anti-prolific effects of the crude X. undulatum aqueous extract during a sub-chronic study (21 days), in both a 3D HepG2/C3A spheroid model and the Sprague Dawley rat model.HepG2/C3A spheroids were treated with a known hepatotoxin, valproic acid, and crude X. undulatum aqueous extract for 21 days with continuous evaluation of cell viability and proliferation. This was done by evaluating cell spheroid growth, intracellular adenosine triphosphate (ATP) levels and extracellular adenylate

2019 Journal of Ethnopharmacology

133. Renal replacement therapy in the management of intoxications in children: recommendations from the Pediatric Continuous Renal Replacement Therapy (PCRRT) workgroup. (Abstract)

, methotrexate, phenytoin, acetaminophen, salicylates, valproic acid, and aminoglycosides. (...) experts from the PCRRT (Pediatric Continuous Renal Replacement Therapy) workgroup assessed titles, abstracts, and full-text articles for extraction of data. The data from the literature search was shared with the PCRRT workgroup and two expert toxicologists, and expert panel recommendations were developed.We have presented the recommendations concerning the use of RRTs for treatment of intoxications with toxic alcohols, lithium, vancomycin, theophylline, barbiturates, metformin, carbamazepine

2019 Pediatric Nephrology

134. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum

(e.g. (NICE, 2015b)). • Consider high dose folic acid (5 mg/d) where folate- lowering drugs are used, although the evidence for its benefit has not been shown (Wlodarczyk et al., 2012) and there is a possibility that folate may decrease the efficacy of other drugs such as lamotrigine in bipolar disorder (Geddes et al., 2016). • Although there may be some potential advantages of changing medications early in pregnancy, by mid–trimes- ter there might be fewer, if any, advantages in changing (...) that these adverse neonatal outcomes are not attributable to antidepressants toxicity McAllister-Williams et al. 13 or withdrawal but rather to the underlying maternal disorder or concurrent exposures. One naturalistic observation study com- pared the outcomes of neonates exposed to SSRIs in the last 14 days of pregnancy and neonates exposed in pregnancy but not in the last two weeks, and found an increased risk of neonatal respi- ratory distress in the last-exposed group (Warburton et al., 2010). However, when

2017 British Association for Psychopharmacology

135. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage Full Text available with Trip Pro

randomized trial of 1-month prophylactic treatment with valproic acid showed no reduc- tion in incident seizures over 1-year follow-up (19.5% in the treatment group, 22.2% in the placebo group; P=0.8). 168 Prophylactic anticonvulsant medication has thus not been demonstrated to be beneficial. Clinical seizures or electrographic seizures in patients with a change in mental status should be treated with antisei- zure drugs. Continuous EEG monitoring should be considered in ICH patients with depressed

2015 American Heart Association

136. Management of an unprovoked first seizure in adults

appear to be mild and reversible when an affected patient is switched to another AED. , AEDs included phenytoin, phenobarbital, carbamazepine, valproic acid, and lamotrigine, , , , , some of which may now be considered older AEDs but were standard, commonly used AEDs at the time of the studies. Although AEDs may cause different AEs, most events are known to be dose-related and reversible through dose reduction or discontinuation of the responsible drug. , Evidence from reports of AED AEs (...) ” seizure). We excluded studies of provoked seizures, which are defined as seizures due to an acute symptomatic condition (e.g., a metabolic or toxic disturbance, cerebral trauma, stroke) and differ in prognosis from unprovoked seizures. , , , This practice guideline considers the evidence for prognosis and treatment of adults with an unprovoked first seizure; a 2003 guideline addresses this for children. We posed 3 questions: (1) What are the risks for seizure recurrence after a first seizure? (2) Does

2015 American Academy of Neurology

137. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage

randomized trial of 1-month prophylactic treatment with valproic acid showed no reduc- tion in incident seizures over 1-year follow-up (19.5% in the treatment group, 22.2% in the placebo group; P=0.8). 168 Prophylactic anticonvulsant medication has thus not been demonstrated to be beneficial. Clinical seizures or electrographic seizures in patients with a change in mental status should be treated with antisei- zure drugs. Continuous EEG monitoring should be considered in ICH patients with depressed

2015 Congress of Neurological Surgeons

138. Guidelines for the management of spontaneous intracerebral hemorrhage Full Text available with Trip Pro

reports. A small randomized trial of 1-month prophylactic treatment with valproic acid showed no reduction in incident seizures over 1-year follow-up (19.5% in the treatment group, 22.2% in the placebo group; P =0.8). Prophylactic anticonvulsant medication has thus not been demonstrated to be beneficial. Clinical seizures or electrographic seizures in patients with a change in mental status should be treated with antiseizure drugs. Continuous EEG monitoring should be considered in ICH patients

2015 American Academy of Neurology

139. Management of Substance Use Disorder

in 2000 were tobacco (435,000 deaths; 18.1% of total U.S. deaths), poor diet and physical inactivity (365,000 deaths; 15.2%), and alcohol consumption (85,000 deaths; 3.5%). Other causes of death were microbial agents (75,000), toxic agents (55,000), motor vehicle crashes (43,000), incidents involving firearms (29,000), sexual behaviors (20,000), and illicit use of drugs (17,000).[7] From 1990-2010, the highest disability-adjusted life years, which accounted for years of life lost due to premature

2015 VA/DoD Clinical Practice Guidelines

140. Evidence-based Guideline: Management of First Unprovoked Seizure in Adults

appear to be mild and reversible when an affected patient is switched to another AED. , AEDs included phenytoin, phenobarbital, carbamazepine, valproic acid, and lamotrigine, , , , , some of which may now be considered older AEDs but were standard, commonly used AEDs at the time of the studies. Although AEDs may cause different AEs, most events are known to be dose-related and reversible through dose reduction or discontinuation of the responsible drug. , Evidence from reports of AED AEs (...) ” seizure). We excluded studies of provoked seizures, which are defined as seizures due to an acute symptomatic condition (e.g., a metabolic or toxic disturbance, cerebral trauma, stroke) and differ in prognosis from unprovoked seizures. , , , This practice guideline considers the evidence for prognosis and treatment of adults with an unprovoked first seizure; a 2003 guideline addresses this for children. We posed 3 questions: (1) What are the risks for seizure recurrence after a first seizure? (2) Does

2015 American Epilepsy Society

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